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| Name | Class |
|---|---|
| Brain & Behavior Research Foundation | OTHER |
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Psychological treatments are effective, but take a long time and can be burdensome. Therefore, avenues to optimize behavioral treatments are needed. Despite important advancements, neuroscience has had a limited effect on psychotherapy development. Therefore, one paradigm shift would be to develop neuroscience informed behavioral treatments.
The investigators identified from the literature a problem that affects several mental disorders (emotion dysregulation) and a neural circuit that underlies this important concern. They found that this circuit is dysfunctional in those with psychopathology but can be changed with treatment. The goal is in one session to train this brain network to operate more efficiently and to test the short and long term effects of this intervention. The investigators plan to engage this brain network using a traditional psychotherapy strategy (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances the electrical activity in brain areas close to the scalp.
The study team proposed two studies to examine this novel approach, In one of the studies 83 participants were enrolled and 47 eligible participants were divided into 3 groups. All participants were trained in emotion regulation by first being asked to remember an event where they experienced a negative emotion and then being instructed either to think differently about the event, or to wait. Participants simultaneously underwent either active (left or right side of brain) or sham rTMS. In a second study 65 participants were enrolled, and 31 were assigned to either active left or sham rTMS guided using neuroimaging results. Across both studies, the investigators measured regulation in the lab and during a-week long naturalistic assessment. Participants in the second study returned for a follow up neuroimaging visit at the end of this week. Participants returned for a one moth follow up assessment and to rate feasibility, acceptability, and provide feedback. This proof of concept set of studies demonstrated feasibility and preliminary efficacy for this approach, which opens new frontiers for neuroscience informed treatment development.
Despite significant advancements in psychiatric research, the majority of adults with mental health disorders do not benefit from current evidence-based treatments, especially if they have difficulties managing negative emotions. One solution to this unmet clinical need is to take a neuroscience-informed approach to treatment development in order to radically change patient care. Despite an explosion of research on the neurobiological underpinnings of emotion, emotion regulation, and psychopathology, there have been few attempts to use such findings to advance behavioral treatments. Neuroscience-informed treatment development could optimize psychotherapy gains and reduce burden on therapists and clients. Therefore, we propose to build a fundamentally novel approach to treating difficulties managing negative emotions (or emotion dysregulation) that builds on the strength of current therapies, but that also accelerates and enhances gains.
Adults with several different psychiatric disorders have difficulty managing negative emotions, a problem that has been traced back to impairments in the fronto-limbic brain circuitry. In healthy samples this neural network is activated in response to tasks requiring regulation of emotional arousal and disrupting this circuit leads to psychiatric symptoms. In psychiatric samples, this circuit is underperforming as evidenced by (1) hyperactivity in the amygdala (the brain structure that signals emotional arousal), (2) slow return to baseline after amygdala activation, (3) hypoactivity in frontal regions (responsible for regulation), and (3) insufficient cross-talk between these regions when patients experience negative emotional arousal. Evidence-based cognitive-behavioral psychotherapy and neurostimulation are two different interventions that can remediate function in impaired brain circuits. Both interventions have evidence of success in changing the fronto-limbic network but also need improvement. Therefore, the investigators plan to combine magnetic brain stimulation and cognitive restructuring (an evidence-based behavioral treatment for difficulties managing emotions) in a one-session intervention.
The investigators recruited participants for two studies. In one study, 83 transdiagnostic adults (i.e., who meet criteria for any DSM 5 disorder) who engage in cognitive restructuring with low frequency as measured by an established questionnaire were enrolled and 47 were randomly assigned to either active (left or right) or sham repetitive transcranial magnetic stimulation (rTMS). In a second study, 65 transdiagnostic adult participants with high emotional dysregulation were enrolled, and 31 were randomly assigned to active left or sham rTMS guided using neuroimaging analyses. All included participants practiced reducing negative emotions (induced with standardized autobiographical stressors) using cognitive restructuring while undergoing high frequency or sham rTMS to the right or left dorsolateral prefrontal cortex. Standardized, established procedures were used to teach cognitive restructuring, to generate personalized stressors, to induce negative emotional arousal, and to implement the one session of rTMS. Immediate effects were evaluated using measures of emotional arousal and regulation during the intervention and for one week afterwards using 8 daily automated mobile phone calls. Long-term effects in emotion regulation, functional and psychiatric impairment were examined at 1-week and 1-month follow-up interviews.
Participants in the imaging portion of the study underwent an MRI before the intervention day. This imaging session included training in the emotion regulation task to be performed in the scanner, including practice in reappraisal and distraction; a memory cue assessment to rehearse cuing of memories; a mock scan if necessary, MRI safety screening confirmation, structural (Diffusion tensor imaging and anatomical) and functional MRI (fMRI) images will be collected. During the fMRI scan, participants completed the emotional regulation task where they were asked to recall an emotional memory from the Emotional Memory selection tasks and then be cued to reappraise, distract or allow negative emotions. At the end of the trials, participants rated their current emotional state. At the one week follow up, in addition to the tasks described above, they returned to complete a second MRI after 1 week where they were reoriented to the emotion regulation task, had structural and functional MRI images collected with the emotion regulation task occurring during the fMRI portion.
The investigators hypothesized that rTMS would enhance cognitive restructuring by yielding a quicker reduction in emotional arousal when compared to sham TMS, and would lead to more frequent use of the cognitive restructuring in the natural environment. This set of studies is intended to launch a series of investigations using innovative paradigms to optimize treatments for psychiatric disorders and it could lead to the next generation of neuroscience-informed behavioral interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Restructuring+rTMS (left) | Experimental | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. |
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| Cognitive Restructuring + sham rTMS | Sham Comparator | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. |
|
| Cognitive Restructuring+rTMS (right) | Experimental | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Restructuring | Behavioral | Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Return to Heart Rate Baseline During the Regulation Period During Training | The estimated marginal mean of the difference in length of time that it takes participants to reduce emotional arousal after three emotional inductions when they use Cognitive Restructuring (CR) with or without the enhancing effects of transcranial magnetic stimulation (TMS). Psychophysiological measurements were collected continuously using the BIOPAC MP-150. For each baseline, heart rate (HR) was averaged from the last 240s. Time to return to one's HR baseline was defined as the amount of time (e.g., number of seconds) it took from the beginning of regulation for the continuously monitored HR to reach a value that was lower than the average pre-stimulus baseline HR. Lower numbers indicate quicker regulation (desirable outcome). A baseline value for regulation duration was computed as the time it took during habituation for the person to return to HR baseline. Number of seconds was transformed with a logarithmic function for analyses to achieve normality. | 1 week after intake |
| Time to Return to Heart Rate Baseline During the Regulation Period at Follow up | The investigators will examine difference in length of time that it takes participants to reduce emotional arousal (as measured with physiological indicators) after an emotional induction when they use CR. This measure, was collected at the 1 month follow up assessment. Only one stressor-regulation period was presented at follow up. The number of seconds it took for participants to return to the pre-stimulus baseline during the regulation period was transformed with a log function for normality. Lower numbers indicate quicker regulation, a desirable outcome. | 1 month |
| Physiological Emotion Regulation | The investigators will record heart rate continuously throughout the intervention and then extract high frequency heart rate variability (an index of emotion regulation) from the regulation periods. Continuously recorded HR was divided into 120 s bins, and HF-HRV was extracted from cleaned raw ECG from each bin. Baseline HF-HRV was measured at the beginning of the experiment and right before each autobiographical stressor presentation. The treatment condition (active left, active right, or sham), baselines, the experimental condition (regulation 1, 2, and 3), and the time within each experimental condition (0 to 4 for each 120 s segment within that period) were used to predict HF-HRV. Higher HF-HRV indicates enhanced regulation, a desirable outcome. To make interpretation easier, the raw HF-HRV score was multiplied with 1000000. To achieve normality, this multiplied score was transformed with a logarithmic function. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability, as Measured by Qualitative Exit Interview | The investigators will examine how acceptable participants find the intervention. A previously developed in-house interview (A. D. Neacsiu, Luber, et al., 2018) was administered at the 1-month follow up, and it included Likert-type questions about feasibility, acceptability, and overall satisfaction rated on a scale from 0 (not at all) to 9 (extremely; secondary outcomes). |
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Inclusion Criteria:
Exclusion Criteria:
For imaging arm of the study, participants must also be able to tolerate an MRI, thus must be eligible based on the MRI safety screening form.
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| Name | Affiliation | Role |
|---|---|---|
| Andrada D Neacsiu, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center-Civitan Bldg | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Gross, J. J. Handbook of Emotion Regulation, Second Edition. (The Guilford Press, 2013). | ||
| 24974307 | Background | Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27. | |
| 26162113 |
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We enrolled 148 participants in both studies of which 78 were randomized in one of the two studies (main study or sub study). Twenty seven participants decided to withdraw after intake.In addition, 42 participants were excluded after enrollment (e.g., TMS was contraindicated, did not meet criteria for any DSM disorder, had current psychosis/mania/addiction, etc). One participant piloted the procedures and was also excluded from analyses.
Recruitment from the community occurred between 3/1/2016 and 2/17/2019 . Additional funding was received in 2017 to collect additional data. Two conditions were added where procedures were identical but targeting for neurostimulation was done using functional neuroimaging data. Participants were recruited for both the study and the sub study and assigned to one at intake.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Restructuring+rTMS (Left) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system. rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2019 |
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Participants were assigned to one of 2 studies (main and supplement) that ran concurrently. 83 participants were enrolled in the main study, and 65 in the supplement.
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| rTMS | Device | rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
|
| Sham rTMS | Device | Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
|
| 1 week after study start |
| Changes in Activation in the Neural Emotion Regulation Network | For groups 4 &5, the investigators collected functional imaging data while participants engaged in an emotion regulation task. We examined the BOLD response change in the contrast between down-regulating negative emotions and feeling negative emotions a week after intervention controlling for the maximum change in this contrast at intake. Specifically we examined changes in activation in the dorsolateral prefrontal cortex (dlPFC), ventrolateral PFC (vlPFC), ventromedial PFC (vmPFC), the amygdala and insula. Data were first preprocessed with fMRIprep and MRIQC. At the first level, functional data were analyzed as individual runs, using a general linear model (GLM) in which trial events were convolved with a double-gamma hemodynamic response function. The [Restructure- Feel_negative] contrast was then used to generate Level 2 analysis, in which BOLD activity for each of the four runs were combined using a fixed-effect model. Higher numbers indicate more activation (desired outcome). | 1 week |
| 1 month |
| Feasibility, as Measured by Qualitative Exit Interview | The investigators will examine how feasible the proposed intervention is. A previously developed in-house interview (A. D. Neacsiu, Luber, et al., 2018) was administered at the 1-month follow up, and it included Likert-type questions about feasibility, acceptability, and overall satisfaction rated on a scale from 0 (not at all) to 9 (extremely; secondary outcomes). | 1 month |
| Change in General Psychological Distress, as Measured by the Outcome Questionaire -45 | The investigators will examine change in general psychological distress after the intervention. The Outcome Questionnaire-45 (OQ-45) is a 45-item self-report measure used to track severity of psychopathology throughout treatment. It consists of subscales that identify three types of problems that lead to general stress: psychological symptoms, interpersonal conflicts, and problems with social roles. Items are rated on a Likert scale ranging from 0 (never) to 4 (almost always). We computed the total score (ranging from 0 to 180) from data collected at intake, at 1 week after the intervention, and at 1 month after the intervention. Higher score indicate higher psychopathological distress than lower scores. The estimated marginal means from the growth model comparing differences between conditions are presented in the table below. | 1 week and 1 month |
| Change in Daily General Emotional Distress | The investigators will examine change in emotional distress after the intervention as measured by daily mobile phone ratings 8 times/day for 7 days of subjective units of distress; SUDS). The 8 ratings/day will then be averaged into a mean/day. This daily SUDS mean (range 0-9) will be entered in analyses. Higher SUDS indicates more distress. | 1 week |
| Change in Emotion Dysregulation and Functional Impairment | The investigators will examine changes in the reappraisal scale of the Emotion Regulation Questionnaire (ERQ; range 1-7), in the total score from the Difficulties with Emotion Regulation Scale (DERS; range 36-180), and in the total score from the work and social adjustment functional impairment scale (WSAS; range 0-40) from before to after the one time intervention. Higher ERQ-Reappraisal scores indicate more use of cognitive restructuring (a favorable outcome). Lower DERS total score and lower WSAS average score indicate lower overall emotional dysregulation and lower impairment in functioning, which are desirable outcomes. Outcomes were analyzed using HLM models and the data presented below represents the estimate marginal means for each condition for the growth in each outcome controlling for baseline. | 1 week and 1 month after the intervention |
| Background |
| Kazdin AE, Blase SL. Rebooting Psychotherapy Research and Practice to Reduce the Burden of Mental Illness. Perspect Psychol Sci. 2011 Jan;6(1):21-37. doi: 10.1177/1745691610393527. Epub 2011 Feb 3. |
| 23729929 | Background | Luber B, Steffener J, Tucker A, Habeck C, Peterchev AV, Deng ZD, Basner RC, Stern Y, Lisanby SH. Extended remediation of sleep deprived-induced working memory deficits using fMRI-guided transcranial magnetic stimulation. Sleep. 2013 Jun 1;36(6):857-71. doi: 10.5665/sleep.2712. |
| 24095257 | Background | Feeser M, Prehn K, Kazzer P, Mungee A, Bajbouj M. Transcranial direct current stimulation enhances cognitive control during emotion regulation. Brain Stimul. 2014 Jan-Feb;7(1):105-12. doi: 10.1016/j.brs.2013.08.006. Epub 2013 Sep 21. |
| 3675137 | Background | Pitman RK, Orr SP, Forgue DF, de Jong JB, Claiborn JM. Psychophysiologic assessment of posttraumatic stress disorder imagery in Vietnam combat veterans. Arch Gen Psychiatry. 1987 Nov;44(11):970-5. doi: 10.1001/archpsyc.1987.01800230050009. |
| FG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
| FG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
| FG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
| FG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
| COMPLETED |
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| NOT COMPLETED |
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Completers (i.e., those who attempted and could complete the information). Those who were intent to treat who could not tolerate the intervention are not represented in these descriptive statistics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Restructuring+rTMS (Left) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system. rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
| BG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
| BG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
| BG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses |
| BG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| ERQ Reappraisal Score | Emotion Regulation Questionnaire (ERQ). The ERQ (6) is a 10-item self-report inventory that assesses the routine use of two cognitive emotion regulation strategies: expressive suppression and cognitive reappraisal. The items use a 7-point Likert scale with responses ranging from one (strongly disagree) to 7 (strongly agree). The data reported here is for the Cognitive reappraisal subscale which can range from 1 to 7, with higher scores indicating more use of reappraisal to alter emotions. | Mean | Standard Deviation | units on a scale |
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| DERS Total Score | Difficulties in Emotion Regulation Scale (DERS). The DERS (49) is a 36-item self-report measure of individuals' typical levels of emotion dysregulation across six domains. Participants respond on a Likert scale ranging from 1 (almost never) to 5 (almost always). The total score ranges from 36 to 180 with higher scores indicating higher dysregulation than lower scores. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time to Return to Heart Rate Baseline During the Regulation Period During Training | The estimated marginal mean of the difference in length of time that it takes participants to reduce emotional arousal after three emotional inductions when they use Cognitive Restructuring (CR) with or without the enhancing effects of transcranial magnetic stimulation (TMS). Psychophysiological measurements were collected continuously using the BIOPAC MP-150. For each baseline, heart rate (HR) was averaged from the last 240s. Time to return to one's HR baseline was defined as the amount of time (e.g., number of seconds) it took from the beginning of regulation for the continuously monitored HR to reach a value that was lower than the average pre-stimulus baseline HR. Lower numbers indicate quicker regulation (desirable outcome). A baseline value for regulation duration was computed as the time it took during habituation for the person to return to HR baseline. Number of seconds was transformed with a logarithmic function for analyses to achieve normality. | Each participant went through three stressor-regulation periods during the intervention. Only those who stressed at least during one of the three stressor periods were included in this analysis. Missing participants from the total ITT sample did not stress at all during the intervention stressor tasks. The results presented are estimated marginal means from the MMANOVA analysis that included this information | Posted | Least Squares Mean | Standard Error | log (seconds) | 1 week after intake |
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| Primary | Time to Return to Heart Rate Baseline During the Regulation Period at Follow up | The investigators will examine difference in length of time that it takes participants to reduce emotional arousal (as measured with physiological indicators) after an emotional induction when they use CR. This measure, was collected at the 1 month follow up assessment. Only one stressor-regulation period was presented at follow up. The number of seconds it took for participants to return to the pre-stimulus baseline during the regulation period was transformed with a log function for normality. Lower numbers indicate quicker regulation, a desirable outcome. | only participants who "stressed" during the follow up stressor task (i.e., their heart rate was above baseline at the beginning of the follow up regulation period) were included in these analyses. Missing participants did not stress at follow up. | Posted | Mean | Standard Error | log (seconds) | 1 month |
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| Primary | Physiological Emotion Regulation | The investigators will record heart rate continuously throughout the intervention and then extract high frequency heart rate variability (an index of emotion regulation) from the regulation periods. Continuously recorded HR was divided into 120 s bins, and HF-HRV was extracted from cleaned raw ECG from each bin. Baseline HF-HRV was measured at the beginning of the experiment and right before each autobiographical stressor presentation. The treatment condition (active left, active right, or sham), baselines, the experimental condition (regulation 1, 2, and 3), and the time within each experimental condition (0 to 4 for each 120 s segment within that period) were used to predict HF-HRV. Higher HF-HRV indicates enhanced regulation, a desirable outcome. To make interpretation easier, the raw HF-HRV score was multiplied with 1000000. To achieve normality, this multiplied score was transformed with a logarithmic function. | Posted | Least Squares Mean | Standard Error | lg(1000000*milliseconds) | 1 week after study start |
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| Primary | Changes in Activation in the Neural Emotion Regulation Network | For groups 4 &5, the investigators collected functional imaging data while participants engaged in an emotion regulation task. We examined the BOLD response change in the contrast between down-regulating negative emotions and feeling negative emotions a week after intervention controlling for the maximum change in this contrast at intake. Specifically we examined changes in activation in the dorsolateral prefrontal cortex (dlPFC), ventrolateral PFC (vlPFC), ventromedial PFC (vmPFC), the amygdala and insula. Data were first preprocessed with fMRIprep and MRIQC. At the first level, functional data were analyzed as individual runs, using a general linear model (GLM) in which trial events were convolved with a double-gamma hemodynamic response function. The [Restructure- Feel_negative] contrast was then used to generate Level 2 analysis, in which BOLD activity for each of the four runs were combined using a fixed-effect model. Higher numbers indicate more activation (desired outcome). | This data was not collected from all participants. It was only collected for a subset of participants assigned to the imaging sub study (groups 4 and 5). The numbers presented represent estimated marginal means from the MANCOVA analysis comparing conditions and covarying maximum activation within the contrast at intake. | Posted | Least Squares Mean | Standard Error | Maximum % signal change in ROI | 1 week |
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| Secondary | Acceptability, as Measured by Qualitative Exit Interview | The investigators will examine how acceptable participants find the intervention. A previously developed in-house interview (A. D. Neacsiu, Luber, et al., 2018) was administered at the 1-month follow up, and it included Likert-type questions about feasibility, acceptability, and overall satisfaction rated on a scale from 0 (not at all) to 9 (extremely; secondary outcomes). | Only participants who were not lost to contact by the last session of the study provided data for this outcome measure. One participant did not complete the acceptability portion of the exit interview and as a result their data cannot be included. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Feasibility, as Measured by Qualitative Exit Interview | The investigators will examine how feasible the proposed intervention is. A previously developed in-house interview (A. D. Neacsiu, Luber, et al., 2018) was administered at the 1-month follow up, and it included Likert-type questions about feasibility, acceptability, and overall satisfaction rated on a scale from 0 (not at all) to 9 (extremely; secondary outcomes). | Only participants who were not lost to contact by the last study session provided data for this analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Change in General Psychological Distress, as Measured by the Outcome Questionaire -45 | The investigators will examine change in general psychological distress after the intervention. The Outcome Questionnaire-45 (OQ-45) is a 45-item self-report measure used to track severity of psychopathology throughout treatment. It consists of subscales that identify three types of problems that lead to general stress: psychological symptoms, interpersonal conflicts, and problems with social roles. Items are rated on a Likert scale ranging from 0 (never) to 4 (almost always). We computed the total score (ranging from 0 to 180) from data collected at intake, at 1 week after the intervention, and at 1 month after the intervention. Higher score indicate higher psychopathological distress than lower scores. The estimated marginal means from the growth model comparing differences between conditions are presented in the table below. | Only participants who provided data were included. In the first study (first 3 groups) one participant from the active right condition did not complete the 1-week follow-up self-reports. One sham, three active left, and one active right participant could not tolerate the intervention and dropped. In the second study (last 2 groups) two participants could not tolerate the intervention and dropped in each condition. One participant in sham did not complete his OQ-45 measure at follow up. | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week and 1 month |
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| Secondary | Change in Daily General Emotional Distress | The investigators will examine change in emotional distress after the intervention as measured by daily mobile phone ratings 8 times/day for 7 days of subjective units of distress; SUDS). The 8 ratings/day will then be averaged into a mean/day. This daily SUDS mean (range 0-9) will be entered in analyses. Higher SUDS indicates more distress. | Posted | Least Squares Mean | Standard Error | units on a scale per day | 1 week |
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| Secondary | Change in Emotion Dysregulation and Functional Impairment | The investigators will examine changes in the reappraisal scale of the Emotion Regulation Questionnaire (ERQ; range 1-7), in the total score from the Difficulties with Emotion Regulation Scale (DERS; range 36-180), and in the total score from the work and social adjustment functional impairment scale (WSAS; range 0-40) from before to after the one time intervention. Higher ERQ-Reappraisal scores indicate more use of cognitive restructuring (a favorable outcome). Lower DERS total score and lower WSAS average score indicate lower overall emotional dysregulation and lower impairment in functioning, which are desirable outcomes. Outcomes were analyzed using HLM models and the data presented below represents the estimate marginal means for each condition for the growth in each outcome controlling for baseline. | Only participants who provided data were included. In the first study (first 3 groups) one participant from the active right condition did not complete the 1-week follow-up self-reports. One sham, three active left, and one active right participant could not tolerate the intervention and dropped. In the second study (last 2 groups) two participants could not tolerate the intervention and dropped in each condition. One participant in sham did not complete his self-report measures at follow up. | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week and 1 month after the intervention |
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Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Restructuring+rTMS (Left) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. | 0 | 14 | 0 | 14 | 9 | 14 |
| EG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. | 0 | 15 | 0 | 15 | 6 | 15 |
| EG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. | 0 | 18 | 0 | 18 | 10 | 18 |
| EG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. | 0 | 16 | 0 | 16 | 9 | 16 |
| EG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. | 0 | 15 | 0 | 15 | 5 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Manic like mood | Psychiatric disorders | Non-systematic Assessment | right after neurostimulation felt good and slept about 8 hours that night. The next day began feeling more euphoric and had difficulty sleeping for the next 5 nights. She reported increased goal directed activity, and racing thoughts. |
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| Scalp Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Panic Attack | Psychiatric disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Increased Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Presyncopal episode | Nervous system disorders | Non-systematic Assessment |
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| mild hearing impairment | Ear and labyrinth disorders | Non-systematic Assessment | before intervention reported no hearing impairment but post reported mild temporary hearing impairment. |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrada D. Neacsiu | Duke University Health System | 919-684-6714 | andrada.neacsiu@duke.edu |
| Feb 8, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2019 | Feb 8, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D010554 | Personality Disorders |
| D000068099 | Trauma and Stressor Related Disorders |
| D003193 | Compulsive Personality Disorder |
| D001068 | Feeding and Eating Disorders |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000088686 | Cognitive Restructuring |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015). |
| A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors. | Mixed Models Analysis | .08 | Mean Difference (Net) | .237 | Standard Error of the Mean | .133 | 2-Sided | 95 | -.034 | .508 | Superiority |
| Regulation duration was transformed using a logarithmic transformation to achieve normality | Mixed Models Analysis | we controlled for baseline and for the distance between the brain and the scalp | .033 | A priori threshold for significance was set to .05. | Mean Difference (Net) | -.227 | Standard Error of the Mean | .103 | 2-Sided | 95 | -.434 | -.020 | Superiority |
| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
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| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses. (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses. (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
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| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
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|
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| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
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| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
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| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
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Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses. (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses. (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. |
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| OG001 | Cognitive Restructuring + Sham rTMS | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation. |
| OG002 | Cognitive Restructuring+rTMS (Right) | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements). Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG003 | Cognitive Restructuring+rTMS (Left) With Functional Targeting | Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting. rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring. |
| OG004 | Cognitive Restructuring + Sham rTMS With Functional Targeting | Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data. Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation. |
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