Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH112705-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Many patients with Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder (gSAD) are treated with cognitive behavioral therapy (CBT) but few have meaningful improvement. MDD and gSAD are diseases of brain dysfunction that manifest as impaired emotion regulation; CBT teaches emotion regulation strategies but how it works in the brain remains largely unknown. Individual differences in brain function related to emotion regulation may make some patients better suited for CBT and CBT may remedy the brain dysfunction that underlies these disorders. This project will compare CBT with a placebo psychotherapy (i.e., supportive therapy) in MDD and gSAD to test, validate, and refine brain-based markers and examine mechanisms of change to examine how CBT works and for whom.
Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder (gSAD) are pervasive major public health problems. These disorders are characterized by emotion dysregulation, an inability or inefficiency to regulate negative and positive affect as reflected in common and disorder-specific symptoms (e.g., attentional bias to negative stimuli, excessive/inappropriate negative thoughts, hyperarousal, anhedonia, emotional blunting). Such dysregulation is believed to result from an imbalance between top-down 'emotion regulating' (ER) frontal nodes central in inhibitory control of bottom-up subcortical 'emotion-generating' (EG) nodes in a Fronto-Limbic Affect Regulation and Emotional Salience (FLARES) network. Therefore, successful treatment would be expected to 'normalize' neurofunctional disturbances in the FLARES network, which can be measured with fMRI and more distal units of brain function -- event-related potentials (ERPs) from electroencephalography, startle potentiation from electromyography (EMG), neurocognitive performance, and use of regulation strategies in daily life via self-report. The overarching objective of the proposed study is to understand how, when, and where CBT works and for whom to tailor treatment to improve clinical outcome.
Without precisely identified "targets" and "predictors" of change, CBT response will continue to be unpredictably varied with few achieving meaningful clinical improvement placing them at risk for relapse and recurrence. Our proposal builds on published data from our lab and others and Preliminary Data which shows FLARES function, as assayed with fMRI, ERPs, EMG, and behaviors, is sensitive to change following CBT.
Importantly, both baseline fMRI and non-fMRI units of brain-behavioral measures predict CBT response better than baseline clinical measures. Such knowledge can lead to more precise interventions aimed at capitalizing on 'strengths' or improving 'deficits' that may each exist before CBT and/or explain why CBT does not work for some patients. The dual development of fMRI ('mechanistic') and non-fMRI ('pragmatic') predictors and indices of therapeutic change is aimed at advancing precision medicine while increasing the clinical utility of 'biomarkers' in the outpatient setting. With this objective, we propose to employ well-validated paradigms to test ER and EG in the context of negative stimuli, reward processes, and fear systems in MDD and gSAD to delineate common and disorder-specific mechanisms of change and predictors of CBT outcome. We will enroll 200 patients: 100 MDD (without comorbid gSAD), 100 gSAD (without comorbid MDD) and randomize them to 12 weeks of manualized CBT or 12 weeks of 'placebo' psychotherapy (supportive therapy) (1:1 ratio). Multiple units of FLARES function will be collected in all patients before (Week 0), during (midway/Week 6) and after treatment (Week 12) to ascertain CBT 'dose' effects, and in 40 healthy controls for comparison. Pre-CBT predictors based on binary (responder/non-responder status) and continuous (extent of change) outcomes will be examined midway (Week 6), immediately after treatment (Week 12), and at 6-month follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT | Active Comparator | The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention. |
|
| ST | Placebo Comparator | The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms | Patients were randomized to either 12 weeks of cognitive behavioral therapy or supportive therapy. Healthy control (HC) participants did not receive treatment but completed the same assessments at the same time points as patients. Liebowitz Social Anxiety Scale (LSAS) and Hamilton Depression Rating Scale (HDRS) served as primary outcome measures as they are interviewer based standard clinical measures. A composite score combining LSAS and HDRS was constructed using proportion of maximum scaling (POMS) method to represent symptom severity. Higher scores mean worse outcomes. The minimum value is 0 and the maximum value is 1. | baseline and week 12 |
| Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients | Outcomes are parameter estimates (arbitrary units) of brain activity for a priori brain regions of interest (bilateral amygdala, bilateral dorsolateral prefrontal cortex ('DLPFC'), bilateral inferior frontal gyrus ('IFG')) comparing brain activity during task conditions against a baseline condition (look at neutral images; 'Look Neut'). Task conditions are reappraising negative images ('Reappraise') and looking at negative images ('Look Neg'). The Reappraise vs. Look Neut and Look Neg vs. Look Neut are the contrasts of interest. Not all participants who consented to the study completed this task at all time points. Reasons include dropping out of the study, COVID shutdowns, scheduling issues, and participants not consenting to perform task due to use of negative images. Higher values represent greater activation. | baseline |
| Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks). | Planned comparisons (i.e., paired t-test). Outcomes are parameter estimates (arbitrary units) of brain activity for a priori brain regions (amygdala, dorsolateral prefrontal cortex (DLPFC), inferior frontal gyrus (IFG)) comparing reappraising negative images ('Reappraise') to baseline condition (look at neutral images; 'Look Neut'). Not all participants who consented to the study completed this task at all time points. Reasons include dropping out of the study, COVID shutdowns, scheduling issues, and participants not consenting to perform task due to use of negative images. Higher values represent greater activation. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
For healthy controls: history or current Axis I disorder.
Additional exclusion criteria for all participants pertaining to the fMRI scan include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heide Klumpp, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34718341 | Derived | Feurer C, Jimmy J, Bhaumik R, Duffecy J, Medrano GR, Ajilore O, Shankman SA, Langenecker SA, Craske MG, Phan KL, Klumpp H. Anterior cingulate cortex activation during attentional control as a transdiagnostic marker of psychotherapy response: a randomized clinical trial. Neuropsychopharmacology. 2022 Jun;47(7):1350-1357. doi: 10.1038/s41386-021-01211-2. Epub 2021 Oct 30. |
Not provided
Not provided
35 participants consented to the study (included in protocol enrollment) but were not randomized due to study ineligibility or early withdrawal from the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy (CBT) | The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention. CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems. |
| FG001 | Supportive Therapy (ST) | The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT. ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance |
| FG002 | Control | Over a 12-week period, the control group will not receive treatment. Controls will do complete EEG, MRI, and Neuropsychological assessments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of all participants for whom baseline characteristics were measured, in each arm/group and in the entire study population (total).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Over a 12-week period, the control group will not receive treatment. Controls will do complete EEG, MRI, and Neuropsychological assessments. |
| BG001 | Supportive Therapy (ST) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms | Patients were randomized to either 12 weeks of cognitive behavioral therapy or supportive therapy. Healthy control (HC) participants did not receive treatment but completed the same assessments at the same time points as patients. Liebowitz Social Anxiety Scale (LSAS) and Hamilton Depression Rating Scale (HDRS) served as primary outcome measures as they are interviewer based standard clinical measures. A composite score combining LSAS and HDRS was constructed using proportion of maximum scaling (POMS) method to represent symptom severity. Higher scores mean worse outcomes. The minimum value is 0 and the maximum value is 1. | Only participants who completed the entire study (with data at baseline and week 12) were included. | Posted | Mean | Standard Deviation | units on a scale | baseline and week 12 |
|
The Adverse Event data was collected over the course of the 15 weeks of participating in the research study. Regardless of the treatment arm, the patient participants were randomized to, adverse events were collected for every lab visit (EEG/MRI/Neuropsych evaluation) CBT/ST sessions, and a 6-month follow-up.
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 Behavioral Therapy (CBT) | The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention. CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Event | Investigations | Non-systematic Assessment | Mild Other Adverse Events collected at participant lab visits |
Not all participants completed all tasks at all time points for various reasons (e.g., attrition), which reduced power to test hypotheses. During COVID shutdowns, psychotherapy sessions changed from in-person to secure telehealth. COVID shutdowns interfered with data collection, particularly in the lab (e.g., fMRI). Analytic approaches used in ClinicalTrials.gov may not reflect approaches used in published results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heide Klumpp, PhD | University of Illinois at Chicago | 312-996-0416 | hklumpp@uic.edu |
Not provided
| 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 | Jan 20, 2021 | Mar 17, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| ST | Behavioral | Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance |
|
|
| baseline and 12 weeks |
| Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm. | Outcomes are baseline parameter estimates (arbitrary units) of brain activity for a priori brain regions of interest (bilateral amygdala, bilateral dorsolateral prefrontal cortex ('DLPFC'), bilateral inferior frontal gyrus ('IFG')) comparing active conditions against 'baseline' condition (i.e., look at neutral images; 'Look Neut'). Active conditions are reappraising negative images ('Reappraise') and looking at negative images ('Look Neg'). The Reappraise vs. Look Neut and Look Neg vs. Look Neut are the contrasts of interest. Other outcome measure is symptom severity before and after psychotherapy collapsing across cognitive behavioral therapy and supportive therapy to examine general psychotherapy predictors across psychotherapies. Higher values (arbitrary units) represent greater activation. Aim 5 is a continuation of Aim 4 including symptom measures comprised of HAMD and LSAS composite score of maximum scaling method. | baseline |
| Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm. | This aim is connected to Aim 4 and represents an additional predictor in the regression model. Data analysis results for Aim 4 apply to this data as well. Outcome measure is symptom severity before and after psychotherapy collapsing across cognitive behavioral therapy and supportive therapy. Symptom measures comprised social anxiety (LSAS) and depression (HAMD) composite score proportion of maximum scaling method which ranges from 0 to 1. Higher symptom severity scores represent worse symptoms. | baseline and 12 weeks |
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
| BG002 | Cognitive Behavioral Therapy (CBT) | The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention. CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 1 CBT participant did not report their sex/gender identity | 1 CBT participant did not report their sex/gender identity so they are not included in the count. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Principal Diagnoses | Principal Diagnoses of participants in either treatment arm (ST and CBT) | Only counting participant in the treatment receiving arms (ST and CBT) | Count of Participants | Participants |
|
Healthy control participants did not receive treatment.
| OG001 | Cognitive Behavioral Therapy | The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention. CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems. |
| OG002 | Supportive Therapy | The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT. ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance |
|
|
|
| Primary | Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients | Outcomes are parameter estimates (arbitrary units) of brain activity for a priori brain regions of interest (bilateral amygdala, bilateral dorsolateral prefrontal cortex ('DLPFC'), bilateral inferior frontal gyrus ('IFG')) comparing brain activity during task conditions against a baseline condition (look at neutral images; 'Look Neut'). Task conditions are reappraising negative images ('Reappraise') and looking at negative images ('Look Neg'). The Reappraise vs. Look Neut and Look Neg vs. Look Neut are the contrasts of interest. Not all participants who consented to the study completed this task at all time points. Reasons include dropping out of the study, COVID shutdowns, scheduling issues, and participants not consenting to perform task due to use of negative images. Higher values represent greater activation. | Primary outcomes did not include hypotheses related to differences between treatment arms (cognitive behavioral therapy, supportive therapy); therefore, analyses were collapsed across treatment arms. | Posted | Mean | Standard Deviation | arbitrary units | baseline |
|
|
|
|
| Primary | Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks). | Planned comparisons (i.e., paired t-test). Outcomes are parameter estimates (arbitrary units) of brain activity for a priori brain regions (amygdala, dorsolateral prefrontal cortex (DLPFC), inferior frontal gyrus (IFG)) comparing reappraising negative images ('Reappraise') to baseline condition (look at neutral images; 'Look Neut'). Not all participants who consented to the study completed this task at all time points. Reasons include dropping out of the study, COVID shutdowns, scheduling issues, and participants not consenting to perform task due to use of negative images. Higher values represent greater activation. | Participants included both participants with major depression and social anxiety. Primary outcomes did not include hypotheses related to differences between diagnostic groups; therefore, statistical analyses were collapsed across diagnostic groups. | Posted | Mean | Standard Deviation | arbitrary units | baseline and 12 weeks |
|
|
|
|
| Primary | Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm. | Outcomes are baseline parameter estimates (arbitrary units) of brain activity for a priori brain regions of interest (bilateral amygdala, bilateral dorsolateral prefrontal cortex ('DLPFC'), bilateral inferior frontal gyrus ('IFG')) comparing active conditions against 'baseline' condition (i.e., look at neutral images; 'Look Neut'). Active conditions are reappraising negative images ('Reappraise') and looking at negative images ('Look Neg'). The Reappraise vs. Look Neut and Look Neg vs. Look Neut are the contrasts of interest. Other outcome measure is symptom severity before and after psychotherapy collapsing across cognitive behavioral therapy and supportive therapy to examine general psychotherapy predictors across psychotherapies. Higher values (arbitrary units) represent greater activation. Aim 5 is a continuation of Aim 4 including symptom measures comprised of HAMD and LSAS composite score of maximum scaling method. | Primary outcomes did not include hypotheses related to differences between treatment arms (cognitive behavioral therapy and supportive therapy); therefore, analyses were collapsed across treatment arms and only included those who completed therapy in order to examine possible general psychotherapy predictors. | Posted | Mean | Standard Deviation | arbitrary units | baseline |
|
|
|
|
| Primary | Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm. | This aim is connected to Aim 4 and represents an additional predictor in the regression model. Data analysis results for Aim 4 apply to this data as well. Outcome measure is symptom severity before and after psychotherapy collapsing across cognitive behavioral therapy and supportive therapy. Symptom measures comprised social anxiety (LSAS) and depression (HAMD) composite score proportion of maximum scaling method which ranges from 0 to 1. Higher symptom severity scores represent worse symptoms. | Primary outcomes did not include hypotheses related to differences between treatment arms (cognitive behavioral therapy and supportive therapy); therefore, analyses were collapsed across treatment arms and only included those who completed therapy in order to examine general psychotherapy predictors. | Posted | Mean | Standard Deviation | proportion of maximum scaling | baseline and 12 weeks |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 32 |
| 61 |
| EG001 | Supportive Therapy (ST) | The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT. ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance | 0 | 57 | 0 | 57 | 25 | 57 |
| EG002 | Control | Over a 12-week period, the control group will not receive treatment. Controls will complete EEG, MRI, and Neuropsychological assessments. | 0 | 50 | 0 | 50 | 4 | 50 |
|
| Other Adverse Event | Investigations | Non-systematic Assessment | Mild passive suicidal ideation for participants during all visits |
|
Not provided
Not provided
Not provided
| D001008 |
| Anxiety Disorders |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Between 18 and 65 years |
|
| >=65 years |
|
| 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 |
|
| SAD Primary Diagnosis |
|
|
| left DLPFC; Reappraise vs. Look Neut |
|
| right DLPFC; Reappraise vs. Look Neut |
|
| left IFG; Reppraise vs. Look Neut |
|
| right IFG; Reappraise vs. Look Neut |
|
|
| Baseline right amygdala; reappraise vs. look neut |
|
| Week 12 right amygdala; reappraise vs. look neut |
|
| Baseline left DLPFC; reappraise vs. look neut |
|
| Week 12 left DLPFC; reappraise vs. look neut |
|
| Baseline right DLPFC; reappraise vs. look neut |
|
| Week 12 right DLPFC; reappraise vs. look neut |
|
| Baseline left IFG; reappraise vs. look neut |
|
| Week 12 left IFG; reappraise vs. look neut |
|
| Baseline right IFG; reappraise vs. look neut |
|
| Week 12 right IFG; reappraise vs. look neut |
|
Planned comparisons are paired t-tests for cognitive behavioral therapy (CBT) or supportive therapy (ST)
| left DLPFC; Reappraise vs. Look Neut |
|
| right DLPFC; Reappraise vs. Look Neut |
|
| left IFG; Reappraise vs. Look Neut |
|
| right IFG; Reappraise vs. Look Neut |
|
| left amygdala; Look Neg vs. Look Neut |
|
| right amygdala; Look Neg vs. Look Neut |
|
| left DLPFC; Look Neg vs. Look Neut |
|
| right DLPFC; Look Neg vs. Look Neut |
|
| left IFG; Look Neg vs. Look Neut |
|
| right IFG; Look Neg vs. Look Neut |
|