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| Name | Class |
|---|---|
| Kent State University | OTHER |
| Weill Medical College of Cornell University | OTHER |
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The present project aims to broaden our understanding of neural mechanisms which may underlie change in symptoms occurring over the course of Emotion Regulation Therapy. Specifically, we aim to examine neural changes as a result of either an 8-session or 16-session version of the treatment.
This study aims to examine the utility of Emotion Regulation Training (ERT) in reducing symptoms of anxiety and/or depression in young adults aged 18 to 29 years old. Additionally, we are interested in assessing neural, cardiac, and immunological changes associated with psychological symptom reduction in these individuals. Lastly, we are interested in examining whether an abbreviated 8-session version of ERT produces similar results to a longer (16-session) version of ERT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotion Regulation Therapy: 8-session version | Experimental | All participants will be randomly assigned to an 8-session or 16-session version of ERT with equal probability. Participants assigned to the 8-session version of ERT will receive 8 sessions of individualized therapy, each of which is 1-1.5 hours, on a weekly basis. Sessions 1-5 will be 1 hour long, sessions 6 and 7 will be 1.5 hours long, and session 8 will be one hour long, resulting in a total required time commitment of 9 hours over the course of 8 weeks. |
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| Emotion Regulation Therapy: 16-session version | Experimental | All participants will be randomly assigned to an 8-session or 16-session version of ERT with equal probability. Participants assigned to the 16-session version of ERT will receive 16 sessions of individualized therapy, each of which is 1-1.5 hours, on a weekly basis. Sessions 1-9 will be 1 hour long, sessions 10-13 will be 1.5 hours long, and sessions 14-16 will be 1 hour long, resulting in a total required time commitment of 18 hours over the course of 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotion Regulation Therapy: 8-session version | Behavioral | Emotion Regulation Therapy will be administered over 8 individual sessions on a weekly basis, resulting in a total required time commitment of 9 hours over the course of 8 weeks. The initial stage of treatment focuses on psychoeducation about anxiety and depression, individual patterns of these behaviors, emotions in recent situations, and self-monitoring of worry, anxiety, and depression. The sessions focus on the development of skills that help regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, and soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining sessions focus on terminating therapy, relapse prevention, and future goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Worry | Penn State Worry Questionnaire (PSWQ) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Changes in Rumination | Rumination-Reflection Questionnaire (RRQ) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Changes in Functional Impairment | Sheehan Disability Scale (SDS) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Changes in Life Satisfaction | Quality of Life Inventory (QOLI) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Changes in Diagnostic Criteria, Severity, and Improvement | Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Anxiety and Depression | Mood and Anxiety Symptom Questionnaire (MASQ) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Model-Related Changes: Attention Regulation |
| Measure | Description | Time Frame |
|---|---|---|
| Neural Changes using fMRI | Resting State and Behavioral Tasks (i.e., Attentional Shifting Task, Emotion Regulation Task, Approach-Avoidance Conflict Task) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment) |
| Cardiac Changes using HRV |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teachers College, Columbia University | New York | New York | 10027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29504794 | Result | Mennin DS, Fresco DM, O'Toole MS, Heimberg RG. A randomized controlled trial of emotion regulation therapy for generalized anxiety disorder with and without co-occurring depression. J Consult Clin Psychol. 2018 Mar;86(3):268-281. doi: 10.1037/ccp0000289. | |
| 29704969 | Result | Renna ME, Quintero JM, Soffer A, Pino M, Ader L, Fresco DM, Mennin DS. A Pilot Study of Emotion Regulation Therapy for Generalized Anxiety and Depression: Findings From a Diverse Sample of Young Adults. Behav Ther. 2018 May;49(3):403-418. doi: 10.1016/j.beth.2017.09.001. Epub 2017 Sep 8. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000098647 | Generalized Anxiety Disorder |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068356 | Self-Control |
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All participants will be randomly assigned to an 8-session or 16-session version of ERT.
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| Emotion Regulation Therapy: 16-session version | Behavioral | Emotion Regulation Therapy will be administered over 16 individual sessions on a weekly basis, resulting in a total required time commitment of 18 hours over the course of 16 weeks. The initial stage of treatment focuses on psychoeducation about anxiety and depression, individual patterns of these behaviors, emotions in recent situations, and self-monitoring of worry, anxiety, and depression. The sessions focus on the development of skills that help regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, and soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining sessions focus on terminating therapy, relapse prevention, and future goals. |
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Attentional Control Scale (ACS) |
| Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Model-Related Changes: Metacognitive Regulation | Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ) | Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
Resting State |
| Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up |
| Inflammatory Markers | Blood Draw (i.e., IL-6, TNF-alpha, and the C-reactive protein) | Pre-Treatment, Post-Treatment (either 8- or 16- weeks after starting treatment) |
| 28220089 | Result | Renna ME, Quintero JM, Fresco DM, Mennin DS. Emotion Regulation Therapy: A Mechanism-Targeted Treatment for Disorders of Distress. Front Psychol. 2017 Feb 6;8:98. doi: 10.3389/fpsyg.2017.00098. eCollection 2017. |
| 39491310 | Derived | Renna ME, Spaeth PE, Quintero JM, O'Toole MS, Sandman CF, Fresco DM, Mennin DS. A randomized controlled trial comparing two doses of emotion regulation therapy: Preliminary evidence that gains in attentional and metacognitive regulation reduce worry, rumination, and distress. Behav Res Ther. 2023 Oct 21;170:104420. doi: 10.1016/j.brat.2023.104420. Online ahead of print. |
| D012919 |
| Social Behavior |