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This study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.
The main questions this study aims to answer are to:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All participants will receive a 12-session version of Emotion Regulation Therapy delivered weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based online platform to supplement the content covered in each session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotion Regulation Therapy via Telehealth | Behavioral | The initial stage of treatment focuses on psychoeducation about anxiety/depression, the impact that these cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/anxiety/depression. The sessions focus on the development of skills that help understand and regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, 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 session focuses on terminating therapy, relapse prevention, and future goals. An Internet-based online platform will be used to promote engagement with and increase accessibility to between-session skills practice and treatment-related activities (e.g., self-monitoring, session summaries, worksheets). |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Assessment of Change in Attentional Control | The Attentional Control Scale (ACS) is a 21-item measure used to measure difficulties with concentration associated with problems regulating emotions. The focusing and shifting subscales of the ACS align with the two attention emotion regulation (ER) skills taught in ERT. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Decentering | The decentering subscale of the Experiences Questionnaire (EQ-D) is an 11-item subscale assessing one's ability to distance themselves from their emotional experience, which is one metacognitive ER skill taught during ERT. Higher scores on this subscale indicate better ability to distancing oneself from one's emotional experience. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Reappraisal | The reappraisal subscale of the Emotion Regulation Questionnaire (ERQ) is a 6-item measure of the ability to regulate emotions, using the strategy of reappraisal. Higher scores on this subscale indicate a better ability to regulate emotions using the strategy of reappraisal. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Valued Living/Action | The Valuing Questionnaire (VQ) is a 10-item measure of the degree to which patients live by their values in daily life. It uses a 7-point Likert scale (0-6) to assess progress and obstructions to valued living. Higher scores on this measure indicate more valued living. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Assessment of Change in Depression Severity | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Emotional Distress - Depression - Short Form 8a will be administered to assess for depression severity. Higher scores on this measure indicate greater depression severity. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Assessment of Change in Disability/Impairment | The Sheehan Disability Scale (SDS) is a 4-item scale which assesses impairment in work, social life/leisure activity, family life/home responsibilities, and overall functioning. Higher scores on this measure indicate greater impairment. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas S Mennin | Professor of Clinical Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teachers College, Columbia University | New York | New York | 10027 | United States |
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| ID | Term |
|---|---|
| D000079562 | Rumination Syndrome |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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The Mental Representation of Approach Avoidance Questionnaire (MRAAQ) is a 42-item self-report assessment designed to capture the mental representation of approach-avoidance motivation.
| Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Anxiety Severity | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank - Emotional Distress - Anxiety - Short Form 8a will be administered to assess for anxiety severity. Higher scores on this measure indicate greater anxiety severity. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Rumination | The Rumination-Reflection Questionnaire (RRQ) is a 12-item measure that assesses past-focused rumination with specificity regarding the types of rumination that people may experience. Higher scores on this measure indicate greater rumination. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Worry | The Penn State Worry Questionnaire - Past Week (PSWQ-PW) is an adapted version of the original PSWQ, contains 15 items (rated on a 0-6 scale), and assesses the extent to which worry has been excessive, uncontrollable, and pervasive in the past week. Higher scores on this measure indicate greater worry in the past week. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Self-Criticism | The self-judgment subscale of the Self-Compassion Scale (SCS) contains 5-items and assesses the tendency to self-criticize. Higher scores on this measure indicate greater self-criticism. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Life Satisfaction | The Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) is a 5-item scale assessing a participant's satisfaction within a number of domains regarding their social and occupational functioning. Higher scores on this measure indicate greater life satisfaction. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| Weekly Assessment of Change in Behavioral Regulation | The Behavior Regulation Scale (BRS) is a 24-item self-report measure of behaviors engaged for the purposes of ER. | Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks) |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |