Teachers College, Columbia University
New York, 10027, United States
Location status: Recruiting
NCT Number: NCT07478393
This study is an open trial designed to examine individual changes that occur before, during, and after 6 modules of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
New York, 10027, United States
Location status: Recruiting
The main questions this study aims to answer are to:
Participants will:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Emotion Regulation Therapy (ERT)
Time frame: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)
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.
Time frame: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)
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.
Time frame: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
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.
Time frame: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)
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.
Time frame: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)
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.
Time frame: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
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.
Time frame: Baseline, 1st Treatment Session, Follow-Up (4 weeks)
The Behavior Dysregulation Scale (BDRS) is a 9-item self-report measure of behavioral emotion dysregulation.
Contact information is provided by the study sponsor or research team.
Douglas S Mennin
CONTACT
Moises Hernandez
CONTACT
Teachers College, Columbia University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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