Readiness and Progress in Emotion Regulation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTeachers College, Columbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 18 and 65
Fluent in English (and therefore able to provide consent)
Currently living in New York State
Access to at least one device with internet and video-conferencing capabilities
Disqualifiers
Active suicidal ideation or intent
Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
Currently in therapy or receiving any type of psychosocial treatment
Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
Trial design
Design model
Single group
Treatments tested in this trial
Emotion Regulation Therapy via Telehealth
BehavioralThe 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).
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)2
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.
Time frame
Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)3
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.
Time frame
Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)4
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.
Time frame
Baseline, 1st Treatment Session, Follow-Up (4 weeks)Secondary outcomes
1
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.
Time frame
Baseline, 1st Treatment Session, Follow-Up (4 weeks)2
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.
Time frame
Baseline, 1st Treatment Session, Follow-Up (4 weeks)Other outcomes
1
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.
Time frame
Baseline, 1st Treatment Session, Follow-Up (4 weeks)2
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.
Time frame
Baseline, 1st Treatment Session, Follow-Up (4 weeks)3
Weekly Assessment of Change in Behavioral Dysregulation
The Behavior Dysregulation Scale (BDRS) is a 9-item self-report measure of behavioral emotion dysregulation.
Time frame
Baseline, 1st Treatment Session, Follow-Up (4 weeks)Sponsors and contacts
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Source ClinicalTrials.gov