An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy

Depression Clinical Trial

Official title:

An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy: A Multiple Case-Based Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05590741
• Other study ID #: 23-008
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The main questions this study aims to answer are to:

1. Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.

2. Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.

3. Demonstrate the preliminary efficacy of a 12-session version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.

Participants will:

1. Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare

2. Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College

3. Attend 12 once-weekly telehealth ERT sessions

4. Complete 18 weekly questionnaires online via Qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: November 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

• High self-reported worry, rumination, and/or self-criticism

• Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder

Exclusion Criteria:

• 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

• Current students at Teachers College, Columbia University

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress, Emotional
• Rumination
• Self-Criticism
• Worry

Intervention

Behavioral:
• Emotion Regulation Therapy via Telehealth
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).

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)