An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety; Distress, Emotional; Rumination; Self-Criticism; Worry
• Intervention / Treatment: Behavioral: Emotion Regulation Therapy via Telehealth

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Teachers College, Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; 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.

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).; Other Names: Emotion Regulation Therapy (ERT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Teachers College, Columbia University
• Investigators: Principal Investigator: Douglas S Mennin, Professor of Clinical Psychology

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Emotion Regulation; Rumination; Worry; Emotion Regulation Therapy; Self-Criticism; Treatment Mechanisms
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Feeding and Eating Disorders; Gastrointestinal Diseases; Rumination Syndrome
• Other Study ID Numbers: 23-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No