An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy

NCT05590741 | Active Not Recruiting

• 1 other identifier: 23-008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Worry; Rumination; Self-Criticism; Emotion Regulation Therapy; Emotion Regulation; Treatment Mechanisms

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Weekly Assessment of Change in Depression Severity

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

• Weekly Assessment of Change in Anxiety Severity

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

• Weekly Assessment of Change in Rumination

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

• Weekly Assessment of Change in Worry

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

• Weekly Assessment of Change in Self-Criticism

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

Other Outcomes (3)

• Weekly Assessment of Change in Disability/Impairment

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

• Weekly Assessment of Change in Life Satisfaction

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

• Weekly Assessment of Change in Behavioral Regulation

  Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)

Study Arms (1)

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.

Behavioral: Emotion Regulation Therapy via Telehealth

Interventions

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).

Also known as: Emotion Regulation Therapy (ERT)

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Rumination Syndrome; Anxiety Disorders; Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Douglas S Mennin

  Professor of Clinical Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology, Director of Clinical Training

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 21, 2022
• Study Start: November 16, 2022
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

US (1)