An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy

NCT ID: NCT05590741

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2025-11-30

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.

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Emotion Regulation Therapy via Telehealth

Intervention Type: 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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Emotion Regulation Therapy (ERT)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teachers College, Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Douglas Mennin

Professor of Clinical Psychology, Director of Clinical Training

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas S Mennin

Role: PRINCIPAL_INVESTIGATOR

Professor of Clinical Psychology

Locations

Teachers College, Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

23-008

Identifier Type: -

Identifier Source: org_study_id