An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy

Sponsor
Teachers College, Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05590741
Collaborator
(none)
24
1
1
24
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotion Regulation Therapy via Telehealth
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy: A Multiple Case-Based Design
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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)
  • Outcome Measures

    Primary Outcome Measures

    1. Weekly Assessment of Change in Attentional Control [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    2. Weekly Assessment of Change in Decentering [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    3. Weekly Assessment of Change in Reappraisal [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    4. Weekly Assessment of Change in Valued Living/Action [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    5. Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    Secondary Outcome Measures

    1. Weekly Assessment of Change in Depression Severity [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    2. Weekly Assessment of Change in Anxiety Severity [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    3. Weekly Assessment of Change in Rumination [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    4. Weekly Assessment of Change in Worry [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    5. Weekly Assessment of Change in Self-Criticism [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    Other Outcome Measures

    1. Weekly Assessment of Change in Disability/Impairment [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    2. Weekly Assessment of Change in Life Satisfaction [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      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.

    3. Weekly Assessment of Change in Behavioral Regulation [Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)]

      The Behavior Regulation Scale (BRS) is a 24-item self-report measure of behaviors engaged for the purposes of ER.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teachers College, Columbia University New York New York United States 10027

    Sponsors and Collaborators

    • Teachers College, Columbia University

    Investigators

    • Principal Investigator: Douglas S Mennin, Professor of Clinical Psychology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Mennin, Professor of Clinical Psychology, Director of Clinical Training, Teachers College, Columbia University
    ClinicalTrials.gov Identifier:
    NCT05590741
    Other Study ID Numbers:
    • 23-008
    First Posted:
    Oct 21, 2022
    Last Update Posted:
    Nov 15, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Douglas Mennin, Professor of Clinical Psychology, Director of Clinical Training, Teachers College, Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2022