An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy
Primary Purpose
Rumination, Worry, Self-Criticism
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion Regulation Therapy via Telehealth
Sponsored by
About this trial
This is an interventional treatment trial for Rumination focused on measuring Worry, Rumination, Self-Criticism, Emotion Regulation Therapy, Emotion Regulation, Treatment Mechanisms
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
Sites / Locations
- Teachers College, Columbia UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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 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 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 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 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.
Secondary Outcome Measures
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 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 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 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 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.
Full Information
NCT ID
NCT05590741
First Posted
October 13, 2022
Last Updated
March 9, 2023
Sponsor
Teachers College, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT05590741
Brief Title
An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy
Official Title
An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy: A Multiple Case-Based Design
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teachers College, Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
The main questions this study aims to answer are to:
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.
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.
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:
Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare
Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College
Attend 12 once-weekly telehealth ERT sessions
Complete 18 weekly questionnaires online via Qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination, Worry, Self-Criticism, Anxiety, Depression, Distress, Emotional
Keywords
Worry, Rumination, Self-Criticism, Emotion Regulation Therapy, Emotion Regulation, Treatment Mechanisms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Therapy via Telehealth
Other Intervention Name(s)
Emotion Regulation Therapy (ERT)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Weekly Assessment of Change in Attentional Control
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Decentering
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Reappraisal
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Valued Living/Action
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Secondary Outcome Measure Information:
Title
Weekly Assessment of Change in Depression Severity
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Anxiety Severity
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Rumination
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Worry
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Self-Criticism
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Other Pre-specified Outcome Measures:
Title
Weekly Assessment of Change in Disability/Impairment
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Life Satisfaction
Description
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.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Title
Weekly Assessment of Change in Behavioral Regulation
Description
The Behavior Regulation Scale (BRS) is a 24-item self-report measure of behaviors engaged for the purposes of ER.
Time Frame
Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas S Mennin
Phone
212.678.6609
Email
mennin@tc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Szkutak
Phone
212.678.6609
Email
emotionregulationtherapy12@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas S Mennin
Organizational Affiliation
Professor of Clinical Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas S Mennin, PhD
Phone
212-678-6609
Email
mennin@tc.columbia.edu
12. IPD Sharing Statement
Learn more about this trial
An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy
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