Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic (ERT-P)
Primary Purpose
Distress, Emotional, Emotional Dysfunction, Anxiety
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion Regulation Training via Telehealth
Sponsored by
About this trial
This is an interventional treatment trial for Distress, Emotional focused on measuring Emotion Regulation, Distress Disorders, Anxiety, Depression, COVID-19 Pandemic, Telehealth
Eligibility Criteria
Inclusion Criteria:
- Aged 18-65 years during the time of participation
- Endorses distress and worry/rumination exacerbated by the COVID-19 pandemic
- Access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the Internet
Exclusion Criteria:
- Active suicidal intent
- Current substance dependence disorder (within the past year)
- Current or past psychotic disorder, Bipolar-I disorder, or dementia
- Primary DSM-5 diagnosis of borderline or narcissistic personality disorder
- Currently receiving any other form of psychosocial treatment
Sites / Locations
- Teachers College, Columbia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emotion Regulation Training via Telehealth
Arm Description
All participants will receive 9 sessions of Emotion Regulation Training delivered via telehealth. These individualized therapy sessions are 1-hour in length and occur semi-weekly over the course of four weeks.
Outcomes
Primary Outcome Measures
Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)
Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes)
Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)
Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes)
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes)
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes)
Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate better outcomes)
Secondary Outcome Measures
Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Semi-Weekly Measures of Treatment Changes in Depression Symptoms
Quick Inventory of Depressive Symptoms(QUIDS)
Semi-Weekly Measures of Treatment Changes in Distress
Distress Thermometer (DT)
Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)
Scale: 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)
Scale = 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)
Scale = 1-5 (minimum = 6; maximum = 30; higher scores indicate better outcomes)
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)
Scale = 1-5 (minimum = 5; maximum = 25; higher scores indicate better outcomes)
Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)
Scale = 1-4 (minimum = 6; maximum = 24; higher scores indicate better outcomes)
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
Scale = 1-4 (minimum = 4; maximum = 16; higher scores indicate better outcomes)
Full Information
NCT ID
NCT04615416
First Posted
October 26, 2020
Last Updated
June 10, 2022
Sponsor
Teachers College, Columbia University
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04615416
Brief Title
Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic
Acronym
ERT-P
Official Title
Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teachers College, Columbia University
Collaborators
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.
Detailed Description
The present study is evaluating whether this ERT treatment program delivered via telehealth demonstrates efficacy in: 1) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination); 2) improving outcomes specific to the ERT mechanism-based model (e.g., attentional control, decentering, reappraisal); 3) improving quality of life and functioning, for adults aged 18-65 years old.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Emotional, Emotional Dysfunction, Anxiety, Depression
Keywords
Emotion Regulation, Distress Disorders, Anxiety, Depression, COVID-19 Pandemic, Telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive a 9-session version of Emotion Regulation Training delivered semi-weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based Online platform to supplement the content covered in each session.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emotion Regulation Training via Telehealth
Arm Type
Experimental
Arm Description
All participants will receive 9 sessions of Emotion Regulation Training delivered via telehealth. These individualized therapy sessions are 1-hour in length and occur semi-weekly over the course of four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Training 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
Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)
Description
Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Title
Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)
Description
Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Title
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
Description
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Title
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
Description
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Title
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
Description
Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Title
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
Description
Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Title
Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
Description
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate better outcomes)
Time Frame
Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Secondary Outcome Measure Information:
Title
Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety
Description
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression
Description
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Depression Symptoms
Description
Quick Inventory of Depressive Symptoms(QUIDS)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Distress
Description
Distress Thermometer (DT)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)
Description
Scale: 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)
Description
Scale = 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)
Description
Scale = 1-5 (minimum = 6; maximum = 30; higher scores indicate better outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)
Description
Scale = 1-5 (minimum = 5; maximum = 25; higher scores indicate better outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)
Description
Scale = 1-4 (minimum = 6; maximum = 24; higher scores indicate better outcomes)
Time Frame
Semi-weekly over the course of four weeks
Title
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
Description
Scale = 1-4 (minimum = 4; maximum = 16; higher scores indicate better outcomes)
Time Frame
Post-Treatment (4-5 weeks after starting treatment)
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:
Aged 18-65 years during the time of participation
Endorses distress and worry/rumination exacerbated by the COVID-19 pandemic
Access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the Internet
Exclusion Criteria:
Active suicidal intent
Current substance dependence disorder (within the past year)
Current or past psychotic disorder, Bipolar-I disorder, or dementia
Primary DSM-5 diagnosis of borderline or narcissistic personality disorder
Currently receiving any other form of psychosocial treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas S Mennin, Ph.D.
Organizational Affiliation
Teachers College, Columbia University
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29504794
Citation
Mennin DS, Fresco DM, O'Toole MS, Heimberg RG. A randomized controlled trial of emotion regulation therapy for generalized anxiety disorder with and without co-occurring depression. J Consult Clin Psychol. 2018 Mar;86(3):268-281. doi: 10.1037/ccp0000289.
Results Reference
result
PubMed Identifier
29704969
Citation
Renna ME, Quintero JM, Soffer A, Pino M, Ader L, Fresco DM, Mennin DS. A Pilot Study of Emotion Regulation Therapy for Generalized Anxiety and Depression: Findings From a Diverse Sample of Young Adults. Behav Ther. 2018 May;49(3):403-418. doi: 10.1016/j.beth.2017.09.001. Epub 2017 Sep 8.
Results Reference
result
Learn more about this trial
Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic
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