Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic

Conditions
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Distress, Emotional, Emotional Dysfunction, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Emotion Regulation Training via Telehealth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion Regulation Training via Telehealth<br>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. | Behavioral: Emotion Regulation Training via Telehealth<br>* 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).<br>* Other names: Emotion Regulation Therapy (ERT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ) | Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 
| Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS) | Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 
| Changes in Worry: Penn State Worry Questionnaire (PSWQ) | Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 
| Changes in Rumination: Rumination-Reflection Questionnaire (RRQ) | Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 
| Changes in Functional Impairment: Sheehan Disability Scale (SDS) | Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 
| Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) | Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 
| 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) | Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 over the course of four weeks | 
| 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 over the course of four weeks | 
| Semi-Weekly Measures of Treatment Changes in Depression Symptoms | Quick Inventory of Depressive Symptoms(QUIDS) | Semi-weekly over the course of four weeks | 
| Semi-Weekly Measures of Treatment Changes in Distress | Distress Thermometer (DT) | Semi-weekly over the course of four weeks | 
| 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 over the course of four weeks | 
| 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 over the course of four weeks | 
| 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 over the course of four weeks | 
| 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 over the course of four weeks | 
| 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) | Semi-weekly over the course of four weeks | 
| Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ) | Scale = 1-4 (minimum = 4; maximum = 16; higher scores indicate better outcomes) | Post-Treatment (4-5 weeks after starting treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Emotion Regulation, Distress Disorders, Depression, COVID-19 Pandemic, Telehealth