Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic
- Conditions
- AnxietyDepressionDistress, EmotionalEmotional Dysfunction
- Interventions
- Behavioral: Emotion Regulation Training via Telehealth
- Registration Number
- NCT04615416
- Lead Sponsor
- Teachers College, Columbia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Emotion Regulation Training via Telehealth Emotion Regulation Training via Telehealth 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.
- Primary Outcome Measures
Name Time Method Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate better outcomes)
Changes in Worry: Penn State Worry Questionnaire (PSWQ) Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ) Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Functional Impairment: Sheehan Disability Scale (SDS) Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes)
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes)
Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ) Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes)
Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS) Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes)
- Secondary Outcome Measures
Name Time Method Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ) Post-Treatment (4-5 weeks after starting treatment) Scale = 1-4 (minimum = 4; maximum = 16; higher scores indicate better outcomes)
Semi-Weekly Measures of Treatment Changes in Distress Semi-weekly over the course of four weeks Distress Thermometer (DT)
Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ) Semi-weekly over the course of four weeks 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) Semi-weekly over the course of four weeks Scale = 1-5 (minimum = 6; maximum = 30; higher scores indicate better outcomes)
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ) Semi-weekly over the course of four weeks 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) Semi-weekly over the course of four weeks Scale = 1-4 (minimum = 6; maximum = 24; higher scores indicate better outcomes)
Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression Semi-weekly over the course of four weeks Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Semi-Weekly Measures of Treatment Changes in Depression Symptoms Semi-weekly over the course of four weeks Quick Inventory of Depressive Symptoms(QUIDS)
Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ) Semi-weekly over the course of four weeks Scale: 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety Semi-weekly over the course of four weeks Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Trial Locations
- Locations (1)
Teachers College, Columbia University
🇺🇸New York, New York, United States