Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic

Teachers College, Columbia University134 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Distress, Emotional Emotional Dysfunction Anxiety Depression

Interventions

Emotion Regulation Training via TelehealthBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Teachers College, Columbia University

New York, New York, United States

Outcomes

Primary Outcomes

Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)

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

Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)

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

Changes in Worry: Penn State Worry Questionnaire (PSWQ)

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

Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)

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

Changes in Functional Impairment: Sheehan Disability Scale (SDS)

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

Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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)