Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic

NCT04615416 | Completed DMC

• 1 other identifier: 20-269
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress, Emotional; Emotional Dysfunction; Anxiety; Depression

Keywords

Emotion Regulation; Distress Disorders; Anxiety; Depression; COVID-19 Pandemic; Telehealth

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety

  Semi-weekly over the course of four weeks

• Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression

  Semi-weekly over the course of four weeks

• Semi-Weekly Measures of Treatment Changes in Depression Symptoms

  Semi-weekly over the course of four weeks

• Semi-Weekly Measures of Treatment Changes in Distress

  Semi-weekly over the course of four weeks

• Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)

  Semi-weekly over the course of four weeks

Study Arms (1)

Emotion Regulation Training via Telehealth

EXPERIMENTAL

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

Interventions

Emotion Regulation Training via Telehealth BEHAVIORAL

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).

Also known as: Emotion Regulation Therapy (ERT)

Emotion Regulation Training via Telehealth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead
• University of Michigan: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (2)

• 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.

  PMID: 29504794 BACKGROUND

• 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.

  PMID: 29704969 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Emotional Regulation; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Douglas S Mennin, Ph.D.

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 4, 2020
• Study Start: May 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: August 6, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)