Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic (ERT-P)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Distress, Emotional; Emotional Dysfunction
• Intervention / Treatment: Behavioral: Emotion Regulation Training via Telehealth

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Teachers College, Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Emotion Regulation Training via Telehealth; 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).; Other Names: Emotion Regulation Therapy (ERT)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Teachers College, Columbia University
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Douglas S Mennin, Ph.D., Teachers College, Columbia University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Telehealth; Emotion Regulation; COVID-19 Pandemic; Distress Disorders
• Additional Relevant MeSH Terms: Behavioral Symptoms; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Depression
• Other Study ID Numbers: 20-269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No