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OpenTrials
Completed

NCT Number: NCT04615416

Emotion Regulation Training Via Telehealth 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.

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Key information

Conditions

Distress, Emotional Anxiety Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Emotional Dysfunction Emotional Regulation Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Self-Control Social Behavior Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teachers College, Columbia University

New York, 10027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Emotion Regulation Therapy (ERT)

Primary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

  3. Changes in Worry: Penn State Worry Questionnaire (PSWQ)

    Time frame: 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)

  4. Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)

    Time frame: 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)

  5. Changes in Functional Impairment: Sheehan Disability Scale (SDS)

    Time frame: 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)

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

    Time frame: 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)

  7. Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose

    Time frame: 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)

Secondary outcomes

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

    Time frame: Semi-weekly over the course of four weeks

    Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)

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

    Time frame: Semi-weekly over the course of four weeks

    Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)

  3. Semi-Weekly Measures of Treatment Changes in Depression Symptoms

    Time frame: Semi-weekly over the course of four weeks

    Quick Inventory of Depressive Symptoms(QUIDS)

  4. Semi-Weekly Measures of Treatment Changes in Distress

    Time frame: Semi-weekly over the course of four weeks

    Distress Thermometer (DT)

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

    Time frame: Semi-weekly over the course of four weeks

    Scale: 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)

  6. Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)

    Time frame: Semi-weekly over the course of four weeks

    Scale = 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)

  7. Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)

    Time frame: Semi-weekly over the course of four weeks

    Scale = 1-5 (minimum = 6; maximum = 30; higher scores indicate better outcomes)

  8. Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)

    Time frame: Semi-weekly over the course of four weeks

    Scale = 1-5 (minimum = 5; maximum = 25; higher scores indicate better outcomes)

  9. Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)

    Time frame: Semi-weekly over the course of four weeks

    Scale = 1-4 (minimum = 6; maximum = 24; higher scores indicate better outcomes)

  10. Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)

    Time frame: Post-Treatment (4-5 weeks after starting treatment)

    Scale = 1-4 (minimum = 4; maximum = 16; higher scores indicate better outcomes)

Sponsors and collaborators

Lead sponsor

Teachers College, Columbia University

Other

Collaborators

  • University of Michigan

Registry information

Official study title

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

Acronym: ERT-P

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Nov 4, 2020
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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