Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic

Depression Clinical Trial

— ERT-P  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04615416
• Other study ID #: 20-269
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Depression
• Distress, Emotional
• Emotional Dysfunction

Intervention

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).

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Teachers College, Columbia University	University of Michigan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Semi-Weekly Measures of Treatment Changes in Depression Symptoms	Quick Inventory of Depressive Symptoms(QUIDS)	Semi-weekly over the course of four weeks
Secondary	Semi-Weekly Measures of Treatment Changes in Distress	Distress Thermometer (DT)	Semi-weekly over the course of four weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)