Clinical trial NCT04615416: Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic
Official title: Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress, Emotional
Emotional Dysfunction
Anxiety
Depression
Keywords: Emotion Regulation
Distress Disorders
Anxiety
Depression
COVID-19 Pandemic
Telehealth
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2020-11-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
measure: Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
measure: Changes in Worry: Penn State Worry Questionnaire (PSWQ)
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
measure: Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
measure: Changes in Functional Impairment: Sheehan Disability Scale (SDS)
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
measure: Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
measure: Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
timeFrame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Secondary outcomes:
measure: Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Depression Symptoms
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Distress
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)
timeFrame: Semi-weekly over the course of four weeks
measure: Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)
timeFrame: Semi-weekly over the course of four weeks
measure: Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-Treatment (4-5 weeks after starting treatment)
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College, Columbia University
name: Douglas S Mennin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.beth.2017.09.001. Epub 2017 Sep 8.