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Clinical Trials/NCT04643964
NCT04643964CompletedNot Applicable

Building Mental Health Resilience in the COVID-19 Pandemic.

Ohio State University1 site in 1 country655 target enrollmentStarted: November 17, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
655
Locations
1
Primary Endpoint
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)

Study Overview

Brief Summary

In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. (3) A control condition involving no skills. Among those in the entrée condition, participants are further randomized to one of three CBT skills. We plan on two sets of primary comparisons. First, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. Second, we will compare the entrée and sampler conditions. We will recruit participants from Amazon's Mechanical Turk program (MTurk). In the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. They will also be asked to practice skills introduced in the videos in the week following the intervention. In the control condition, participants will not watch videos. One week after the intervention, all participants will respond to a follow-up assessment.

Detailed Description

Access to the study will be provided via the MTurk website. Study measures and interventions will be provided via Qualtrics. To determine eligibility, participants will be asked to fill out a pre-screening measure of depressive symptoms, the Personal Health Questionnaire-9 (PHQ-9). Those who score 10 or higher will be eligible. After consenting to participate, participants will fill out baseline measures, be randomly assigned to a condition, participate in any condition related procedures, and then respond to a follow-up assessment one week later.

Each brief intervention consists of watching a series of videos. After each video, participants in the intervention conditions will be prompted to answer a series of questions to practice the skills explained in the videos. For the entrée and sampler conditions, watching all videos and filling out any worksheets that are part of the initial intervention is expected to take approximately 30 minutes.

Participants in the entrée and sampler conditions will be asked to work on a coping skills worksheet over the next seven days (estimated to involve about 10 minutes of work). Participants will receive an email seven days after participating in the brief intervention, asking them to take part in the following portion of the study. Before beginning the follow-up activity, participants in the intervention conditions will be asked to upload the coping skills worksheet they worked on. All participants will be asked to respond to follow-up assessment measures at this point.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Participants are told they may or may not be asked to watch videos and fill out worksheets. More detailed descriptions of the interventions being tested are not provided.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Score above 10 on the Patient Health Questionnaire-9
  • •Are 18 years of age or older

Exclusion Criteria

  • Not provided

Arms & Interventions

Entrée: Interpersonal Skills

Experimental

Intervention: Entrée: Interpersonal skills (Behavioral)

Sampler Skills

Experimental

Intervention: Sampler skills (Behavioral)

Entrée: Cognitive Skills

Experimental

Intervention: Entrée: Cognitive skills (Behavioral)

Entrée: Behavioral Skills

Experimental

Intervention: Entrée: Behavioral skills (Behavioral)

Control

No Intervention

Participants are not given videos to watch until their involvement in the study ends.

Outcomes

Primary Outcomes

Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)

Time Frame: Baseline, 1-2 weeks after baseline

The Quick Inventory of Depressive Symptoms-Self Report is a 16-item self-report scale that measures depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.

Secondary Outcomes

  • Change in the Styles of Emotion Response Questionnaire (SERQ)(Baseline, 1-2 weeks after baseline)
  • Change in the Ways of Responding Questionnaire (WOR)(Baseline, 1-2 weeks after baseline)
  • Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3(Baseline, 1-2 weeks after baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel R. Strunk

Professor

Ohio State University

Study Sites (1)

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