- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04643964
Brief Video Interventions for Depression
Building Mental Health Resilience in the COVID-19 Pandemic.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Department of Psychology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Score above 10 on the Patient Health Questionnaire-9
- Are 18 years of age or older
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Entrée: Cognitive Skills
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In this condition, participants view a video-based intervention covering cognitive emotion regulation skills.
This intervention asks participants to respond to questions and practice identifying and evaluating their own thoughts using an intervention worksheet.
One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
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|
Experimental: Entrée: Behavioral Skills
|
In this condition, participants view a video-based intervention covering behavioral emotion regulation skills.
This intervention asks participants to respond to questions and practice scheduling activities that might give them a sense of pleasure or accomplishment using an intervention worksheet.
One week after the intervention, participants are asked to upload a worksheet showing their efforts to schedule and engage in behaviors in line with the intervention skills.
|
|
Experimental: Entrée: Interpersonal Skills
|
In this condition, participants view a video-based intervention covering interpersonal emotion regulation skills.
This intervention asks participants to respond to questions and practice communicating effectively using an intervention worksheet.
One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
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|
Experimental: Sampler Skills
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In this condition, participants view a video-based intervention covering three emotion regulation skills: cognitive, behavioral, and interpersonal skills.
This intervention asks participants to respond to questions and practice using skills using intervention worksheets.
One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
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No Intervention: Control
Participants are not given videos to watch until their involvement in the study ends.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
Time Frame: Baseline, 1-2 weeks after baseline
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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.
|
Baseline, 1-2 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Ways of Responding Questionnaire (WOR)
Time Frame: Baseline, 1-2 weeks after baseline
|
The Ways of Responding Questionnaire is a measure of compensatory skills taught in CBT for depression.
Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given.
Quality scores range from 0 to 6, with higher scores indicating greater CBT skills.
|
Baseline, 1-2 weeks after baseline
|
|
Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3
Time Frame: Baseline, 1-2 weeks after baseline
|
The University of California, Los Angeles (UCLA) Loneliness Scale, Version 3 is a 20-item self-report scale that measures subjective feelings of loneliness and isolation.
Scores range from 20-80, with higher scores indicating greater subjective experience of loneliness.
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Baseline, 1-2 weeks after baseline
|
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Change in the Styles of Emotion Response Questionnaire (SERQ)
Time Frame: Baseline, 1-2 weeks after baseline
|
The Styles of Emotion Response Questionnaire is a 36-item self-report scale that measures the extent to which respondents endorse four different domains of coping skills: cognitive, behavioral, interpersonal, and mindfulness. For each item, participants are asked how often they use the strategy and how much feeling upset negatively impacts the use of this strategy. Scores from the first three skills are secondary outcomes. Scores range from 72-360, with higher scores indicating greater coping skill use. For the purpose of this study, we used the Cognitive, Behavioral, and Interpersonal scales. Scores in each subscale range from 18-90, with higher scores indicating greater coping skill use in that domain. |
Baseline, 1-2 weeks after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel R Strunk, Ph.D., Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020B0326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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