Brief Video Interventions for Depression

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT04643964
Collaborator
(none)
531
1
5
6.6
80.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Entrée: Cognitive skills
  • Behavioral: Entrée: Behavioral skills
  • Behavioral: Entrée: Interpersonal skills
  • Behavioral: Sampler skills
N/A

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
Actual Enrollment :
531 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to one of three conditions: (1) a brief intervention focused on one domain of coping skills (the entrée condition), (2) a brief intervention focused on three domains of coping skills (the sampler condition), or (3) a no-intervention control condition. If participants are randomly assigned to the first condition, they will be further randomized into one of three brief interventions: (1) a focus on cognitive coping skills, (2) a focus on behavioral coping skills, or (3) a focus on interpersonal coping skills. The sampler condition will involve limited coverage of each of these same three types of skills. The target sample size was 501 participants. We enrolled 531 to account for 30 participants who failed at least one attention check. This resulted in a sample of 531 who were randomized and 501 who were both randomized and did not fail an attention check.Participants will be randomly assigned to one of three conditions: (1) a brief intervention focused on one domain of coping skills (the entrée condition), (2) a brief intervention focused on three domains of coping skills (the sampler condition), or (3) a no-intervention control condition. If participants are randomly assigned to the first condition, they will be further randomized into one of three brief interventions: (1) a focus on cognitive coping skills, (2) a focus on behavioral coping skills, or (3) a focus on interpersonal coping skills. The sampler condition will involve limited coverage of each of these same three types of skills. The target sample size was 501 participants. We enrolled 531 to account for 30 participants who failed at least one attention check. This resulted in a sample of 531 who were randomized and 501 who were both randomized and did not fail an attention check.
Masking:
None (Open Label)
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.
Primary Purpose:
Treatment
Official Title:
Building Mental Health Resilience in the COVID-19 Pandemic.
Actual Study Start Date :
Nov 17, 2020
Actual Primary Completion Date :
Jun 5, 2021
Actual Study Completion Date :
Jun 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Entrée: Cognitive Skills

Behavioral: Entrée: Cognitive skills
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.

Experimental: Entrée: Behavioral Skills

Behavioral: 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

Behavioral: 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.

Experimental: Sampler Skills

Behavioral: Sampler skills
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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) [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 Outcome Measures

  1. Change in the Ways of Responding Questionnaire (WOR) [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.

  2. Change in the Styles of Emotion Response Questionnaire (SERQ) [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 18-90 in each domain, with higher scores indicating greater coping skill use.

  3. Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Score above 10 on the Patient Health Questionnaire-9

  • Are 18 years of age or older

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychology Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University

Investigators

  • Principal Investigator: Daniel R Strunk, Ph.D., Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel R. Strunk, Professor, Ohio State University
ClinicalTrials.gov Identifier:
NCT04643964
Other Study ID Numbers:
  • 2020B0326
First Posted:
Nov 25, 2020
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel R. Strunk, Professor, Ohio State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2021