NCT04643964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

November 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 20, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

November 12, 2020

Results QC Date

September 8, 2022

Last Update Submit

May 17, 2024

Conditions

Keywords

DepressionVideo interventionCognitive behavioral skills

Outcome Measures

Primary Outcomes (1)

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

    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

Secondary Outcomes (3)

  • Change in the Ways of Responding Questionnaire (WOR)

    Baseline, 1-2 weeks after baseline

  • Change in the Styles of Emotion Response Questionnaire (SERQ)

    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

Study Arms (5)

Entrée: Cognitive Skills

EXPERIMENTAL
Behavioral: Entrée: Cognitive skills

Entrée: Behavioral Skills

EXPERIMENTAL
Behavioral: Entrée: Behavioral skills

Entrée: Interpersonal Skills

EXPERIMENTAL
Behavioral: Entrée: Interpersonal skills

Sampler Skills

EXPERIMENTAL
Behavioral: Sampler skills

Control

NO INTERVENTION

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

Interventions

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.

Entrée: Cognitive 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.

Entrée: Behavioral 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.

Entrée: Interpersonal Skills
Sampler skillsBEHAVIORAL

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.

Sampler Skills

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Daniel Strunk
Organization
The Ohio State University

Study Officials

  • Daniel R Strunk, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 25, 2020

Study Start

November 17, 2020

Primary Completion

June 5, 2021

Study Completion

June 5, 2021

Last Updated

May 20, 2024

Results First Posted

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Results will be posted to clinicaltrials.gov within one year after completion of the final participant's participation in the clinical trial. Following initial publication, deidentified individual participant data (IPD) that underlie results in the primary outcome data reported will be available on reasonable request for 5 years after study completion.

Time Frame
IPD will be available upon reasonable request within one year of primary outcome manuscript being published.
Access Criteria
Proposals should be directed to Daniel R. Strunk at strunk.20@osu.edu

Locations