NCT04643964

Brief Video Interventions for Depression

Completed NA Results posted Last updated 20 May 2024

What this trial tests

NA trial testing Entrée: Cognitive skills in Depressive Symptoms in 655 participants. Completed in 5 June 2021.

Timeline

17 November 2020

Primary endpoint
5 June 2021

5 June 2021

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	655
Start date	17 November 2020
Primary completion	5 June 2021
Estimated completion	5 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Entrée: Cognitive skills
• Entrée: Behavioral skills
• Entrée: Interpersonal skills
• Sampler skills

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →

Sponsor

Ohio State University

Who can join

18 and older, any sex, with Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Time 1, Baseline

Group	Value	95% CI
Entrée: Cognitive Skills	13.67	± 3.90
Entrée: Behavioral Skills	14.09	± 4.67
Entrée: Interpersonal Skills	14.29	± 4.15
Sampler Skills	13.79	± 4.38
Control	14.03	± 4.38

Time 2, 1-2 weeks after baseline

Group	Value	95% CI
Entrée: Cognitive Skills	13.00	± 4.32
Entrée: Behavioral Skills	11.91	± 5.61
Entrée: Interpersonal Skills	12.94	± 4.44
Sampler Skills	11.47	± 4.72
Control	12.60	± 5.36

Change in the Ways of Responding Questionnaire (WOR) Secondary · 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.

Time 1, Baseline

Group	Value	95% CI
Entrée: Cognitive Skills	3.58	± .92
Entrée: Behavioral Skills	3.70	± .95
Entrée: Interpersonal Skills	3.71	± .75
Sampler Skills	3.70	± .87
Control	3.7	± .88

Time 2, 1-2 weeks after baseline

Group	Value	95% CI
Entrée: Cognitive Skills	3.88	± .97
Entrée: Behavioral Skills	4.08	± .94
Entrée: Interpersonal Skills	3.87	± .75
Sampler Skills	4.02	± 1.01
Control	3.96	± 1.02

Change in the Styles of Emotion Response Questionnaire (SERQ) Secondary · 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

Cognitive Subscale: Time 1, Baseline

Group	Value	95% CI
Entrée: Cognitive Skills	33.45	± 6.80
Entrée: Behavioral Skills	32.85	± 6.50
Entrée: Interpersonal Skills	33.31	± 5.31
Sampler Skills	32.69	± 7.56
Control	32.57	± 7.43

Cognitive Subscale: Time 2, 1-2 weeks after baseline

Group	Value	95% CI
Entrée: Cognitive Skills	33.41	± 6.96
Entrée: Behavioral Skills	32.61	± 6.62
Entrée: Interpersonal Skills	34.12	± 5.99
Sampler Skills	34.04	± 7.56
Control	33.31	± 7.53

Behavioral Subscale: Time 1, Baseline

Group	Value	95% CI
Entrée: Cognitive Skills	33.31	± 8.09
Entrée: Behavioral Skills	31.36	± 7.86
Entrée: Interpersonal Skills	32.44	± 6.02
Sampler Skills	31.84	± 8.35
Control	31.32	± 8.06

Behavioral Subscale: Time 2, 1-2 weeks after baseline

Group	Value	95% CI
Entrée: Cognitive Skills	35.17	± 6.85
Entrée: Behavioral Skills	34.13	± 6.88
Entrée: Interpersonal Skills	32.88	± 6.91
Sampler Skills	33.22	± 8.18
Control	32.73	± 8.14

Interpersonal Subscale: Time 1, Baseline

Group	Value	95% CI
Entrée: Cognitive Skills	32.11	± 7.50
Entrée: Behavioral Skills	30.38	± 8.31
Entrée: Interpersonal Skills	30.75	± 6.73
Sampler Skills	30.53	± 8.37
Control	30.88	± 8.43

Interpersonal Subscale: Time 2, 1-2 weeks after baseline

Group	Value	95% CI
Entrée: Cognitive Skills	33.38	± 6.75
Entrée: Behavioral Skills	31.43	± 7.44
Entrée: Interpersonal Skills	31.15	± 6.49
Sampler Skills	31.16	± 8.44
Control	31.16	± 8.34

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

Time 1, Baseline

Group	Value	95% CI
Entrée: Cognitive Skills	53.87	± 9.16
Entrée: Behavioral Skills	55.80	± 9.25
Entrée: Interpersonal Skills	54.70	± 9.22
Sampler Skills	53.97	± 9.53
Control	54.66	± 10.10

Time 2, 1-2 weeks after baseline

Group	Value	95% CI
Entrée: Cognitive Skills	52.59	± 10.54
Entrée: Behavioral Skills	54.57	± 10.76
Entrée: Interpersonal Skills	56.83	± 8.16
Sampler Skills	53.20	± 10.40
Control	54.20	± 10.80

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.