Trial Outcomes & Findings for Brief Video Interventions for Depression (NCT NCT04643964)

NCT ID: NCT04643964

Last Updated: 2024-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

655 participants

Primary outcome timeframe

Baseline, 1-2 weeks after baseline

Results posted on

2024-05-20

Participant Flow

951 participants were eligible. 272 participants discontinued before randomization, 6 participants did not provide sufficient identification to invite them to Time 2 of the study, and 18 participants attempted to complete Time 1 multiple times.

Participant milestones

Participant milestones
Measure
Entrée: Cognitive Skills
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.
Entrée: Behavioral Skills
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.
Entrée: Interpersonal Skills
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.
Sampler Skills
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.
Control
Participants are not given videos to watch until their involvement in the study ends.
Overall Study
STARTED
86
90
89
258
132
Overall Study
COMPLETED
30
23
33
115
73
Overall Study
NOT COMPLETED
56
67
56
143
59

Reasons for withdrawal

Reasons for withdrawal
Measure
Entrée: Cognitive Skills
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.
Entrée: Behavioral Skills
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.
Entrée: Interpersonal Skills
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.
Sampler Skills
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.
Control
Participants are not given videos to watch until their involvement in the study ends.
Overall Study
Lost to Follow-up
55
59
54
129
48
Overall Study
Failed attention check
1
8
2
14
11

Baseline Characteristics

Number differs because some participants did not enter their age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entrée: Cognitive Skills
n=86 Participants
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.
Entrée: Behavioral Skills
n=90 Participants
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.
Entrée: Interpersonal Skills
n=89 Participants
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.
Sampler Skills
n=258 Participants
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.
Control
n=132 Participants
Participants are not given videos to watch until their involvement in the study ends.
Total
n=655 Participants
Total of all reporting groups
Age, Continuous
36.15 years
STANDARD_DEVIATION 10.29 • n=86 Participants • Number differs because some participants did not enter their age.
34.95 years
STANDARD_DEVIATION 9.67 • n=88 Participants • Number differs because some participants did not enter their age.
37.07 years
STANDARD_DEVIATION 11.40 • n=89 Participants • Number differs because some participants did not enter their age.
35.50 years
STANDARD_DEVIATION 10.63 • n=257 Participants • Number differs because some participants did not enter their age.
36.48 years
STANDARD_DEVIATION 11.63 • n=132 Participants • Number differs because some participants did not enter their age.
35.93 years
STANDARD_DEVIATION 10.77 • n=652 Participants • Number differs because some participants did not enter their age.
Sex/Gender, Customized
Female
49 Participants
n=86 Participants
49 Participants
n=90 Participants
50 Participants
n=89 Participants
140 Participants
n=258 Participants
75 Participants
n=132 Participants
363 Participants
n=655 Participants
Sex/Gender, Customized
Male
35 Participants
n=86 Participants
37 Participants
n=90 Participants
36 Participants
n=89 Participants
110 Participants
n=258 Participants
49 Participants
n=132 Participants
267 Participants
n=655 Participants
Sex/Gender, Customized
Another gender
2 Participants
n=86 Participants
4 Participants
n=90 Participants
3 Participants
n=89 Participants
8 Participants
n=258 Participants
7 Participants
n=132 Participants
24 Participants
n=655 Participants
Sex/Gender, Customized
Did not give
0 Participants
n=86 Participants
0 Participants
n=90 Participants
0 Participants
n=89 Participants
0 Participants
n=258 Participants
1 Participants
n=132 Participants
1 Participants
n=655 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
0 Participants
n=86 Participants
1 Participants
n=90 Participants
1 Participants
n=89 Participants
2 Participants
n=258 Participants
0 Participants
n=132 Participants
4 Participants
n=655 Participants
Race/Ethnicity, Customized
Asian
6 Participants
n=86 Participants
7 Participants
n=90 Participants
4 Participants
n=89 Participants
21 Participants
n=258 Participants
6 Participants
n=132 Participants
44 Participants
n=655 Participants
Race/Ethnicity, Customized
Black
13 Participants
n=86 Participants
19 Participants
n=90 Participants
16 Participants
n=89 Participants
30 Participants
n=258 Participants
17 Participants
n=132 Participants
95 Participants
n=655 Participants
Race/Ethnicity, Customized
Hispanic/Latino
5 Participants
n=86 Participants
8 Participants
n=90 Participants
7 Participants
n=89 Participants
15 Participants
n=258 Participants
6 Participants
n=132 Participants
41 Participants
n=655 Participants
Race/Ethnicity, Customized
Middle Eastern/North African
1 Participants
n=86 Participants
0 Participants
n=90 Participants
0 Participants
n=89 Participants
1 Participants
n=258 Participants
0 Participants
n=132 Participants
2 Participants
n=655 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
1 Participants
n=86 Participants
0 Participants
n=90 Participants
0 Participants
n=89 Participants
1 Participants
n=258 Participants
1 Participants
n=132 Participants
3 Participants
n=655 Participants
Race/Ethnicity, Customized
White
50 Participants
n=86 Participants
48 Participants
n=90 Participants
56 Participants
n=89 Participants
172 Participants
n=258 Participants
100 Participants
n=132 Participants
426 Participants
n=655 Participants
Race/Ethnicity, Customized
Other/multi-racial
10 Participants
n=86 Participants
7 Participants
n=90 Participants
5 Participants
n=89 Participants
16 Participants
n=258 Participants
2 Participants
n=132 Participants
40 Participants
n=655 Participants

PRIMARY outcome

Timeframe: Baseline, 1-2 weeks after baseline

Population: Number differs because: (1) some participants did not enter information in to complete the measure, and (2) some participants did not move on to Time 2.

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.

Outcome measures

Outcome measures
Measure
Entrée: Cognitive Skills
n=86 Participants
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.
Entrée: Behavioral Skills
n=90 Participants
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.
Entrée: Interpersonal Skills
n=89 Participants
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.
Sampler Skills
n=258 Participants
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.
Control
n=132 Participants
Participants are not given videos to watch until their involvement in the study ends.
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
Time 1, Baseline
13.67 units on a scale
Standard Deviation 3.90
14.09 units on a scale
Standard Deviation 4.67
14.29 units on a scale
Standard Deviation 4.15
13.79 units on a scale
Standard Deviation 4.38
14.03 units on a scale
Standard Deviation 4.38
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
Time 2, 1-2 weeks after baseline
13.00 units on a scale
Standard Deviation 4.32
11.91 units on a scale
Standard Deviation 5.61
12.94 units on a scale
Standard Deviation 4.44
11.47 units on a scale
Standard Deviation 4.72
12.60 units on a scale
Standard Deviation 5.36

SECONDARY outcome

Timeframe: Baseline, 1-2 weeks after baseline

Population: Number differs because: (1) some participants did not enter information in to complete the measure, (2) some participants did not move on to Time 2, and (3) some participants entered in data that was not possible to code (e.g., "N/A").

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.

Outcome measures

Outcome measures
Measure
Entrée: Cognitive Skills
n=86 Participants
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.
Entrée: Behavioral Skills
n=90 Participants
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.
Entrée: Interpersonal Skills
n=89 Participants
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.
Sampler Skills
n=258 Participants
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.
Control
n=132 Participants
Participants are not given videos to watch until their involvement in the study ends.
Change in the Ways of Responding Questionnaire (WOR)
Time 1, Baseline
3.58 units on a scale
Standard Deviation .92
3.70 units on a scale
Standard Deviation .95
3.71 units on a scale
Standard Deviation .75
3.70 units on a scale
Standard Deviation .87
3.7 units on a scale
Standard Deviation .88
Change in the Ways of Responding Questionnaire (WOR)
Time 2, 1-2 weeks after baseline
3.88 units on a scale
Standard Deviation .97
4.08 units on a scale
Standard Deviation .94
3.87 units on a scale
Standard Deviation .75
4.02 units on a scale
Standard Deviation 1.01
3.96 units on a scale
Standard Deviation 1.02

SECONDARY outcome

Timeframe: Baseline, 1-2 weeks after baseline

Population: Number differs because: (1) some participants did not enter information in to complete the measure, (2) some participants did not move on to Time 2, and (3) some participants entered in data that was not possible to code (e.g., "N/A").

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.

Outcome measures

Outcome measures
Measure
Entrée: Cognitive Skills
n=86 Participants
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.
Entrée: Behavioral Skills
n=90 Participants
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.
Entrée: Interpersonal Skills
n=89 Participants
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.
Sampler Skills
n=258 Participants
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.
Control
n=132 Participants
Participants are not given videos to watch until their involvement in the study ends.
Change in the Styles of Emotion Response Questionnaire (SERQ)
Cognitive Subscale: Time 1, Baseline
33.45 units on a scale
Standard Deviation 6.80
32.85 units on a scale
Standard Deviation 6.50
33.31 units on a scale
Standard Deviation 5.31
32.69 units on a scale
Standard Deviation 7.56
32.57 units on a scale
Standard Deviation 7.43
Change in the Styles of Emotion Response Questionnaire (SERQ)
Cognitive Subscale: Time 2, 1-2 weeks after baseline
33.41 units on a scale
Standard Deviation 6.96
32.61 units on a scale
Standard Deviation 6.62
34.12 units on a scale
Standard Deviation 5.99
34.04 units on a scale
Standard Deviation 7.56
33.31 units on a scale
Standard Deviation 7.53
Change in the Styles of Emotion Response Questionnaire (SERQ)
Behavioral Subscale: Time 1, Baseline
33.31 units on a scale
Standard Deviation 8.09
31.36 units on a scale
Standard Deviation 7.86
32.44 units on a scale
Standard Deviation 6.02
31.84 units on a scale
Standard Deviation 8.35
31.32 units on a scale
Standard Deviation 8.06
Change in the Styles of Emotion Response Questionnaire (SERQ)
Behavioral Subscale: Time 2, 1-2 weeks after baseline
35.17 units on a scale
Standard Deviation 6.85
34.13 units on a scale
Standard Deviation 6.88
32.88 units on a scale
Standard Deviation 6.91
33.22 units on a scale
Standard Deviation 8.18
32.73 units on a scale
Standard Deviation 8.14
Change in the Styles of Emotion Response Questionnaire (SERQ)
Interpersonal Subscale: Time 1, Baseline
32.11 units on a scale
Standard Deviation 7.50
30.38 units on a scale
Standard Deviation 8.31
30.75 units on a scale
Standard Deviation 6.73
30.53 units on a scale
Standard Deviation 8.37
30.88 units on a scale
Standard Deviation 8.43
Change in the Styles of Emotion Response Questionnaire (SERQ)
Interpersonal Subscale: Time 2, 1-2 weeks after baseline
33.38 units on a scale
Standard Deviation 6.75
31.43 units on a scale
Standard Deviation 7.44
31.15 units on a scale
Standard Deviation 6.49
31.16 units on a scale
Standard Deviation 8.44
31.16 units on a scale
Standard Deviation 8.34

SECONDARY outcome

Timeframe: Baseline, 1-2 weeks after baseline

Population: Number differs because: (1) some participants did not enter information in to complete the measure, (2) some participants did not move on to Time 2, and (3) some participants entered in data that was not possible to code (e.g., "N/A").

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.

Outcome measures

Outcome measures
Measure
Entrée: Cognitive Skills
n=86 Participants
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.
Entrée: Behavioral Skills
n=90 Participants
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.
Entrée: Interpersonal Skills
n=89 Participants
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.
Sampler Skills
n=258 Participants
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.
Control
n=132 Participants
Participants are not given videos to watch until their involvement in the study ends.
Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3
Time 1, Baseline
53.87 units on a scale
Standard Deviation 9.16
55.80 units on a scale
Standard Deviation 9.25
54.70 units on a scale
Standard Deviation 9.22
53.97 units on a scale
Standard Deviation 9.53
54.66 units on a scale
Standard Deviation 10.10
Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3
Time 2, 1-2 weeks after baseline
52.59 units on a scale
Standard Deviation 10.54
54.57 units on a scale
Standard Deviation 10.76
56.83 units on a scale
Standard Deviation 8.16
53.20 units on a scale
Standard Deviation 10.40
54.20 units on a scale
Standard Deviation 10.80

Adverse Events

Entrée: Cognitive Skills

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Entrée: Behavioral Skills

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Entrée: Interpersonal Skills

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sampler Skills

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Strunk

The Ohio State University

Phone: 6146884891

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place