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.
COMPLETED
NA
655 participants
Baseline, 1-2 weeks after baseline
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
| 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
| 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
| 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 baselinePopulation: 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
| 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 baselinePopulation: 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
| 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 baselinePopulation: 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
| 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 baselinePopulation: 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
| 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
Entrée: Behavioral Skills
Entrée: Interpersonal Skills
Sampler Skills
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place