Trial Outcomes & Findings for Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety (NCT NCT04226742)
NCT ID: NCT04226742
Last Updated: 2023-06-29
Results Overview
The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression.
COMPLETED
NA
107 participants
Absolute scores at Week 16
2023-06-29
Participant Flow
Participants were recruited from the Mental Health America screening website between Feburary 2021 and September 2021. The first participant was enrolled on February 18, 2021 and the last participant was enrolled on September September 3, 2021.
Participant milestones
| Measure |
Treatment
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
51
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
Reasons for withdrawal
| Measure |
Treatment
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
13
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety
Baseline characteristics by cohort
| Measure |
Treatment
n=56 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=51 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.41 years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
34.57 years
STANDARD_DEVIATION 13.39 • n=7 Participants
|
33.92 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Depression Anxiety Stress Scale (DASS)
|
65.7 scores on a scale
STANDARD_DEVIATION 23.8 • n=5 Participants
|
63.2 scores on a scale
STANDARD_DEVIATION 24.3 • n=7 Participants
|
64.51 scores on a scale
STANDARD_DEVIATION 24.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: Absolute scores at Week 16Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression.
Outcome measures
| Measure |
Treatment
n=35 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=35 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Depression Scores at Week 16
|
15.7 score on a scale
Standard Deviation 12.9
|
15.7 score on a scale
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: Absolute scores at Week 16Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
The primary outcome of symptoms of anxiety will be measured with the self-report anxiety subscale of the Depression Anxiety Stress Scale (DASS). The subscale for anxiety ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of anxiety and higher values (highest value = 28) indicating higher levels of anxiety.
Outcome measures
| Measure |
Treatment
n=35 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=35 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Anxiety Scores at 16 Weeks
|
12.4 score on a scale
Standard Deviation 10.8
|
11.0 score on a scale
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: Absolute scores at Week 16Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
A secondary outcome is the Frequency of Actions and Thoughts (FATS), which assesses the use of cognitive and behavioral skills. Total scores indicate the average of each item rating and range from 0-4. Lower scores indicate less frequent use of cognitive and behavioral skills and higher scores indicate more frequent use of cognitive and behavioral skills.
Outcome measures
| Measure |
Treatment
n=35 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=35 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Cognitive and Behavioral Skills Scores at 16 Weeks
|
2.03 score on a scale
Standard Deviation 0.84
|
1.78 score on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Absolute scores at Week 16Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260 with lower scores representing lower coping self-efficacy and higher scores indicating higher coping self-efficacy.
Outcome measures
| Measure |
Treatment
n=56 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=51 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Self-efficacy Scores at 16 Weeks
|
134.0 score on a scale
Standard Deviation 58.6
|
124.0 score on a scale
Standard Deviation 57.8
|
SECONDARY outcome
Timeframe: Absolute scores at Week 16Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. Data reported are the SAQ total scores with lower levels indicating less supportive accountability and higher values indicating greater supportive accountability.
Outcome measures
| Measure |
Treatment
n=35 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=35 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Accountability Scores at 16 Weeks
|
75.1 score on a scale
Standard Deviation 23.3
|
74.7 score on a scale
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: Absolute scores at Week 16Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces T-scores that have a mean of 50 and a standard deviation of 10. Lower scores indicate lower participation in social roles and activities and higher scores indicate higher participation in social roles and activities.
Outcome measures
| Measure |
Treatment
n=35 Participants
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
|
Control
n=35 Participants
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
|
|---|---|---|
|
Social Functioning Scores at 16 Weeks
|
78.4 T-score
Standard Deviation 14.2
|
79.3 T-score
Standard Deviation 16.0
|
Adverse Events
Treatment
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