Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety
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|ClinicalTrials.gov Identifier: NCT04226742|
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression, Anxiety||Behavioral: ADAPT Platform (Treatment) Behavioral: ADAPT Comparison (Control)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned to receive either the treatment condition (ADAPT platform, iCBT platform comprised of didactic and interactive content), or a control condition (iCBT comparison platform comprised only of didactic content).|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants will be unaware of which condition they have been assigned.|
|Official Title:||Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
Behavioral: 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.
Active Comparator: Control
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
Behavioral: 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.
- Change in Depression at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]The primary outcome of symptoms of depression will be measured with the self-report Depression Anxiety Stress Scale (DASS) which produces a single score from 0-56 as well as subscores for depression that ranges from 0-56.
- Change in Anxiety at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]The primary outcome of symptoms of anxiety will be measured with the self-report DASS, which produces a single score from 0-56.
- Change in Diagnostic Status at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]A secondary outcome is diagnostic status as assessed using the Structured Clinical Interview for DSM-5 (SCID-5). Diagnostic status will also be used as a moderator of change in depressive and anxiety symptoms.
- Change in use of cognitive and behavioral skills at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]A secondary outcome is the Cognitive and Behavioral Response to Stress Scale (CB-RSS), which produces separate scores for frequency and usefulness of cognitive and behavioral skills. Scores for frequency and usefulness each range from 0-54.
- Change in Self-efficacy at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260.
- Change in Accountability at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. The SAQ also produces scores of subscales including bond, accountability, and legitimacy.
- Change in Social Functioning at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8 and Week 16 ]Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces raw scores from 8 to 40. These scores can be standardized to be reported as T-scores that have a mean of 50 and a standard deviation of 10.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226742
|Contact: Stephen M Schueller, PhDfirstname.lastname@example.org|
|Principal Investigator:||Stephen M Schueller, PhD||University of California, Irvine|