- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04361045
StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students
Randomized Control Trial of Online Mental Health Promotion Program for University Students
This study was a randomized controlled trial of an original online mental health promotion program. This study aimed to: 1) establish program effectiveness by examining symptom change between conditions and 2) examine predictors of symptom change. The program was previously tested in open trial feasibility study by the same Principal Investigator and has since been rebuilt as informed by feasibility findings and participant qualitative feedback.
Participants were randomly assigned to either a waitlist condition or eight weeks of the intervention condition. Baseline, posttest, and follow-up electronic surveys collected self-reported symptoms of stress, anxiety, and depression. Motivational variables were also assessed at baseline and then tested as moderators of intervention effects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- enrolled as a student at UCLA (Fall 2017 - Winter 2018)
Exclusion Criteria:
- concurrent enrollment in a similar online anxiety and depression treatment study on campus
- invalid data reporting (e.g., straight-lined responses to surveys) -- post hoc exclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Condition
Participants in this condition were delivered 8 weeks of online intervention modules and then were invited to complete a posttest survey.
|
The intervention (app.striveweekly.com) delivered eight modules: introduction module, six skills modules, and wrap-up module. The two program "brand name" versions had identical content, but different aesthetic schemes. Modules were released week-by-week, and participants self-guided through content. To facilitate skills practice, every module was accompanied by: a weekly intro email and reminder emails; an "extras" section for tips/suggestions; and a weekly prize drawing. The "Dashboard" section of the intervention displayed user progress. The "Campus" section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity. Strategies/skills included: Psychoeducation; Self-monitoring; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Maintenance planning.
Other Names:
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No Intervention: Waitlist Condition
Participants in this condition received no intervention content nor communications for 8 weeks and then were invited to complete a posttest survey.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS-21)
Time Frame: [Time Frame: Baseline to Posttest (~8 weeks)]
|
This 21-item self-report measure assesses symptoms of depression, anxiety, and stress.
Individual items are rated 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time), with total scores ranging 0 - 63. Lower scores at posttest relative to baseline indicate improvement.
|
[Time Frame: Baseline to Posttest (~8 weeks)]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program Adherence
Time Frame: [Time Frame: Baseline to Posttest (~8 weeks)]
|
This outcome was assessed based on number of modules with 1+ skills practice log.
Skills practice logs were recorded as behavioral data, stored within the online platform's database of user account activity.
|
[Time Frame: Baseline to Posttest (~8 weeks)]
|
|
Program Satisfaction
Time Frame: Posttest (~8 weeks)
|
This 5-item measure was adapted from the Client Satisfaction Questionnaire.
Individual items are rated 1 (Poor) to 4 (Excellent), with total scores ranging 5 - 20.
Higher scores indicate more satisfaction.
|
Posttest (~8 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Happiness Scale
Time Frame: [Time Frame: Baseline to Posttest (~8 weeks)]
|
This 4-item self-report measure assesses subjective happiness.
Individual items are rated 1 to 7, with total scores ranging 4 - 28.
Higher scores at posttest relative to baseline indicate improvement.
|
[Time Frame: Baseline to Posttest (~8 weeks)]
|
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Patient Health Questionnaire-9
Time Frame: [Time Frame: Baseline to Posttest (~8 weeks)]
|
This 9-item self-report measure assesses symptoms of major depressive disorder.
Individual items are rated 0 (Not at all) to 3 (Nearly every day), with total scores ranging 0 - 27. Lower scores at posttest relative to baseline indicate improvement.
|
[Time Frame: Baseline to Posttest (~8 weeks)]
|
Collaborators and Investigators
Investigators
- Study Chair: Denise Chavira, PhD, University of California, Los Angeles
- Principal Investigator: Leslie Leslie, PhD, Harvard University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-000761
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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