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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04361045
Other study ID # 17-000761
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2017
Est. completion date March 18, 2018

Study information

Verified date May 2023
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1631
Est. completion date March 18, 2018
Est. primary completion date March 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
StriveWeekly
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.

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Subjective Happiness Scale 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)]
Other Patient Health Questionnaire-9 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)]
Primary Depression Anxiety and Stress Scale (DASS-21) 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 Program Adherence 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)]
Secondary Program Satisfaction 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)
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