StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students
Primary Purpose
Anxiety, Depressive Symptoms, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
StriveWeekly
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Condition
Waitlist Condition
Arm Description
Participants in this condition were delivered 8 weeks of online intervention modules and then were invited to complete a posttest survey.
Participants in this condition received no intervention content nor communications for 8 weeks and then were invited to complete a posttest survey.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04361045
First Posted
April 21, 2020
Last Updated
May 15, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04361045
Brief Title
StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students
Official Title
Randomized Control Trial of Online Mental Health Promotion Program for University Students
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
March 18, 2018 (Actual)
Study Completion Date
March 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depressive Symptoms, Stress, Psychological
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1631 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
Participants in this condition were delivered 8 weeks of online intervention modules and then were invited to complete a posttest survey.
Arm Title
Waitlist Condition
Arm Type
No Intervention
Arm Description
Participants in this condition received no intervention content nor communications for 8 weeks and then were invited to complete a posttest survey.
Intervention Type
Behavioral
Intervention Name(s)
StriveWeekly
Other Intervention Name(s)
The Happiness Challenge, ReBoot Camp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression Anxiety and Stress Scale (DASS-21)
Description
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
[Time Frame: Baseline to Posttest (~8 weeks)]
Secondary Outcome Measure Information:
Title
Program Adherence
Description
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
[Time Frame: Baseline to Posttest (~8 weeks)]
Title
Program Satisfaction
Description
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.
Time Frame
Posttest (~8 weeks)
Other Pre-specified Outcome Measures:
Title
Subjective Happiness Scale
Description
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
[Time Frame: Baseline to Posttest (~8 weeks)]
Title
Patient Health Questionnaire-9
Description
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
[Time Frame: Baseline to Posttest (~8 weeks)]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Chavira, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leslie Leslie, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35343901
Citation
Hanano M, Rith-Najarian L, Boyd M, Chavira D. Measuring Adherence Within a Self-Guided Online Intervention for Depression and Anxiety: Secondary Analyses of a Randomized Controlled Trial. JMIR Ment Health. 2022 Mar 28;9(3):e30754. doi: 10.2196/30754.
Results Reference
derived
Learn more about this trial
StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students
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