N/A
N=538
StriveWeekly Online Mental Health Trial Post-pandemic
Anxiety · Depressive Symptoms · Stress, Emotional
Bottom Line
View on ClinicalTrials.gov: NCT04927845 ↗Enrolled (actual)
538
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Depression Anxiety and Stress Scale (DASS-21) — 16.9; 16.3; 16.5; 18.3 score on a scale — p=.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- StriveWeekly (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Harvard University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Anxiety and Stress Scale (DASS-21) |
16.9; 16.3; 16.5; 18.3 | .008 sig |
| SECONDARY Perceived Stress Scale |
19.1; 18.5; 18.7; 18.8 | .21 |
| SECONDARY The Warwick-Edinburgh Mental Wellbeing Scales |
23.1; 23.3; 22.8; 22.1 | .046 sig |
Summary
With the COVID-19 pandemic completely altering the landscape of higher education, students have been experiencing more stress than ever. With Harvard University's plan for students to return to campus for the 2021-2022 academic year, offering an online mental health program such as StriveWeekly could provide students with stress management support as they transition back after 1.5 years of remote learning. This study will use a randomized controlled trial design to test the effectiveness of a waitlist versus StriveWeekly. This study will allow us to test if a program that has previously demonstrated effectiveness with university students in reducing anxiety and depression symptoms will still be effective after the unprecedented amount of stressors during a global pandemic.
Primary aim: We aim to evaluate the effectiveness of StriveWeekly in preventing or reducing symptoms of anxiety and depression. The use of a waitlist condition will allow us to experimentally assess if the online intervention is responsible for decreasing / preventing worsened anxiety, depression, and stress symptoms over time. Given the previously established effectiveness of StriveWeekly as an indicated prevention program, we expect students in the intervention condition to experience significantly better symptoms compared to the waitlist from baseline to posttest. Alternatively, if the transition back from remote learning and/or the broad pandemic context interferes with the acceptability or effectiveness of StriveWeekly, then we might expect to see little to no significant differences between the online intervention condition and waitlist condition from baseline to posttest.
Secondary aims include: (a) testing moderators of intervention effectiveness and (b) evaluating the intervention in terms of acceptability (e.g., feedback on program name; demographically representativeness of student user sample; satisfactory adherence and satisfaction rates). Exploratory moderation analyses across groups will help determine whether or not the intervention condition produces unique or additive effects for students with certain characteristics over and above changes demonstrated by similar students in the waitlist condition. Acceptability analyses will allow for more nuanced evaluation of StriveWeekly's effectiveness as a program, beyond its ability to facilitate symptom reduction.
Eligibility Criteria
Inclusion Criteria
- enrolled as a student at Harvard College (academic year 2021-2022)
Exclusion Criteria
- invalid data reporting (e.g., straight-lined responses to surveys)
Data sourced from ClinicalTrials.gov (NCT04927845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.