StriveWeekly Online Mental Health Trial Post-pandemic

NCT04927845 | Completed Results

• 1 other identifier: IRB20-1337
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Depressive Symptoms; Stress, Emotional

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety and Stress Scale (DASS-21)

  Change in self-reported symptoms of depression, anxiety, and stress (completed via online surveys). Items are rated on a scale of 0-3, with higher scores indicating worse symptoms. Subscale total scores range from 0-21, and DASS-21 total scores range from 0-63.

  Baseline to Posttest (~8 weeks)

Secondary Outcomes (2)

• Perceived Stress Scale

  Baseline to Posttest (~8 weeks)

• The Warwick-Edinburgh Mental Wellbeing Scales

  Baseline to Posttest (~8 weeks)

Study Arms (2)

Immediate Intervention Condition

EXPERIMENTAL

Participants in this condition will receive 7-8 weeks of online intervention modules. Specific modules will be selected based on a campus-wide needs assessment conducted in May 2021.

Behavioral: StriveWeekly

Waitlist Condition

NO INTERVENTION

Participants in this condition will wait to receive StriveWeekly until after the Immediate Intervention condition is complete and participants from both conditions have completed the posttest survey.

Interventions

StriveWeekly BEHAVIORAL

The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is 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 displays user progress, including self-rating graphs and a history log of skills practice. 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.

Immediate Intervention Condition

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled as a student at Harvard College (academic year 2021-2022)

You may not qualify if:

• invalid data reporting (e.g., straight-lined responses to surveys)

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Leslie Rith-Najarian, Principal Investigator
• Organization: Strive Weekly Inc

leslie@striveweekly.com

3108002143

Study Officials

• Katie McLaughlin, PhD

  Harvard University

  STUDY CHAIR

• Leslie Rith-Najarian, PhD

  Strive Weekly Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: May 19, 2021
• Primary Completion: April 18, 2022
• Study Completion: June 10, 2022
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Locations

US (1)