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AnxietyNCT04927845

StriveWeekly Online Mental Health Trial Post-pandemic

A study testing StriveWeekly in people with Anxiety and Depressive Symptoms, run by Harvard University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Depressive Symptoms, Stress, Emotional
What is being tested?
StriveWeekly
Could I receive a placebo?
No, everyone receives an active treatment
How many people
538 participants
Where
1 siteUnited States
Study dates
19 May 2021to 10 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harvard University

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: Randomized Controlled Trial (RCT) of StriveWeekly for Anxiety and Depression Prevention for College Students During COVID-19 (Coronavirus Disease 2019)

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.

Read the detailed description

Recruitment. Recruitment materials will be distributed via a mass email to all enrolled students, announcements over house emails lists (e.g., academic departments), and social media announcements.

Pre-trial needs assessment and pilot. Prior to the full RCT, we will conduct a campus-wide needs assessment survey to gather information about student needs and preferences related to mental health programming. Student responses will inform the specifics of StriveWeekly implementation during the academic year (e.g., preferred timing of programming, appropriateness of content across a diverse student population). After the needs assessment, we will invite a small group of students to participate in a small pilot of the revised StriveWeekly platform. Students who participate in the pilot will be invited to provide their program feedback via online surveys. Students who participate in the pilot data collection will still be eligible for the full RCT study, but may be excluded from the final data analysis sample.

Pragmatic trial design. For a trial design using self-guided online intervention, it is important that the design mimics intended intervention use (Fleming et al., 2018). As examples, overly stringent inclusion criteria limit generalizability, or face-to-face assessments may provide added benefit beyond the intervention itself (Fleming et al., 2018). Therefore, as much as possible our methods simulate how a real-world campus might offer online services as usual. First, we are employing cluster randomization, for reasons elaborated below. Second, participants in either condition will be allowed to access other on- or off-campus mental health services and resources; in our statistical analyses we will control for service use rather than excluding such students. Third, all data collection and participant communications will be electronic rather than in-person to: (a) include all students remote or on-campus, (b) avoid unintentionally bolstering motivation (e.g., inducing social desirability to please researchers), and (c) avoid adding barriers (e.g., time demands, concerns about privacy). Finally, survey compensation amount will be modest enough to increase participant response rates without artificially inflating adherence rates or self-reported improvement due to financial incentive.

Random assignment. Cluster randomization will be used to assign students according to their residential affiliation to the immediate intervention condition or the waitlist condition (i.e., delayed access). Although cluster randomization can introduce statistical confounds for analyzing intervention outcomes at the individual participant level, they can be preferred: (a) to avoid intervention "contamination" effects (e.g., if participants in both conditions can regularly interact and thus might exchange health-related knowledge), and (b) if it allows the intervention to be delivered as it would be in real practice (Cook, Delong, Murray, Vollmer, \& Heagerty, 2016). Moreover, the benefits of cluster randomization by residential house/dorm affiliation for this trial are crucial for the social aspects of the StriveWeekly program. For example, students will know who else is concurrently participating in the program (e.g., any of their friends in X, Y, Z house), allowing for peer-to-peer engagement. Also, this will allow for easier coordination of any optional complementary programming by residential staff at each house/dorm. A randomizer was already used to assign half the freshmen and upperclassman residential buildings to each condition.

Data collection. Prior to beginning any research procedures, students will provide their informed consent online via Qualtrics. Participants will be required to login to Qualtrics via HarvardKey Shibboleth, which will be configured to only allow currently active Harvard accounts. Once consent has been obtained for an individual student, they will be directed to an online survey for the study baseline assessment. The baseline survey will be open for two weeks. Students assigned to the intervention group will receive an access code in the email, allowing them to access the online platform and set-up their account. The intervention group will then be active for seven weeks, after which the posttest survey will open to the intervention group and waitlist group for one-two weeks. Thereafter, students who were assigned to the waitlist group will gain access to the online intervention for seven weeks. After this delayed access group completes the intervention, there will be a follow-up survey for all participants from both conditions. See timeline table below.

Being tested
StriveWeekly
Medical subject headings
Anxiety Disorders, Depression, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StriveWeeklyBehavioural

    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.

Study groups in NCT04927845
Study groupRoleWhat they receive
Immediate Intervention ConditionExperimentalParticipants 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.
Receives: Behavioral: StriveWeekly
Waitlist ConditionNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Posttest (~8 weeks)

Secondary outcomes (2)
  1. Perceived Stress Scale

    10-item self-report about subjective experiences of stress (completed via online surveys). Items are rated on a scale of 0-4 (four items are reverse scored), with higher scores indicating worse stress. Total scores range from 0-40.

    Measured: Baseline to Posttest (~8 weeks)

  2. The Warwick-Edinburgh Mental Wellbeing Scales

    A standardized 7-item scale designed to measure mental wellbeing in the general population (i.e., not necessarily clinical) and evaluate change in response to programs that aim to improve mental wellbeing. Completed via online surveys. Items are rated on a 5-point likert scale, with higher scores indicating a positive mental wellbeing and functioning. Total scores range from 7-35.

    Measured: Baseline to Posttest (~8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start19 May 2021
  3. Primary completion18 Apr 2022
  4. Study completion10 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04927845
Sponsor's protocol ID
IRB20-1337
Status last verified
Aug 2024
First submitted
9 Jun 2021
Last updated
3 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing StriveWeekly in people with Anxiety and Depressive Symptoms, run by Harvard University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Anxiety and Stress Scale (DASS-21) (time frame: Baseline to Posttest (~8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.

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