AnxietyNCT04361045
StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students
A study testing StriveWeekly in people with Anxiety and Depressive Symptoms, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depressive Symptoms, Stress, Psychological
- What is being tested?
- StriveWeekly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,631 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 18 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrolled as a student at UCLA (Fall 2017 - Winter 2018)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Randomized Control Trial of Online Mental Health Promotion Program for University Students
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.
- Conditions
- Anxiety, Depressive Symptoms, Stress, Psychological
- 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
Also called The Happiness Challenge, ReBoot Camp
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Participants in this condition were delivered 8 weeks of online intervention modules and then were invited to complete a posttest survey. Receives: Behavioral: StriveWeekly |
| Waitlist Condition | No intervention | Participants in this condition received no intervention content nor communications for 8 weeks and then were invited to complete a posttest survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Baseline to Posttest (~8 weeks)]
Secondary outcomes (2)
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.
Measured: [Time Frame: Baseline to Posttest (~8 weeks)]
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.
Measured: Posttest (~8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start14 Sep 2017
- Primary completion18 Mar 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,631 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Rith-Najarian, PhD, Harvard University
- Investigators
- Denise Chavira, PhD, Study chair, University of California, Los AngelesLeslie Leslie, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361045
- Sponsor's protocol ID
- 17-000761
- Status last verified
- May 2023
- First submitted
- 21 Apr 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanano M, Rith-Najarian L, Gong-Guy E, Chavira D. Motivational Variables as Moderating Effects of a Web-Based Mental Health Program for University Students: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2024 Jul 3;8:e56118. doi: 10.2196/56118.
PubMed 38959024Rith-Najarian LR, Gong-Guy E, Flournoy JC, Chavira DA. Randomized controlled trial of a web-based program for preventing anxiety and depression in university students. J Consult Clin Psychol. 2024 Jan;92(1):1-15. doi: 10.1037/ccp0000843. Epub 2023 Sep 28.
PubMed 37768633Hanano 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.
PubMed 35343901
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Online Mental Health Promotion Program for University Students
- ClinicalTrials.gov ID
- NCT04361045
- Acronym / sponsor ID
- 17-000761
- Conditions
- Anxiety, Depressive Symptoms, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,631 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: StriveWeeklyParticipants in this condition were delivered 8 weeks of online intervention modules and then were invited to complete a posttest survey. |
| Waitlist Condition | No intervention | –Participants in this condition received no intervention content nor communications for 8 weeks and then were invited to complete a posttest survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- enrolled as a student at UCLA (Fall 2017 - Winter 2018)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StriveWeeklyAlso: The Happiness Challenge, ReBoot CampThe 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. | Behavioural | Intervention Condition |
Primary outcome
Depression Anxiety and Stress Scale (DASS-21)
Time frame: [Time Frame: Baseline to Posttest (~8 weeks)]
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.
2 secondary outcomes
Program Adherence
Time frame: [Time Frame: Baseline to Posttest (~8 weeks)]
Program Satisfaction
Time frame: Posttest (~8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 38959024Hanano M, Rith-Najarian L, Gong-Guy E, Chavira D. Motivational Variables as Moderating Effects of a Web-Based Mental Health Program for University Students: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2024 Jul 3;8:e56118. doi: 10.2196/56118.
- Derived from this study: PubMed 37768633Rith-Najarian LR, Gong-Guy E, Flournoy JC, Chavira DA. Randomized controlled trial of a web-based program for preventing anxiety and depression in university students. J Consult Clin Psychol. 2024 Jan;92(1):1-15. doi: 10.1037/ccp0000843. Epub 2023 Sep 28.
- Derived from this study: PubMed 35343901Hanano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Chavira, PhD study chair
University of California, Los Angeles
Leslie Leslie, PhD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StriveWeekly in people with Anxiety and Depressive Symptoms, run by University of California, Los Angeles 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 2 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 17 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: [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?
On the ClinicalTrials.gov record for NCT04361045, which also lists 3 linked publications.
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 17 May 2023.