NCT04361045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,631

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 21, 2020

Last Update Submit

May 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    [Time Frame: Baseline to Posttest (~8 weeks)]

Secondary Outcomes (2)

  • Program Adherence

    [Time Frame: Baseline to Posttest (~8 weeks)]

  • Program Satisfaction

    Posttest (~8 weeks)

Other Outcomes (2)

  • Subjective Happiness Scale

    [Time Frame: Baseline to Posttest (~8 weeks)]

  • Patient Health Questionnaire-9

    [Time Frame: Baseline to Posttest (~8 weeks)]

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Participants in this condition were delivered 8 weeks of online intervention modules and then were invited to complete a posttest survey.

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.

Interventions

StriveWeeklyBEHAVIORAL

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.

Also known as: The Happiness Challenge, ReBoot Camp
Intervention Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enrolled as a student at UCLA (Fall 2017 - Winter 2018)

You may not qualify if:

  • concurrent enrollment in a similar online anxiety and depression treatment study on campus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • 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.

  • Rith-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.

  • 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.

MeSH Terms

Conditions

Anxiety DisordersDepressionStress, Psychological

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Denise Chavira, PhD

    University of California, Los Angeles

    STUDY CHAIR
  • Leslie Leslie, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow and Principal Investigator

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

September 14, 2017

Primary Completion

March 18, 2018

Study Completion

March 18, 2018

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations