Clinical trial NCT06668532: Longitudinal Well-Being Study
Official title: Longitudinal Well-Being Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: well-being
digital
positive psychology
students
Lead sponsor: Flourish Science, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of the Flourish app-a digital toolkit providing science-based well-being practices-in enhancing mental health among students. The main questions it aims to answer are:

* Does regular use of the Flourish app improve well-being, emotional resilience, and stress management?
* Is more frequent use of the Flourish app associated with greater improvements in these outcomes?

Researchers will compare outcomes between participants using the Flourish app and a control group receiving curated national mental health resources to assess the app's impact.

Participants will:

* Complete an initial 15-minute survey to establish baseline mental health
* Those in the Flourish app condition will use the app at least twice weekly, while those in the control condition will receive weekly mental health resources and reflect on their application
* Complete biweekly follow-up surveys over six weeks, with a final survey three months later


Eligibility criteria: Inclusion Criteria:

* Currently a student
* Fluent in English
* No uncontrolled mental health condition that significantly impacts daily life
* Prolific approval rate within the 95-100% range
* Minimum of 20 previous Prolific submissions

Primary outcomes:
measure: Flourishing Scale
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
measure: Depression (PHQ-8)
timeFrame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up
measure: Anxiety (GAD-7)
timeFrame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up
measure: Perceived Stress (PSS-4)
timeFrame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up
measure: Subcomponents of Affect Scale
timeFrame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up
measure: Resilience
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Secondary outcomes:
measure: Loneliness
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
measure: Social Fit
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
measure: Perceived Cohesion
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
measure: Expectations and Experiences of Chatbots
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
measure: Multi-Dimensional Measure of Trust
timeFrame: 6 weeks post-baseline, and 3-month follow-up
measure: Academic Self Efficacy
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
measure: School Perceptions
timeFrame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Other outcomes:
Locations:
Study officials:
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