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Clinical Trials/NCT06668532
NCT06668532
Not yet recruiting
Not Applicable

Longitudinal Well-Being Study

Flourish Science, Inc.0 sites200 target enrollmentOctober 31, 2024
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Flourish Science, Inc.
Enrollment
200
Primary Endpoint
Flourishing Scale
Status
Not yet recruiting
Last Updated
last year

Overview

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
Registry
clinicaltrials.gov
Start Date
October 31, 2024
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Flourish Science, Inc.
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Flourishing Scale

Time Frame: Baseline, 6 weeks post-baseline, and 3-month follow-up

The Flourishing Scale (Diener et al., 2009) is an 8-item measure of psychological well-being. Respondents rate items from 1 ("Strongly disagree") to 7 ("Strongly agree"), yielding a total score range from 8 to 56. Higher scores indicate greater well-being and flourishing.

Depression (PHQ-8)

Time Frame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up

The PHQ-8 is an 8-item measure assessing depression severity over the past two weeks. Each item scores from 0 ("not at all") to 3 ("nearly every day"), with total scores from 0 to 24. Higher scores indicate greater depression severity.

Anxiety (GAD-7)

Time Frame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up

The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item measure assessing anxiety severity. Each item is rated from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity.

Perceived Stress (PSS-4)

Time Frame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up

The PSS-4 (Perceived Stress Scale-4) is a 4-item measure of perceived stress, rated from 0 ("never") to 4 ("very often"). Scores range from 0 to 16, with higher scores indicating greater stress.

Subcomponents of Affect Scale

Time Frame: Baseline, bi-weekly for 6 weeks (3 time points), and 3-month follow-up

The Subcomponents of Affect Scale (SAS) is an 18-item measure of affect, divided into nine positive and nine negative adjectives. Positive subscales include calm, well-being, and vigor, while negative subscales include depression, anxiety, and anger. Participants rate each adjective from 0 (not at all accurate) to 4 (extremely accurate) based on their feelings over the past two weeks. Total scores for positive and negative affect are summed from their subscales.

Resilience

Time Frame: Baseline, 6 weeks post-baseline, and 3-month follow-up

The Brief Resilience Scale (BRS; Smith et al., 2008) is a 6-item measure of stress recovery, rated from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate a stronger ability to "bounce back" after setbacks.

Secondary Outcomes

  • Loneliness(Baseline, 6 weeks post-baseline, and 3-month follow-up)
  • Social Fit(Baseline, 6 weeks post-baseline, and 3-month follow-up)
  • Perceived Cohesion(Baseline, 6 weeks post-baseline, and 3-month follow-up)
  • Expectations and Experiences of Chatbots(Baseline, 6 weeks post-baseline, and 3-month follow-up)
  • Multi-Dimensional Measure of Trust(6 weeks post-baseline, and 3-month follow-up)
  • Academic Self Efficacy(Baseline, 6 weeks post-baseline, and 3-month follow-up)
  • School Perceptions(Baseline, 6 weeks post-baseline, and 3-month follow-up)

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