Longitudinal Well-Being Study

NCT06668532 | Completed

• 1 other identifier: Flourish2025-Manitoba
• Study Type: interventional
• Target: 1,137
• Locations: 1 country
• Sites: 1

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 care-as-usual 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

Conditions

Healthy

Keywords

well-being; digital; positive psychology; students

Outcome Measures

Primary Outcomes (6)

• Flourishing Scale

  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.

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

• Depression (PHQ-8)

  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.

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

• Anxiety (GAD-7)

  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.

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

• Perceived Stress (PSS-4)

  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.

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

• Subcomponents of Affect Scale

  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.

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

• Resilience

  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.

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

Secondary Outcomes (7)

• 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

Study Arms (2)

Flourish app condition

EXPERIMENTAL

Participants in this condition will gain access to the Flourish app and be instructed to use it at least twice a week for 6 weeks.

Device: Digital toolkit

Control Condition

OTHER

Participants in the control condition will not receive the Flourish intervention during the 6-week study period and will retain access to their usual mental health resources.

Other: Treatment as usual

Interventions

Treatment as usual OTHER

Participants in the control condition did not receive the Flourish intervention during the 6-week study period. Instead, they retained access to any mental health resources and support ordinarily available to them.

Control Condition

Digital toolkit DEVICE

Access to the Flourish app and instruction to use at least twice a week for 6 weeks.

Also known as: Flourish app

Flourish app condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently a student

Sponsors & Collaborators

• Flourish Science, Inc.: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: May 5, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Beginning upon submission for publication with no end date.

Locations

CA (1)