Longitudinal Well-Being Study

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Digital toolkit; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 1137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Currently a student

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flourish app condition; 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; Access to the Flourish app and instruction to use at least twice a week for 6 weeks.; Other Names: Flourish app
Other: Control Condition; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	The UCLA 3-Item Loneliness Scale is a brief measure assessing subjective feelings of loneliness and social isolation. Participants rate each item on a 3-point scale, from 1 (hardly ever) to 3 (often), with higher scores indicating greater loneliness.	Baseline, 6 weeks post-baseline, and 3-month follow-up
Social Fit	The Sense of Social Fit Scale (Walton & Cohen, 2007) measures students' perceived belonging within their school environment. For our purposes, we used a shortened version with two items: "I fit in well at my school" and "Other people understand more than I do about what is going on at my school," rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).	Baseline, 6 weeks post-baseline, and 3-month follow-up
Perceived Cohesion	The Perceived Cohesion Scale (Bollen & Hoyle, 1990) measures a sense of belonging and morale within a community using a Likert scale from 0 (strongly disagree) to 10 (strongly agree). For our purposes, we use a single-item version: "I see myself as part of the campus community."	Baseline, 6 weeks post-baseline, and 3-month follow-up
Expectations and Experiences of Chatbots	This measure, adapted from the Working Alliance Inventory - Short Revised (WAI-SR), assesses participants' expectations and experiences with chatbots. Participants rate anticipated and actual interactions across three areas-Goal, Task, and Bond-on a 5-point scale from 1 (seldom) to 5 (always), with higher scores indicating stronger alignment.	Baseline, 6 weeks post-baseline, and 3-month follow-up
Multi-Dimensional Measure of Trust	The Multi-Dimensional Measure of Trust (MDMT; Ullman & Malle, 2023) assesses perceived trustworthiness of the Flourish chatbot, Sunnie, through a set of 10 attributes (Form A), rated from 0 (Not at all) to 5 (Very), with a 'Does Not Fit' option. Only participants in the Flourish app condition complete this measure.	6 weeks post-baseline, and 3-month follow-up
Academic Self Efficacy	The Academic Self-Efficacy scale (van Zyl et al., 2022) measures students' confidence in their ability to succeed academically. Participants rate their agreement with statements such as "I generally manage to solve difficult academic problems if I try hard enough" on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater self-belief in tackling academic challenges and achieving study-related goals.	Baseline, 6 weeks post-baseline, and 3-month follow-up
School Perceptions	School perceptions are measured using two single-item measures from the Healthy Minds Survey, along with an adapted Inclusion of Other in the Self (IOS) scale to capture closeness to the university. The first item rates agreement with the statement, "At my school, students' mental and emotional well-being is a priority," on a scale from 1 (strongly agree) to 6 (strongly disagree). The second item rates satisfaction with the overall school experience from 1 (very dissatisfied) to 6 (very satisfied). For university closeness, participants select one image from a series of overlapping circles that best represents their relationship with the university, with greater overlap indicating a stronger connection.	Baseline, 6 weeks post-baseline, and 3-month follow-up

Collaborators and Investigators

• Sponsor: Flourish Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: well-being; students; positive psychology; digital
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: Flourish2025-Manitoba

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified participant data on OSF from each study timepoint across both conditions, including all data used in our analyses.
• IPD Sharing Time Frame: Beginning upon submission for publication with no end date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No