HealthyNCT06668532
Longitudinal Well-Being Study
A study testing Digital toolkit and Treatment as usual in people with Healthy, run by Flourish Science, Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Digital toolkit and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,137 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently a student
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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?
Read more
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
- Being tested
- Digital toolkit, Treatment as usual
- Keywords
- well-being, digital, positive psychology, students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital toolkitDevice
Also called Flourish app
Access to the Flourish app and instruction to use at least twice a week for 6 weeks.
Treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks post-baseline, and 3-month follow-up
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks post-baseline, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start5 May 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flourish Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668532
- Sponsor's protocol ID
- Flourish2025-Manitoba
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified participant data on OSF from each study timepoint across both conditions, including all data used in our analyses.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Well-Being Study
- ClinicalTrials.gov ID
- NCT06668532
- Acronym / sponsor ID
- Flourish2025-Manitoba
- Conditions
- Healthy
- Keywords
- well-being, digital, positive psychology, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,137 participants (actual)
- Lead sponsor
- Flourish Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flourish app condition | Experimental | Device: Digital toolkitParticipants in this condition will gain access to the Flourish app and be instructed to use it at least twice a week for 6 weeks. |
| Control Condition | Other | Other: Treatment as usualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently a student
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital toolkitAlso: Flourish appAccess to the Flourish app and instruction to use at least twice a week for 6 weeks. | Device | Flourish app condition |
| Treatment as usualParticipants 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. | Other | Control Condition |
Primary outcome
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.
7 secondary outcomes
Loneliness
Time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Social Fit
Time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Perceived Cohesion
Time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Expectations and Experiences of Chatbots
Time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Multi-Dimensional Measure of Trust
Time frame: 6 weeks post-baseline, and 3-month follow-up
Academic Self Efficacy
Time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up
School Perceptions
Time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. We will share de-identified participant data on OSF from each study timepoint across both conditions, including all data used in our analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital toolkit and Treatment as usual in people with Healthy, run by Flourish Science, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flourishing Scale (time frame: Baseline, 6 weeks post-baseline, and 3-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.