NCT07720973

Brief Summary

This study aims to test the efficacy of therapist-created video content delivered by an Artificial Intelligence (AI) conversational agent and recommendation algorithms (as in the Inner Peak app) among a sample of University of the West Indies, Mona (UWI) students in Jamaica for four weeks. Additionally, we aim to assess if relational accountability and increased users' re-engagement over time will improve mental wellbeing in comparison to a no intervention control group with self-report psychological measures on wellbeing, stress, anxiety and depression. Using a randomized controlled trial on a sample of consented university student volunteers 18 years and older, we sought to ascertain if engagement with an AI-enabled, video content-based mental wellness app will improve mental well-being and other psychological outcomes. In the study, a control group will receive email reminders about existing university mental health resources bi-weekly for 4 weeks. The treatment group will receive access to the Inner Peak mobile application, as well as instructions for how to use it. At the end of the study all participants will be provided with optional access to Inner Peak (waitlist control condition). Using a power analysis a sample of 400 was calculated. Participants' responses will be anonymized using a unique encrypted key in a data protected account. Data collection will extend from December 2025 - July 2026. The encrypted data will be stored on a password-protected Google Drive account, with access limited to designated researchers. Data will be destroyed 5 years after it has been collected. Outcome metrics will include increased re-engagement with the app and improvement in wellbeing, stress, anxiety, and depression. The study will use two clinically validated scales: the 14-item Warwick Edinburgh Mental Wellbeing Scale and the 21-item Depression, Anxiety, and Stress Scale. Descriptive statistics will be used to describe variables: means and standard deviations for continuous variables; frequencies and proportions for categorical variables. T-tests, correlation, and regression analyses will be used to determine the nature and strength of association between specific factors and outcome variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 15, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

wellness appuniversity students18 years and olderJamaica

Outcome Measures

Primary Outcomes (2)

  • Improvement in mental wellbeing

    Pre and post test differences of improvement in wellbeing will be measured through self-reported, clinically validated scales-higher scores on the 14-item Warwick - Edinburgh Wellbeing Scale and lower scores on 21-item Depression Anxiety Stress Scale (DASS-21)

    2 weeks and 4 weeks

  • Improvement in mental wellbeing

    Pre and post test differences of improvement in wellbeing as indicated by a reduction of the scores on self report measure of the 21-item Depression Anxiety Stress Scale (DASS-21)

    2 weeks and 4 weeks

Study Arms (1)

Device Group

EXPERIMENTAL

This group is the only group that will receive access to the Inner Peak wellness app. The treatment group will receive a link to a video (and transcript) that describes the resources, as the control group's video, but with the addition of the Inner Peak resource. As part of the consent process to use the app, when students create an account, they will be asked to affirm that they will be the only one using the account from their phone. They will be directed to the questionnaires on wellbeing at baseline, assessed at 2 weeks and then at week 4. Students consent to the Inner Peak Terms of Service and Privacy Policy as part of onboarding to the app. Students must explicitly accept that if their lives or the lives of someone else might be in danger, their information can be shared with healthcare administrators at their school.

Device: Intervention GroupBehavioral: Control group

Interventions

Control groupBEHAVIORAL

The control group will receive an email or QR code with an informed consent form outlining the purpose and details of the study, confidentiality and privacy of their responses and their right to withdraw their participation if they so desire, without the risk of penalty. Instructions will be given that once they submit the form they are consenting to participate. They will be directed to The 14-Item Warwick Edinburgh Wellbeing Scale and the DASS-21 will be assessed at baseline, assessed at 2 weeks and then at week 4 (that is, baseline, week-2 and week-4).The control group will receive an email with a link to a video (as well as a transcript of the video). The video will explain university mental health and wellness resources and how to access them. After the control group completes the post-study survey (that is the 14-item Warwick Edinburgh Wellbeing Scale and DASS-21), they will then receive the same access to the app the treatment group received.

Device Group

This group in addition to completing the consent form and the questionnaires as the control group, they are the only group that will receive access to the Inner Peak wellness app. The treatment group will receive a link to a video (and transcript) that describes the resources as the control group's video, but with the addition of the Inner Peak resource. As part of the consent process to use the app, when students create an account, they will be asked to affirm that they will be the only one using the account from their phone. They will be directed to the questionnaires on wellbeing at baseline, assessed at 2 weeks and then at week 4. Students consent to the Inner Peak Terms of Service and Privacy Policy as part of onboarding to the app. Students must explicitly accept that if their lives or the lives of someone else might be in danger, their information can be shared with healthcare administrators at their school.

Device Group

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • University of West Indies students aged 18+ who have signed our consent form.
  • Have access to an Android or Apple Device
  • Have a UWI email account

You may not qualify if:

  • Participants will be excluded if they
  • Are below the age of 18
  • Have not given written consent to participate
  • Do not attend UWI at the time of consenting to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Faculty of Social Sciences

Kingston, Jamaica, Jamaica

Location

Related Publications (6)

  • Farrer LM, Gulliver A, Katruss N, Fassnacht DB, Kyrios M, Batterham PJ. A novel multi-component online intervention to improve the mental health of university students: Randomised controlled trial of the Uni Virtual Clinic. Internet Interv. 2019 Aug 28;18:100276. doi: 10.1016/j.invent.2019.100276. eCollection 2019 Dec.

    PMID: 31890625BACKGROUND
  • Donker T, Petrie K, Proudfoot J, Clarke J, Birch MR, Christensen H. Smartphones for smarter delivery of mental health programs: a systematic review. J Med Internet Res. 2013 Nov 15;15(11):e247. doi: 10.2196/jmir.2791.

    PMID: 24240579BACKGROUND
  • Darcy A, Daniels J, Salinger D, Wicks P, Robinson A. Evidence of Human-Level Bonds Established With a Digital Conversational Agent: Cross-sectional, Retrospective Observational Study. JMIR Form Res. 2021 May 11;5(5):e27868. doi: 10.2196/27868.

    PMID: 33973854BACKGROUND
  • Bourne, P. A., Brown, C., Lawson, Z., Williams, S., Thompson, L., Fallah, J., Campbell, C.,Foster, C., McClean, C., Russell Parkes, D & Muchee, T. (2022). Is there a Relationship between Tolerance and the Healthcare Seeking Behaviours of Jamaicans?

    BACKGROUND
  • Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567.

    PMID: 31573916BACKGROUND
  • American Psychological Association. (2022, October). Mental health on campus: More care needed. APA Monitor on Psychology. https://www.apa.org/monitor/2022/10/mental-health- campus-care

    BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Caryl James, PhD

    The University of The West Indies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Eating Disorders, Body Image and Mental Health

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 22, 2026

Study Start

December 1, 2025

Primary Completion

May 30, 2026

Study Completion

June 30, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

No identifying information will be given, just the outcomes of the study.

Locations