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COMPLETED
NCT07720973
NA

The Efficacy of "Inner Peak" an AI-enabled Digital Wellness App on Mental Wellness Among a Sample of University of West Indies (UWI) Mona Students

Sponsor: The University of The West Indies

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Months - Any

Study Type

INTERVENTIONAL

Enrollment

171

Start Date

2025-12-01

Completion Date

2026-06-30

Last Updated

2026-07-22

Healthy Volunteers

Yes

Interventions

DEVICE

Intervention 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.

BEHAVIORAL

Control group

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.

Locations (1)

The Faculty of Social Sciences

Kingston, Jamaica, Jamaica