Mental Health Wellness 1Wellness AppNCT07720973
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
A study testing Intervention Group in people with Mental Health Wellness 1, run by The University of The West Indies at 1 site in Jamaica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Intervention Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Dec 2025to 30 Jun 2026
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background
Since the COVID-19 pandemic, many countries are facing a new epidemic of loneliness, anxiety, and depression. These rates are more prevalent among the more youthful population with recent research surveying 80,000 youth globally indicating that depressive and anxiety symptoms have doubled during the pandemic, with 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms. These statistics are even more stunning in some countries, as in the United States in 2021, 60% of college students surveyed across 370+ schools met the medical criteria to be diagnosed with a mental health challenge. This has a tremendous impact on student graduation rates, as students with a mental health challenge are three times as likely to drop out than students without mental health issues. Universities are losing top-line revenue as a result of student mental health, making mental health a top university concern.
Jamaica is not immune to these mental health challenges as according to the Jamaican Ministry of Health and Wellness, in 2016, 14% of Jamaicans experienced depression (NCPID). Though there have not been reliable reports conducted since the pandemic, if Jamaica followed the average global trend, upwards of 30-35% of the population would have experienced depression. Jamaica's limited economic resources make meeting physical and mental health needs extremely challenging. The patient to psychiatrist ratio in Jamaica is 100,000:1, and there are even fewer psychologists, with 1 for every 300,000 potential patients. Low mental health literacy further compounds these challenges. Further, various demographic factors such as gender, socio-economic factors, accessibility of resources, among others have been found to impact health-seeking behaviours among Jamaicans.
These barriers have necessitated healthcare professionals to consider innovative interventions that are accessible, effective, and tailored to the unique needs of Jamaicans. The University of the West Indies, one of the leading tertiary institutions in the Caribbean, is known for its contribution to healthcare interventions in Jamaica. The university acts as a microcosm of Jamaican society with indications of mental health challenges such as depression, trauma, anxiety, disordered eating behaviours prior to and more so since the pandemic.
The University's Health Center (UHC) is the designated facility to meet both the mental and physical needs of the university population. The UHC at the University of the West Indies, Mona Campus (UWI - Mona) provides a wide range of primary and secondary health care services to members of the university community, including staff and their dependents, retirees and their spouses, students and at times visiting groups.
Traditional face-to-face psychological intervention comes with its own set of challenges, including but not limited to stigma associated with getting psychological treatment; confidentiality; long waitlist or being seen long after the initial request to be seen; financial challenges in accessing care; or a lack of awareness of the resources available and the reliance self to fix one's problems, which is particularly common among young people.
Jamaica faces these problems even more acutely due to a lack of economic resources and mental health providers. UWI Mona Campus is a microcosm of these issues, as the ratio of mental health providers to students is only 1:3,500. This ratio is in practice even worse, as it does not include members of staff, current and those retired, who are also seen by the University of the West Indies, Health Centre. The International Association of College Counselors recommends that campuses maintain minimum staffing ratios in the range of one full-time professional staff member to every 1,000 students. The current cadre of 4 counselors (including the head of the UHC) is short-staffed, leading to long delays in new and follow-up appointments which can be upwards of 6-8 weeks. To meet international standards, UWI Mona would have to hire 10 more full-time counselors, entirely impractical given budget constraints.
Research advocates for using online interventions (which can include digital mental health apps, such as Headspace and Calm) to supplement traditional counseling to meet client needs. These solutions are helpful because they are available 24/7, less costly, and scale to many students at the same time. Further, online intervention programmes have the option to compile data to monitor, evaluate and improve their programme delivery and efficiency. Studies have also indicated that, when these apps are used regularly, they can be effective for users in improving mindfulness, well-being, stress, depressive symptoms, self-harm, eating disorders, sleep disturbances and anxiety symptoms. However, these solutions struggle to keep users engaged and retain them long enough to have an impact. A systematic review of 93 apps with 10,000 installs or more targeting anxiety, depression, or emotional wellbeing showed the median 15-day and 30-day retention rates were 3.9% and 3.3% respectively. Further, these apps are designed to teach a skill in the abstract, not address a specific challenge a client is facing. This suggests that the apps are not situationally relevant and deliver solutions linearly in the same way for each user, or require the user to have the knowledge to search for a specific piece of content to solve an issue.
To successfully meet student mental health needs, the world requires affordable, scalable, and effective interventions that also promote sustained user engagement, ensuring that students utilize the solution sufficiently to derive meaningful benefits. One way to keep students using something is to create accountability through a working alliance. This working alliance between a therapist and patient is the best predictor of success in the therapeutic relationship. Artificial Intelligence (AI) conversational agents can be used in therapeutic capacities to build a working alliance of similar strength to a human therapist working alliance. While this seems counterintuitive at first, AIs at baseline show unconditional positive regard and are non-judgemental, the core attributes of any good patient therapist alliance. Furthermore, AIs are tireless. In fact, researchers found that AI responses to patient questions on an online forum were preferred over actual medical professionals' answers as they rated significantly higher for empathy and quality. Taken together, this research suggests that AI can play a role in human connection and relationships.
"Accountability partner" behavior has its roots in Alcoholics Anonymous' practice of pairing each person with a sponsor with whom they have regular meetings and who encourages their sobriety. The American Society of Training and Development did a study on accountability and found that participants had a 65% chance of completing a goal if they committed to that goal to someone else. If participants had a specific accountability appointment with a person to whom they have committed, they increased their chance of success by up to 95%.
Since AI can mimic a human relationship, this suggests that AI can potentially be used to drive accountability to goals, including continued usage of digital mental health tools. This suggests that AI conversational agents can be used to help keep users engaged. Many young adults and college students are open to seeking anonymous mental health support from a conversational agent. In a recent survey, 55% of 18-29 year olds indicated that they would be more comfortable speaking with an AI conversational agent than a human therapist.
Relying solely on AI has its drawbacks. Because AI technology moves so quickly, there is little academic research identifying the drawbacks. Instead, investigators must turn to examples in the news. One of the examples that evidences the danger of AI is the tragedy of a 14-year-old boy who used a Character AI chatbot that did not have appropriate guardrails in place. When given the leeway to provide the user advice, the chatbot encouraged the boy to take his own life, which he did. Because AI can hallucinate, it is not good at being an expert itself. However, it is very good at identifying patterns and directing a user to the appropriate expert.
The Inner Peak mental wellness app was designed to bridge the gaps in these solutions. The use of digital apps for mental health and wellness is common. The intention of the Inner Peak app is to complement psychotherapy; it is not a replacement for a therapist to treat mental illness. It was designed, like other digital apps, as a guided self-help tool. These other apps are shown to offer scalable, easy-to-access, timely solutions to improve quality of self-care and self-management. It starts from the same core of expert-created digital content as the other digital interventions, but wraps this content in an engaging, personalized, 24/7 accountability partner in the AI coach. AI coaches and therapists have been shown to drive greater engagement over a longer period than using solely videos. A combination of AI coaches with digital content has never been tested academically. The investigators hypothesize that restricting the role of the coaches to active listeners and content curators, as in the Inner Peak app, can prevent some of the dangers of using AI while still realizing the increased engagement, personalization, and accessibility benefits of AI. The reference made to a "guardrailed" AI conversational agent in this study means: using AI only as an active listener as opposed to an advisor or expert. This study will assess whether an AI conversational agent can still achieve desired mental health outcomes if it is only allowed to be an active listener and curator of content.
Justification:
Prior research has tested and demonstrated the effectiveness of using digital therapist-created content in mobile and web applications, but has highlighted that the biggest challenge of this method is encouraging continued usage of the resources. User attrition greatly reduces the effectiveness of these solutions. In order to improve effectiveness and reduce attrition, apps that involve a relational element (generally human, but sometimes AI) drive greater usage. Given that researchers are unable to use humans because of limited resources, an app that uses AI in this context can address this challenge. AI on its own however can be harmful if it makes a recommendation to a user that is incorrect. An app which has combined AI with content already created by expert therapists is deemed to be the best solution for driving higher engagement and effectiveness.
Research has also indicated that when people engage with human therapists or AI therapists, they are much more likely to continue engagement over longer periods of time allowing greater potential for impact. While it may be preferential to use humans over AI, AI becomes a more viable interim alternative especially in lower-income countries or places with lower concentrations of therapists and lack of resources to meet the mental health needs of its population. An observational study of 10 apps that offer support and treatment for a variety of mental health concerns with a built-in chatbot feature concluded that "chatbots have great potential to offer social and psychological support in situations where real-world human interaction is not preferred or possible to achieve. To build on this finding, the investigators propose an experimental design to test the actual effectiveness of the Inner Peak chatbot beyond just user reviews."
Because AI technology is advancing so quickly, there is limited research testing different ways of applying it. In this study, the investigators will test whether AI that is limited in its role to solely being an active listener and content curator can still drive better continued usage and outcomes while reducing risk of AI providing inaccurate advice that might be dangerous to users.
Given the lack of resources, along with the long wait period to gain support from a therapist, AI may provide some support for college students in this low and middle income country. Additionally, the investigators would like to ensure that the type of app used is one that is deemed to address any previous limitations found with other app. This study therefore seeks to bridge this gap by examining this newly generated AI mental wellness support app among a sample of university students, their use of it and how they engage with it. Findings from this study may provide useful insight into other forms of support, especially among populations that have been unable or unwilling to receive mental health support from mental health professionals.
Hypothesis:
Using a guardrailed AI conversational agent that curates therapist-created video content in a mental wellness app will improve mental health attitudes and outcomes in UWI students.
Objectives:
- To describe the mental wellness challenges students are experiencing (and the frequency of these challenges) that prompt them to utilize a new guardrailed AI-powered mental wellness resource. ii. To measure whether students enjoyed using guardrailed AI for their mental health and felt more emotionally supported and safer by having access to the app. iii. To assess whether giving students access to a guardrailed AI-powered mental wellness resource can increase student understanding of their mental health and confidence in their ability to improve their own mental health on their own or with AI-powered tools. iv. To determine if using guardrailed AI to support student mental health can improve wellbeing outcomes as measured by self-reported clinically validated scales.
- Conditions
- Mental Health Wellness 1
- Being tested
- Intervention Group, Control group
- Keywords
- wellness app, university students, 18 years and older, Jamaica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupDevice
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.
Control groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intervention Group; Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Dec 2025
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- George Mason University
- Responsible party
- Principal investigator, CARYL JAMES, The University of The West Indies
- Investigators
- Caryl James, PhD, Principal investigator, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720973
- Sponsor's protocol ID
- CREC-MN.0140,2024/2025
- Acronym
- Wellness App
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying information will be given, just the outcomes of the study.
Publications
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.
PubMed 31890625Donker 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.
PubMed 24240579Darcy 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.
PubMed 33973854Bourne, 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?
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.
PubMed 31573916American 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07720973
- Acronym / sponsor ID
- Wellness App / CREC-MN.0140,2024/2025
- Conditions
- Mental Health Wellness 1
- Keywords
- wellness app, university students, 18 years and older, Jamaica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- George Mason University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Jul 2026 (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.
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.
Detailed description
Background
Since the COVID-19 pandemic, many countries are facing a new epidemic of loneliness, anxiety, and depression. These rates are more prevalent among the more youthful population with recent research surveying 80,000 youth globally indicating that depressive and anxiety symptoms have doubled during the pandemic, with 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms. These statistics are even more stunning in some countries, as in the United States in 2021, 60% of college students surveyed across 370+ schools met the medical criteria to be diagnosed with a mental health challenge. This has a tremendous impact on student graduation rates, as students with a mental health challenge are three times as likely to drop out than students without mental health issues. Universities are losing top-line revenue as a result of student mental health, making mental health a top university concern.
Jamaica is not immune to these mental health challenges as according to the Jamaican Ministry of Health and Wellness, in 2016, 14% of Jamaicans experienced depression (NCPID). Though there have not been reliable reports conducted since the pandemic, if Jamaica followed the average global trend, upwards of 30-35% of the population would have experienced depression. Jamaica's limited economic resources make meeting physical and mental health needs extremely challenging. The patient to psychiatrist ratio in Jamaica is 100,000:1, and there are even fewer psychologists, with 1 for every 300,000 potential patients. Low mental health literacy further compounds these challenges. Further, various demographic factors such as gender, socio-economic factors, accessibility of resources, among others have been found to impact health-seeking behaviours among Jamaicans.
These barriers have necessitated healthcare professionals to consider innovative interventions that are accessible, effective, and tailored to the unique needs of Jamaicans. The University of the West Indies, one of the leading tertiary institutions in the Caribbean, is known for its contribution to healthcare interventions in Jamaica. The university acts as a microcosm of Jamaican society with indications of mental health challenges such as depression, trauma, anxiety, disordered eating behaviours prior to and more so since the pandemic.
The University's Health Center (UHC) is the designated facility to meet both the mental and physical needs of the university population. The UHC at the University of the West Indies, Mona Campus (UWI - Mona) provides a wide range of primary and secondary health care services to members of the university community, including staff and their dependents, retirees and their spouses, students and at times visiting groups.
Traditional face-to-face psychological intervention comes with its own set of challenges, including but not limited to stigma associated with getting psychological treatment; confidentiality; long waitlist or being seen long after the initial request to be seen; financial challenges in accessing care; or a lack of awareness of the resources available and the reliance self to fix one's problems, which is particularly common among young people.
Jamaica faces these problems even more acutely due to a lack of economic resources and mental health providers. UWI Mona Campus is a microcosm of these issues, as the ratio of mental health providers to students is only 1:3,500. This ratio is in practice even worse, as it does not include members of staff, current and those retired, who are also seen by the University of the West Indies, Health Centre. The International Association of College Counselors recommends that campuses maintain minimum staffing ratios in the range of one full-time professional staff member to every 1,000 students. The current cadre of 4 counselors (including the head of the UHC) is short-staffed, leading to long delays in new and follow-up appointments which can be upwards of 6-8 weeks. To meet international standards, UWI Mona would have to hire 10 more full-time counselors, entirely impractical given budget constraints.
Research advocates for using online interventions (which can include digital mental health apps, such as Headspace and Calm) to supplement traditional counseling to meet client needs. These solutions are helpful because they are available 24/7, less costly, and scale to many students at the same time. Further, online intervention programmes have the option to compile data to monitor, evaluate and improve their programme delivery and efficiency. Studies have also indicated that, when these apps are used regularly, they can be effective for users in improving mindfulness, well-being, stress, depressive symptoms, self-harm, eating disorders, sleep disturbances and anxiety symptoms. However, these solutions struggle to keep users engaged and retain them long enough to have an impact. A systematic review of 93 apps with 10,000 installs or more targeting anxiety, depression, or emotional wellbeing showed the median 15-day and 30-day retention rates were 3.9% and 3.3% respectively. Further, these apps are designed to teach a skill in the abstract, not address a specific challenge a client is facing. This suggests that the apps are not situationally relevant and deliver solutions linearly in the same way for each user, or require the user to have the knowledge to search for a specific piece of content to solve an issue.
To successfully meet student mental health needs, the world requires affordable, scalable, and effective interventions that also promote sustained user engagement, ensuring that students utilize the solution sufficiently to derive meaningful benefits. One way to keep students using something is to create accountability through a working alliance. This working alliance between a therapist and patient is the best predictor of success in the therapeutic relationship. Artificial Intelligence (AI) conversational agents can be used in therapeutic capacities to build a working alliance of similar strength to a human therapist working alliance. While this seems counterintuitive at first, AIs at baseline show unconditional positive regard and are non-judgemental, the core attributes of any good patient therapist alliance. Furthermore, AIs are tireless. In fact, researchers found that AI responses to patient questions on an online forum were preferred over actual medical professionals' answers as they rated significantly higher for empathy and quality. Taken together, this research suggests that AI can play a role in human connection and relationships.
"Accountability partner" behavior has its roots in Alcoholics Anonymous' practice of pairing each person with a sponsor with whom they have regular meetings and who encourages their sobriety. The American Society of Training and Development did a study on accountability and found that participants had a 65% chance of completing a goal if they committed to that goal to someone else. If participants had a specific accountability appointment with a person to whom they have committed, they increased their chance of success by up to 95%.
Since AI can mimic a human relationship, this suggests that AI can potentially be used to drive accountability to goals, including continued usage of digital mental health tools. This suggests that AI conversational agents can be used to help keep users engaged. Many young adults and college students are open to seeking anonymous mental health support from a conversational agent. In a recent survey, 55% of 18-29 year olds indicated that they would be more comfortable speaking with an AI conversational agent than a human therapist.
Relying solely on AI has its drawbacks. Because AI technology moves so quickly, there is little academic research identifying the drawbacks. Instead, investigators must turn to examples in the news. One of the examples that evidences the danger of AI is the tragedy of a 14-year-old boy who used a Character AI chatbot that did not have appropriate guardrails in place. When given the leeway to provide the user advice, the chatbot encouraged the boy to take his own life, which he did. Because AI can hallucinate, it is not good at being an expert itself. However, it is very good at identifying patterns and directing a user to the appropriate expert.
The Inner Peak mental wellness app was designed to bridge the gaps in these solutions. The use of digital apps for mental health and wellness is common. The intention of the Inner Peak app is to complement psychotherapy; it is not a replacement for a therapist to treat mental illness. It was designed, like other digital apps, as a guided self-help tool. These other apps are shown to offer scalable, easy-to-access, timely solutions to improve quality of self-care and self-management. It starts from the same core of expert-created digital content as the other digital interventions, but wraps this content in an engaging, personalized, 24/7 accountability partner in the AI coach. AI coaches and therapists have been shown to drive greater engagement over a longer period than using solely videos. A combination of AI coaches with digital content has never been tested academically. The investigators hypothesize that restricting the role of the coaches to active listeners and content curators, as in the Inner Peak app, can prevent some of the dangers of using AI while still realizing the increased engagement, personalization, and accessibility benefits of AI. The reference made to a "guardrailed" AI conversational agent in this study means: using AI only as an active listener as opposed to an advisor or expert. This study will assess whether an AI conversational agent can still achieve desired mental health outcomes if it is only allowed to be an active listener and curator of content.
Justification:
Prior research has tested and demonstrated the effectiveness of using digital therapist-created content in mobile and web applications, but has highlighted that the biggest challenge of this method is encouraging continued usage of the resources. User attrition greatly reduces the effectiveness of these solutions. In order to improve effectiveness and reduce attrition, apps that involve a relational element (generally human, but sometimes AI) drive greater usage. Given that researchers are unable to use humans because of limited resources, an app that uses AI in this context can address this challenge. AI on its own however can be harmful if it makes a recommendation to a user that is incorrect. An app which has combined AI with content already created by expert therapists is deemed to be the best solution for driving higher engagement and effectiveness.
Research has also indicated that when people engage with human therapists or AI therapists, they are much more likely to continue engagement over longer periods of time allowing greater potential for impact. While it may be preferential to use humans over AI, AI becomes a more viable interim alternative especially in lower-income countries or places with lower concentrations of therapists and lack of resources to meet the mental health needs of its population. An observational study of 10 apps that offer support and treatment for a variety of mental health concerns with a built-in chatbot feature concluded that "chatbots have great potential to offer social and psychological support in situations where real-world human interaction is not preferred or possible to achieve. To build on this finding, the investigators propose an experimental design to test the actual effectiveness of the Inner Peak chatbot beyond just user reviews."
Because AI technology is advancing so quickly, there is limited research testing different ways of applying it. In this study, the investigators will test whether AI that is limited in its role to solely being an active listener and content curator can still drive better continued usage and outcomes while reducing risk of AI providing inaccurate advice that might be dangerous to users.
Given the lack of resources, along with the long wait period to gain support from a therapist, AI may provide some support for college students in this low and middle income country. Additionally, the investigators would like to ensure that the type of app used is one that is deemed to address any previous limitations found with other app. This study therefore seeks to bridge this gap by examining this newly generated AI mental wellness support app among a sample of university students, their use of it and how they engage with it. Findings from this study may provide useful insight into other forms of support, especially among populations that have been unable or unwilling to receive mental health support from mental health professionals.
Hypothesis:
Using a guardrailed AI conversational agent that curates therapist-created video content in a mental wellness app will improve mental health attitudes and outcomes in UWI students.
Objectives:
- To describe the mental wellness challenges students are experiencing (and the frequency of these challenges) that prompt them to utilize a new guardrailed AI-powered mental wellness resource. ii. To measure whether students enjoyed using guardrailed AI for their mental health and felt more emotionally supported and safer by having access to the app. iii. To assess whether giving students access to a guardrailed AI-powered mental wellness resource can increase student understanding of their mental health and confidence in their ability to improve their own mental health on their own or with AI-powered tools. iv. To determine if using guardrailed AI to support student mental health can improve wellbeing outcomes as measured by self-reported clinically validated scales.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Group | Experimental | Device: Intervention Group, Behavioral: Control groupThis 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. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Participants will be excluded if they
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 |
|---|---|---|
| Intervention GroupThis 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 | Device Group |
| Control groupThe 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. | Behavioural | Device Group |
Primary outcome
Improvement in mental wellbeing
Time frame: 2 weeks and 4 weeks
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)
Improvement in mental wellbeing
Time frame: 2 weeks and 4 weeks
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)
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 24 Jul 2026.
- Background: PubMed 31890625Farrer 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.
- Background: PubMed 24240579Donker 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.
- Background: PubMed 33973854Darcy 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.
- BackgroundBourne, 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: PubMed 31573916Baumel 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.
- BackgroundAmerican 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
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No identifying information will be given, just the outcomes of the study.
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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.
Caryl James, PhD principal investigator
The University of The West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Mental Health Wellness 1, run by The University of The West Indies at 1 site in Jamaica.
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 3 inclusion and 4 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 24 Jul 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 Jamaica. 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?
Improvement in mental wellbeing (time frame: 2 weeks and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07720973, which also lists 6 linked publications.
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 24 Jul 2026.