iWellness Study to Evaluate a Mental Health App for Students
NCT ID: NCT05234970
Last Updated: 2023-03-07
Study Results
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Basic Information
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COMPLETED
NA
289 participants
INTERVENTIONAL
2022-02-24
2022-12-31
Brief Summary
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Detailed Description
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Specific Aims:
This study aims to evaluate the effectiveness of a mental health app to improve symptoms of depression and anxiety for students compared to treatment as usual.
In our pilot study, the investigators limited recruitment to students waiting for an initial appointment at Harvard University Health Services (HUHS) Counseling and Mental Health Services (CAMHS). In this trial, the investigators will broaden enrollment to include students seeking care at CAMHS as well as students who are not currently enrolled in treatment but who could benefit from additional mental health support.
In addition, in the full trial, the investigators will explore mediators of change, including perceived stress and isolation, through which a Cognitive Behavioral Therapy (CBT)-based Chatbot app ("Wysa") may contribute to improvement in depression and anxiety among students.
This will also involve exploring possible moderators of the effect such as students' demographic characteristics, concurrent or previous mental health treatment, and degree of usage of the mobile app.
The mobile mental health app will not be offered as a replacement for treatment at HUHS CAMHS but as a way of offering initial support and a potential gateway to seeking further treatment. In addition, the app is intended to promote mental wellness as using the app will help give students skills that may prevent them from needing further mental health treatment. For those with active symptoms, it is meant to increase students' interest in engaging with mental health services.
This study will make a significant and novel contribution to research in college mental health regarding the effectiveness of mobile mental health applications in the college population. Additionally, it will help provide understanding of the mediators of this effect and whether an innovative tool such as a CBT chatbot app can be used to promote mental wellness, prevent worsening mental health symptoms and increase uptake with other mental health related services for students who are not engaged in traditional treatment.
The investigators propose to address the following aims:
Aim 1: Evaluate the use of a CBT-based mobile Chatbot app ("Wysa") to improve outcomes of depression and anxiety for students compared to treatment as usual as measured by improvement in PHQ-9 and GAD-7 scores.
Hypothesis 1: Participants randomly assigned to the intervention will be more likely to report improved anxiety and depression outcomes, assessed after the intervention, compared to the participants randomly assigned to the control group (Cohen d = 0.4).
Aim 2: Assess the potential mediators of change for a CBT-based Chatbot app ("Wysa") to improve depression and anxiety.
Hypothesis 2: Perceived stress and social isolation will be identified as potential mediators of the relationship between the intervention and depression and anxiety.
Background and Significance
Untreated or under-treated depression and anxiety in college-age students has tremendous costs for the individual, the larger community and society at large, with the fatal outcome of suicide leading to devastating consequences for college communities. The frequency that students report having seriously considered suicide has increased by almost 40% in the last five years and the demand for counseling services has also grown five times faster than average student enrollment. Technological innovations such as mobile apps hold promise to improve access to care, allow students to seek care in a way that is potentially more comfortable for them, and to alleviate demand on over-burdened service centers. However, there is limited evidence on the effectiveness, feasibility of use and mechanisms by which these mobile platforms may improve mental health outcomes. Consequently, there is a pressing need to further research the use of mobile apps in this population to improve care and inform novel treatment approaches.
Considering the ubiquity of mobile phone usage in this population-98% of young adults aged 18-29 own a smartphone -there is significant interest in the use of mobile phone apps as an alternate care delivery platform. Additionally, the number of mobile mental health apps is exponentially growing with currently thousands of mental health apps available. Mobile apps have the potential to reach people outside of the traditional care model and allow people to use these tools when they need them, and as often as they like without having to wait for a mental health professional. Additionally, mobile health applications offer advantages such as continuous availability and immediate support, anonymity, customizable content and self-guided treatment approaches. These tools have also been seen as ways to increase service capacity and efficiency, reduce other barriers to face-to-face help seeking such as stigma and shame, and may be particularly well suited to young people who may be more accepting of technological approaches.
However, the evidence base for the efficacy of digital technologies for the mental health of college students remains unclear and research is significantly lagging behind app development. A systematic review found that even though many studies found that digital mental health interventions were effective, about half of the studies failed to present any usability or acceptability outcomes. They found that further research on user experience and engagement would be vital to the success of digital mental health interventions on college campuses. Furthermore, another study found that the largest problem for top-ranked apps for depression was attrition; the value of an AI-based chatbot lies in its ability to respond real-time to a user's inputs. Lastly, a scoping systematic review focused specifically on mental digital health platforms for university students found that students worldwide were prepared to engage with digital mental health interventions but placed a high emphasis on a need for reliable devices handling their sensitive data.
This study seeks to advance the initial findings from our pilot study and address current gaps in the literature. By selecting an interactive, AI-chatbot app, our study also aims to explore the role of an innovative approach to providing mental health resources and improving mental wellness for students.
Research Design
This is a randomized controlled trial conducted fully digitally to evaluate the effectiveness of a mobile chatbot app to alleviate symptoms of depression and anxiety in students.
Methods
Recruitment and Screening This trial will include a broad recruitment strategy with a focus on mental health promotion. Students who are both engaged in treatment at HUHS and those who are not engaged in treatment will be allowed to participate.
The recruitment strategy is detailed below:
HUHS/CAMHS:
Students visiting the HUHS website or the CAMHS website will be able to view information about the study and a link which will direct them to the iWellness Study website in order to enroll.
Students who seek care at HUHS CAMHS for symptoms of depression and anxiety will be offered the option to participate in the study when registering for an initial assessment at HUHS CAMHS. Students will be directed to the study website to view information about the study and a link to complete an enrollment eligibility survey.
Other recruitment efforts:
* Harvard graduate students who have completed a mental wellness survey as part of the Graduate Student Mental Health Initiative led by Dr. Paul Barreira would be invited to participate in this study after completing the survey by clicking on the link to enroll. The graduate wellness survey is accessible and distributed to graduate students in departments who agree to participate.
* Students will be able to obtain information about the study through campus outreach efforts for mental health promotion including the college and graduate/professional schools.
* Students will also be able to obtain information through relevant campus organizations and campus resource centers. Students would be directed to study information on the HUHS website.
Sample size: By targeting a broader population for recruitment our goal will be to recruit approximately 250-300 students in the study over approximately a 3-month enrollment period.
This is estimated based on data from our recruitment sources including students making new appointments at HUHS CAMHS, visiting the HUHS website, and Harvard graduate students who complete a mental health screening who would all be invited to participate in the study.
This sample size would allow us to obtain 0.80 power to detect significant improvement (Cohen d = 0.4) and significance 0.05.
Baseline Assessment and Group Assignment
Once a participant is recruited, they will go through the same enrollment process as in the pilot study in which they will be directed to the study enrollment website where interested participants will complete a survey to determine eligibility including information about basic demographics and mobile device ownership. Those meeting basic eligibility requirements will also complete screening using the Patient Health Questionnaire - 9 (PHQ-9) and the Generalized Anxiety Disorder 7-item scale (GAD-7) to determine final eligibility. If eligible, participants will agree to participate via an electronic consent form.
In order to test the possible mediator of change, participants will also be asked to fill out a baseline assessment of perceived stress using the Perceived Stress Scale and isolation using the Hughes Loneliness Scale.
Participants will then be randomly assigned to either the Wysa intervention app or the Harvard College Mobile app and given instructions on how to download their assigned app. Participants from both groups will continue to use their assigned app for 8 weeks after enrollment. Participants will receive a secure Qualtrics survey via email at 2-weeks, 4-weeks and 8-weeks. The endpoint of the study will be 8-weeks after enrollment. At the 8-week endpoint, participants will again receive a secure survey including the PHQ-9, GAD-7, Perceived Stress Scale, and the Hughes Loneliness Scale and questions about their satisfaction with the app and their overall care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active Comparator: App 1 Study group (Wysa)
Wysa App
Wysa provides free, 24/7, emotional support to users through an app-based AI chatbot system. All Wysa chats are anonymous. The AI-based bot responds to the users' emotions and uses CBT, DBT, meditation, breathing, yoga, motivational interviewing, and micro-actions to help the user manage their emotions and encourage mental well-being. In addition, there are over a hundred AI-guided self-care exercises which are backed by science and handpicked by therapists.
Wysa
Participants in the intervention arm will be able to log into the Wysa app at any time of day. They can chat with the AI-based bot, Wysa, or choose to complete different self-care exercises. These exercises are grouped into tool packs, which include dealing with relationships, overcoming loneliness, managing mood, among many others. Users can engage in simple, therapeutic exercises including mindfulness and cognitive re-structuring for negative thinking.
Placebo Comparator: App 2 Study Group (Harvard College Mobile)
Harvard College Mobile App
"Harvard College Mobile" is an informational app developed by the Harvard University, and is designed to help students navigate resources on campus including professional and peer support groups, but does not allow direct messaging through the app. All Harvard students have full access to the contents of this application.
Harvard College App
Participants in the control arm will be given instructions on how to download and utilize the Harvard College App. Students assigned to this app receive instructions on how to utilize the app to navigate resources on campus to support their mental health including professional and peer support groups and how to make an appointment at the Counseling and Mental Health Services. Participants cannot send messages or share any information through the app.
Interventions
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Wysa
Participants in the intervention arm will be able to log into the Wysa app at any time of day. They can chat with the AI-based bot, Wysa, or choose to complete different self-care exercises. These exercises are grouped into tool packs, which include dealing with relationships, overcoming loneliness, managing mood, among many others. Users can engage in simple, therapeutic exercises including mindfulness and cognitive re-structuring for negative thinking.
Harvard College App
Participants in the control arm will be given instructions on how to download and utilize the Harvard College App. Students assigned to this app receive instructions on how to utilize the app to navigate resources on campus to support their mental health including professional and peer support groups and how to make an appointment at the Counseling and Mental Health Services. Participants cannot send messages or share any information through the app.
Eligibility Criteria
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Inclusion Criteria
* Own a smartphone with Wi-Fi or 3G/4G capabilities
* Current student at Harvard University
* A PHQ-9 score of 5 or greater (indicating mild symptoms of depression or greater), or a score of 2 or greater on PHQ item 10 (indicating that they felt disabled in their life because of their mood) or a GAD-7 score of 8 or greater (indicating mild symptoms of anxiety or greater) will be required for enrollment.
Exclusion Criteria
* Anyone who indicates thoughts of harm to themselves or others (PHQ-9 item 9 score \> 0) during initial screening will be excluded from participation in the study.
* Participants with a PHQ-9 Q9 suicide item score \> 0 will receive an automated notification that they are not eligible to participate in the study and that they should call the Harvard Counseling and Mental Health Services 24/7 line. Study staff will also inform Chief of HUHS CAMHS to reach out to the participant.
18 Years
ALL
No
Sponsors
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Harvard University
OTHER
Responsible Party
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Leslie Tarver
Principal Investigator
Principal Investigators
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Giang Nguyen, MD
Role: STUDY_DIRECTOR
Harvard University
Locations
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Harvard University Health Services
Cambridge, Massachusetts, United States
Countries
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References
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Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
Anthes E. Mental health: There's an app for that. Nature. 2016 Apr 7;532(7597):20-3. doi: 10.1038/532020a. No abstract available.
Arean PA, Hallgren KA, Jordan JT, Gazzaley A, Atkins DC, Heagerty PJ, Anguera JA. The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. J Med Internet Res. 2016 Dec 20;18(12):e330. doi: 10.2196/jmir.6482.
Center for Collegiate Mental Health (CCMH). 2016 Annual Report. Publication No. STA 17-74. January, 2017.
Center for Collegiate Mental Health (CCMH). 2020 Annual Report. Publication No. STA 21-045. January, 2021.
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Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, Sarris J. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry. 2017 Oct;16(3):287-298. doi: 10.1002/wps.20472.
Grist R, Porter J, Stallard P. Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. J Med Internet Res. 2017 May 25;19(5):e176. doi: 10.2196/jmir.7332.
Montagni I, Tzourio C, Cousin T, Sagara JA, Bada-Alonzi J, Horgan A. Mental Health-Related Digital Use by University Students: A Systematic Review. Telemed J E Health. 2020 Feb;26(2):131-146. doi: 10.1089/tmj.2018.0316. Epub 2019 Mar 19.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Lattie EG, Adkins EC, Winquist N, Stiles-Shields C, Wafford QE, Graham AK. Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review. J Med Internet Res. 2019 Jul 22;21(7):e12869. doi: 10.2196/12869.
Mistler, et al. Association for University and College Counseling Center Directors Annual Survey, 2012.
Mohr DC, Burns MN, Schueller SM, Clarke G, Klinkman M. Behavioral intervention technologies: evidence review and recommendations for future research in mental health. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):332-8. doi: 10.1016/j.genhosppsych.2013.03.008. Epub 2013 May 8.
Pew Research Center. Mobile Fact Sheet. April 7, 2021. < https://www.pewresearch.org/internet/fact-sheet/mobile/>
Qu C, Sas C, Dauden Roquet C, Doherty G. Functionality of Top-Rated Mobile Apps for Depression: Systematic Search and Evaluation. JMIR Ment Health. 2020 Jan 24;7(1):e15321. doi: 10.2196/15321.
Rosenberg, Morris. 1989. Society and the Adolescent Self-Image. Revised edition. Middletown, CT: Wesleyan University Press.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Anderson M. Technology device ownership. Washington, DC: Pew Research Center; 2015.
Other Identifiers
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IRB21-1024
Identifier Type: -
Identifier Source: org_study_id
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