iWellness Study to Evaluate a Mental Health App for Students

NCT05234970 | Completed DMC

• 1 other identifier: IRB21-1024
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate whether use of a mobile mental health app improves outcomes of depression and anxiety for students.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Depression - Patient Health Questionnaire - 9 (PHQ-9)

  PHQ-9: A 9-question multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scoring: Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The nine item version of the PHQ-9 was designed to facilitate the recognition and diagnosis of depression in primary care patients. It can be used to monitor change in symptoms over time and provides a depression severity index score as follows: 0-4 None 5-9 Mild 10 - 14 Moderate 15 - 19 Moderately Severe 20 - 27 Severe The recommended cut-off for the PHQ-9 severity index is a score of 9. Anyone who scores 10 or above can be considered to be suffering from clinically significant symptoms of depression.

  8 weeks

• Anxiety - Generalized Anxiety Disorder 7-item scale (GAD-7)

  GAD-7: A diagnostic self-report 7-item scale for screening, diagnosis, and severity assessment of generalized anxiety disorder. Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The index scores are as follows: 0-4 None 5-10 Mild Anxiety 11 - 15 Moderate Anxiety 15 - 21 Severe Anxiety The recommended cut off for the GAD-7 severity index is a score of 7. Anyone who scores 8 or above can be considered to be suffering from clinically significant anxiety symptoms.

  8 weeks

Secondary Outcomes (2)

• Perceived Stress - Perceived Stress Scale (PSS)

  8 weeks

• Loneliness - Hughes Loneliness scale

  8 weeks

Study Arms (2)

Active Comparator: App 1 Study group (Wysa)

ACTIVE COMPARATOR

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.

Other: Wysa

Placebo Comparator: App 2 Study Group (Harvard College Mobile)

PLACEBO COMPARATOR

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.

Other: Harvard College App

Interventions

Wysa OTHER

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.

Active Comparator: App 1 Study group (Wysa)

Harvard College App OTHER

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.

Placebo Comparator: App 2 Study Group (Harvard College Mobile)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be required to be at 18 years or older
• 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.

You may not qualify if:

• Those who score less than 5 on PHQ-9 or less than 8 on the GAD-7 during study screening will be excluded from the study.
• 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.

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University Health Services

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (19)

• Aboujaoude E, Salame W, Naim L. Telemental health: A status update. World Psychiatry. 2015 Jun;14(2):223-30. doi: 10.1002/wps.20218.

  PMID: 26043340 BACKGROUND

• 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.

  PMID: 20967242 BACKGROUND

• 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.

  PMID: 27078548 BACKGROUND

• 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.

  PMID: 27998876 BACKGROUND

• Center for Collegiate Mental Health (CCMH). 2016 Annual Report. Publication No. STA 17-74. January, 2017.

  BACKGROUND

• Center for Collegiate Mental Health (CCMH). 2020 Annual Report. Publication No. STA 21-045. January, 2021.

  BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 28941113 BACKGROUND

• 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.

  PMID: 28546138 BACKGROUND

• 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.

  PMID: 30888256 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 31333198 BACKGROUND

• Mistler, et al. Association for University and College Counseling Center Directors Annual Survey, 2012.

  BACKGROUND

• 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.

  PMID: 23664503 BACKGROUND

• Pew Research Center. Mobile Fact Sheet. April 7, 2021. < https://www.pewresearch.org/internet/fact-sheet/mobile/>

  BACKGROUND

• 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.

  PMID: 32012079 BACKGROUND

• Rosenberg, Morris. 1989. Society and the Adolescent Self-Image. Revised edition. Middletown, CT: Wesleyan University Press.

  BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• Anderson M. Technology device ownership. Washington, DC: Pew Research Center; 2015.

  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Giang Nguyen, MD

  Harvard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be randomly assigned to one of two apps and will be blinded to which is the intervention app and which is the control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 10, 2022
• Study Start: February 24, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)