iWellness Study: Evaluation of a CBT Chatbot App to Promote Mental Wellness in Students
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harvard University
- Enrollment
- 289
- Locations
- 1
- Primary Endpoint
- Depression - Patient Health Questionnaire - 9 (PHQ-9)
Study Overview
Brief Summary
The study aims to evaluate whether use of a mobile mental health app improves outcomes of depression and anxiety for students.
Detailed Description
There is a mental health crisis on college campuses with a growing demand for mental health services and increasing wait times. At the same time, there has been a dramatic surge in the development of mobile mental health apps. Thus, there is an opportunity to leverage these tools to improve mental health services. Our recent pilot study demonstrated the acceptability of using a mental health app to augment college mental health services and the feasibility of a fully digital approach to recruit and randomize students. The findings serve as a proof of concept for a full trial.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Wysa (Other)
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.
Intervention: Harvard College App (Other)
Outcomes
Primary Outcomes
Depression - Patient Health Questionnaire - 9 (PHQ-9)
Time Frame: 8 weeks
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.
Anxiety - Generalized Anxiety Disorder 7-item scale (GAD-7)
Time Frame: 8 weeks
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.
Secondary Outcomes
- Loneliness - Hughes Loneliness scale(8 weeks)
- Perceived Stress - Perceived Stress Scale (PSS)(8 weeks)
Investigators
Leslie Tarver
Principal Investigator
Harvard Medical School (HMS and HSDM)