Evaluating a Mobile App for Students Seeking Care for Depression and Anxiety at Harvard University Health Services

NCT03552900 | Completed

• 1 other identifier: IRB17-1876
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Background: There is a growing demand for mental health services on college campuses. At the same time there has been a dramatic surge in development of mobile mental health apps. Given the widespread popularity and utilization of mobile apps in the college-age population, there is an opportunity to leverage these tools to improve services. The study aims to evaluate the effects of a mobile app on reducing symptoms of depression and anxiety for students awaiting their first visit at Harvard Counseling and Mental Health Services (CAMHS), and on enhancing recovery after beginning treatment. Methods: Students seeking an appointment at Harvard CAMHS who meet eligibility criteria will be randomized to receive one of two apps: a direct online social support (7cups) or an app that provides information about community, health, wellness, academic, and support resources on campus (Bliss). Participants will complete a baseline assessment using the PHQ-9 and GAD-7 and a measure of perceived social support. They will be asked to use their assigned app while awaiting their intake appointment and during treatment. The primary endpoint will be at 2 weeks after enrollment and the secondary endpoints at 4, 8- and 12 weeks after enrollment. At all endpoints participants will complete a PHQ-9, GAD-7 and a survey assessing their experience with the app. At the 8-week endpoint they will also be asked about their overall satisfaction with their care and their perceived social support. Results: Feasibility and acceptability of the app will be evaluated by analyzing usage metrics of the 7cups app, self-report satisfaction questionnaire as well as trial adherence. Changes in PHQ-9 and GAD-7 scores between the two groups at baseline, primary and secondary endpoints will be analyzed as well as associations between PHQ-9, GAD-7 scores and patient socio-demographic and social support variables. Mediators of change in symptoms including frequency of use, activities used on app and perceived social support will also be analyzed.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire - 9 (PHQ-9)

  The PHQ-9 is a 9-question multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The Patient Health Questionnaire (PHQ-9) Scoring: Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The nine item version of the Patient Health Questionnaire (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 signicant symptoms of depression.

  At two weeks after enrollment, participants will receive an email to complete the PHQ-9 and GAD-7, which will serve as the primary outcome measure of the study.

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

  The GAD-7 is a 7 item instrument for screening and severity measuring of generalized anxiety disorder (GAD). 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.

  At two weeks after enrollment, participants will receive an email to complete the PHQ-9 and GAD-7, which will serve as the primary outcome measure of the study.

Secondary Outcomes (4)

• Multidimensional Scale of Perceived Social Support

  Participants will receive this instrument at baseline, and at the 4 and 8-week endpoint.

• Client Satisfaction Questionnaire (CSQ-8)

  Participants will receive a survey to complete this questionnaire at the 8 week endpoint

• Participant Experience Survey

  Participants will receive a survey to complete this questionnaire at the 2, 4, 8 and 12 week endpoint

• Secondary Process Outcome Survey

  Participants will receive a survey to complete this questionnaire at the 4 and 8 week endpoint

Study Arms (2)

App 1 Study group (7cups)

ACTIVE COMPARATOR

Participants assigned to this group will be assigned a behavioral intervention, the mobile app ("7cups") which allows participants access to direct online social support via the app.

Behavioral: 7cups Mobile App

App 2 Study Group (Bliss

ACTIVE COMPARATOR

Participants assigned to this group will be assigned to a behavioral intervention, the mobile app (" Bliss ") which provides participants an informational app about mental health resources at Harvard.

Behavioral: Bliss

Interventions

7cups Mobile App BEHAVIORAL

Participants who receive the 7 Cups mobile app will get access to direct online social support by messaging with a listener, participating in group chats as well as evidence-based information and exercises to promote their mental health.

App 1 Study group (7cups)

Bliss BEHAVIORAL

Participants who receive the Bliss app will get access to an app that that provides access to important community, health, wellness, academic, and support resources.

App 2 Study Group (Bliss

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 Harvard students, 18 years old or older, own a smartphone with Wi-Fi or 3G/4G capabilities and have a triage appointment scheduled with Harvard Counseling and Mental Health. Those meeting basic eligibility requirements will also complete screening using the Patient Health Questionnaire - 9 and the Generalized Anxiety Disorder 7-item scale to determine final eligibility and obtain baseline assessment. A PHQ-9 score of 5 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 will be required for enrollment.

You may not qualify if:

• \*Participants with a PHQ-9 suicide item score of 1 or more will not be excluded from the study but will receive an automated message with information to call HUHS urgent care if they are feeling at risk of harm to themselves or others. Study staff will also notify CAMHS staff within one business day so that a member of staff can reach out to the participant and check in about scheduling an urgent care appointment.

Sponsors & Collaborators

• Harvard University: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Harvard University Health Services

Cambridge, Massachusetts, 02138, United States

Location

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Leslie Tarver, MD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Paul Barreira, MD

  Harvard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will not be masked to their mobile app however investigators conducting data analysis will be blinded to which participants were assigned to which app
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Researcher

Model Details: Participants will be randomly assigned to one of two study groups and assigned to one of two different mobile apps

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: June 12, 2018
• Study Start: April 16, 2018
• Primary Completion: July 16, 2018
• Study Completion: July 30, 2018
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)