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

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ClinicalTrials.gov Identifier: NCT03552900
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Leslie Tarver, Harvard University

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: an app offering direct online social support (7cups) or an app that provides information about mental health 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.


Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: 7 Cups Mobile App Behavioral: Bliss Mobile App Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of two study groups and assigned to one of two different mobile apps
Masking: Single (Investigator)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Evaluating the Use of a Mobile App to Reduce Symptoms of Depression and Anxiety for Students Seeking Care at Harvard University Health Services
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: App 1 Study group (7 Cups)
Participants assigned to this group will be assigned a behavioral intervention, the mobile app ("7 Cups") which allows participants access to direct online social support via the app.
Behavioral: 7 Cups Mobile App
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.

Active Comparator: App 2 Study Group (Bliss)
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 Mobile App
Participants who receive the Bliss mobile app will get access to an app that that provides information and offers a personal approach to navigate through mental health resources on Harvard's campus.




Primary Outcome Measures :
  1. Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: 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. ]

    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.


  2. Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: 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. ]

    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.



Secondary Outcome Measures :
  1. Multidimensional Scale of Perceived Social Support [ Time Frame: Participants will receive this instrument at baseline, and at the 4 and 8-week endpoint. ]

    Instrument to assess participant's perceived social support. Includes 12 questions where participants rate their responses on a scale of 1 to 7 ("1" Very Strongly Disagree, "2" Strongly Disagree, "3" Mildly Disagree, "4" Neutral, "5" Mildly Agree, "6" Strongly Agree "7" Very Strongly Agree).

    The items can be divided into subgroups relating to the source of social support, namely family (Fam), friends (Fri) or significant other (SO).

    Scoring Information: To calculate mean scores:

    Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4. Family Subscale: Sum across items 3, 4, 8, & 11, then divide by 4. Friends Subscale: Sum across items 6, 7, 9, & 12, then divide by 4. Total Scale: Sum across all 12 items, then divide by 12.

    The 12-item MSPSS scale has a mean continuous score ranging from 1-84. Higher scores indicate greater perceived social support.


  2. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Participants will receive a survey to complete this questionnaire at the 8 week endpoint ]

    Questionnaire to assess patient satisfaction with care.

    The CSQ-8 is a brief measure to assess patients' satisfaction the service they received from university health services. CSQ-8 is an 8-item scale with scores that range from 8 to 32, with higher values indicating higher satisfaction.


  3. Participant Experience Survey [ Time Frame: Participants will receive a survey to complete this questionnaire at the 2, 4, 8 and 12 week endpoint ]
    12-item questionnaire to measure participant's qualitative experiences with their assigned mobile app including overall utility, what activities were most used, help achieving goals, etc.

  4. Secondary Process Outcome Survey [ Time Frame: Participants will receive a survey to complete this questionnaire at the 4 and 8 week endpoint ]
    4 items to assess participants' use of other forms of care during the study including urgent mental health care, primary care and seeking help from others



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria: Those who score less than or equal to 5 on PHQ-9 or less than 8 on the GAD-7 during study screening will be excluded from the study and sent an automated message with information to contact HUHS CAMHS if their symptoms worsen and they need to be seen urgently.

*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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552900


Contacts
Contact: Leslie Tarver, MD 617 495-2042 lbtarver@partners.org
Contact: Sheena Wood, BA 617-432-1408 sheeena_wood@hms.harvard.edu

Locations
United States, Massachusetts
Harvard University Health Services Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Paul Barreira, MD    617-495-5711      
Contact: Leslie Tarver, MD    617 495-5711    lbtarver@partners.org   
Sponsors and Collaborators
Harvard University
Harvard Medical School
Investigators
Principal Investigator: Leslie Tarver, MD Harvard University
Study Director: Paul Barreira, MD Harvard University

Publications:
American College Health Assocation. American College Health Association-National College Health Assessment II: Reference Group Executive Summary Spring 2013. Linthicum, MD: American College Health Association; 2013.
Anderson M. Technology device ownership. Washington, DC: Pew Research Center; 2015.
Center for Collegiate Mental Health (CCMH). 2015 Annual Report. Publication No. STA 15-108. January 2016. https://sites.psu.edu/ccmh/files/2017/10/2015_CCMH_Report_1-18-2015-yq3vik.pdf
Center for Collegiate Mental Health (CCMH). 2016 Annual Report. Publication No. STA 17-74. January, 2017. <https://sites.psu.edu/ccmh/files/2017/01/2016-Annual-Report-FINAL_2016_01_09-1gc2hj6.pdf>
Gruttadaro, D and Crudo D., National Alliance on Mental Illness: College Students Speak: A Survey Report on Mental Health. 2012.
Mistler, B., et. al. Association for University and College Counseling Center Directors Annual Survey, 2012.

Responsible Party: Leslie Tarver, Physician Researcher, Harvard University
ClinicalTrials.gov Identifier: NCT03552900     History of Changes
Other Study ID Numbers: IRB17-1876
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders