Expired Study
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Cambridge, Massachusetts 02138


Purpose:

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.


Study summary:

Abstract: 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 apps for mental health. 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 mental health app on reducing symptoms of depression and anxiety for students awaiting their first visit at Harvard Counseling and Mental Health Services (CAMHS), and Harvard graduate students who have been recommended to seek treatment at CAMHS. The feasibility and acceptability of a mobile app intervention with this population will also be assessed, as well as the ways through which the mobile app may contribute to improvement in depression and anxiety among students such as change in perceived social support for students using a mobile social support app. Specific Aims: 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 worst, fatal outcome of suicide leading to devastating consequences for college communities. 64% of young adults who are no longer in college are not attending college because of a mental health related condition and the frequency that students in treatment report having "seriously considered suicide" has increased by almost 40% in the last five years. Despite these facts, still only 25% of students with a mental health concern seek treatment. Technological innovations such as mobile apps hold promise to improve access to care, de-stigmatize treatment and potentially alleviate demand on over-burdened service centers. However, there is limited evidence on the effectiveness and feasibility of use of these mobile platforms. Consequently, there is a pressing need to develop better research modalities for evaluating mobile apps and to elucidate the specific features that are effective at reducing symptoms and are acceptable in this population in order to improve care and inform novel treatment approaches. In this study, participants seeking mental health services at a university health center will receive a mobile social support app. The investigators hypothesize that receiving immediate access to a mobile, anonymous social support app while waiting for an appointment and during treatment will be feasible and acceptable to young adults seeking mental health services, and will yield promising results for improving outcomes of depression and anxiety in comparison to those in the control group. The pilot deign will address the following aims: Aim1: Assess the feasibility and acceptability of providing students access to a mobile social support app to augment available mental health services within a university health center. Aim 2: Evaluate the potential effectiveness of a mobile social support app at reducing symptoms of depression and anxiety for students seeking mental health services. Aim 3: Test the feasibility of conducting a fully remote, digital trial with college students seeking mental health services with randomization to a mobile social support app. Background and Significance: There is a mental health crisis on college campuses across the country. 64% of young adults who are no longer in college are not attending college because of a mental health related condition and the frequency that students in treatment report having "seriously considered suicide" has increased by almost 40% in the last five years. The demand for counseling services has also grown at least five times faster than average student enrollment. This has led to a significant shortage of mental health services for students. Considering the ubiquity of mobile phone usage, particularly in this population -over 86% of young adults aged 18-29 owns a smart phone—there is significant interest in the use of mobile phone apps as a powerful alternate care delivery platform. Additionally, the number of mobile mental health apps is exponentially growing with currently thousands of mental health apps available for download on the Apple or Google Marketplaces. Given their widespread use, 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. There are numerous potential advantages of mobile health applications, such as continuous availability and immediate support, anonymity, customizable content and self-guided treatment approaches. Additionally, these approaches hold promise for increasing access to care particularly for those in remote areas and traditionally hard-to-reach groups. 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, despite the growing number of apps available and the consensus that these innovations hold promise for expanding mental health care delivery, the evidence base for their efficacy remains unclear and research is significantly lagging behind app development. A review of mHealth apps for the most prevalent conditions identified by the WHO identified more than 1536 apps for depression, but only 32 associated published articles. Many mobile platforms developed by commercial companies are widely utilized but have not been adequately evaluated to determine their effectiveness. In a scoping review of the literature on mobile apps for mental health in adolescents, only two RCTs were identified and both failed to demonstrate a significant effect on intended outcomes. A large meta-analysis conducted recently on smartphone interventions for depressive symptoms in adults found a moderate positive effect on depressive symptoms, however, the subgroup analyses found that the effects of smart- phone interventions were substantially larger when compared to inactive (g= 0.56) than active (g=0.22) control conditions. Further, there is a broad spectrum of features ranging from entirely self-guided tools, mixed approaches that combine self-guided tools with interactions with coaches or fully structured programs with an therapist or coach guiding treatment. There is a lack of evidence, however, about which features are most helpful and which approach is best suited for an individual or given population. The evidence on self-guided alone versus provider-supported internet based treatments does indicate that human support significant improves engagement. Initial study findings and high drop out rates also suggests that a major challenge with mobile apps is user attrition and decreased engagement over time. This is where human connection and social support features may play a critical role in maintaining interest and engagement. This pilot study aims to contribute to the understanding of the use of mobile mental health apps targeting a college-age population. By selecting a mainly social support app, it also aims to explore to what degree enhanced social support plays a role in improved outcomes. Research Design: This is a pilot study evaluating the acceptability and outcomes of a mobile social support app, 7 cups which is commercially available and widely utilized by the target population, to reduce symptoms of depression and anxiety for college students seeking mental health services and selected graduate students who have completed a mental health screening and are recommended to seek treatment at CAMHS.. Methods Recruitment and Screening: When students make an initial consultation appointment online for counseling and mental health services (CAMHS), they will be able to click a link about the study which directs them to the study enrollment website. 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 and the Generalized Anxiety Disorder 7-item scale to determine final eligibility. If deemed to be eligible, participants will sign an electronic consent form. Harvard graduate students who have completed a mental wellness survey as part of another research study led by Dr. Bareira, would be invited to participate in this study after completing the survey. For these graduate students, after they complete the survey, if their score indicates mild symptoms of depression or anxiety or greater they would be offered to participate in the mobile app study. It is currently standard practice for graduate students completing the mental wellness surveys that recommendations to seek care at HUHS CAMHS are given If they score with symptoms of depression or anxiety. With the addition of this study, students would now also be invited to participate in the mobile app study as an additional tool to manage their mental and emotional health. Approximately 500 students present to CAMHS seeking services each month depending on the time of year. We have learned from the pilot study that we are likely to enroll approximately 30% of these students with approximately 30% drop out rate. Additionally, there are approximately 300 Harvard graduate students who have completed a mental health screening and would be invited to participate in the study. Again assuming approximately 30-40% of those students enroll in the study and a 30% drop out rate. Thus we anticipate obtaining usable data from approximately 150 participants. This sample size would allow us to obtain 0.80 power to detect significant improvement (Cohen d = 0.4) assuming significance 0.05. Baseline Assessment and Group Assignment: Once enrolled, participants will be asked additional questions to provide baseline assessment such as brief additional demographic information which will include participants' class year, race/ethnicity, use of other mental health apps, and current engagement in mental health treatment. We will ask participants for an email address and phone number for study staff to be able to contact them during the study. In addition, participants will be asked about current use of substances or alcohol as this is known to affect treatment outcomes. This will be collected using the AUDIT-C, a 3-item alcohol screen, which is a modified version of the 10-question AUDIT instrument. Participants will also be asked to complete a brief set of questions about perceived social support to obtain a baseline assessment using the Multidimensional Scale of Perceived Social Support. Participants will then be randomly assigned to 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). Following this, participants are guided through the process of downloading their assigned app on their smartphone, given instructions on how to reach HUHS urgent care if their symptoms worsen and how to contact the study staff with questions.


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 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.


Study is Available At:


Original ID:

IRB17-1876


NCT ID:

NCT03552900


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Harvard University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

250


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Leslie Tarver, MD
Principal Investigator
Harvard University
Primary Contact:Leslie Tarver, MD
617 495-2042
lbtarver@partners.org
Backup Contact:Sheena Wood, BA
617-432-1408
sheeena_wood@hms.harvard.edu

Study Dates

Start Date:October 15, 2019
Completion Date:December 31, 2020
Completion Type:Anticipated
Primary Completion Date:July 31, 2020
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 11, 2019
First Received Date:March 27, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Secondary Process Outcome Survey
Time Frame:Participants will receive a survey to complete this questionnaire at the 4 and 8 week endpoint
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Participant Experience Survey
Time Frame:Participants will receive a survey to complete this questionnaire at the 2, 4, 8 and 12 week endpoin
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Client Satisfaction Questionnaire (CSQ-8)
Time Frame:Participants will receive a survey to complete this questionnaire at the 8 week endpoint
Safety Issues:False
Description: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 val
Outcome Type:Secondary Outcome
Measure:Multidimensional Scale of Perceived Social Support
Time Frame:Participants will receive this instrument at baseline, and at the 4 and 8-week endpoint.
Safety Issues:False
Description: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" Str
Outcome Type:Primary Outcome
Measure: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, w
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure: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, w
Safety Issues:False
Description: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 n

Study Interventions

Intervention Type:Behavioral
Name:7 Cups Mobile App
Description: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.
Arm Name:App 1 Study group (7 Cups)
Intervention Type:Behavioral
Name:Bliss Mobile App
Description: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.
Arm Name:App 2 Study Group (Bliss)

Study Arms

Study Arm Type:Active Comparator
Arm Name:App 2 Study Group (Bliss)
Description: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.
Study Arm Type:Active Comparator
Arm Name:App 1 Study group (7 Cups)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Harvard University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Harvard Medical School

Sample and Retention Information

There are no available Sample and Retention Information

Study References

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PMID:28546138
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PMID:28941113
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PMID:28110672
Reference Type:Reference
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Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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