Depression Clinical Trial
Official title:
Electronic Bridge to Mental Health for College Students (eBridge)
Electronic Bridge to Mental Health for College Students (eBridge) is an online intervention that screens students for mental health concerns that include elevated suicide risk and facilitates their linkage to mental health (MH) services. EBridge is designed to work on computers, tablets, and smartphones (iOS, Android) and is easily adaptable to evolving technologies in the future. It incorporates motivational interviewing (MI) principles and draws from health behavior models that emphasize autonomy and self-determination. Following a web-based screen using standardized scales to identify students at elevated risk, eBridge offers students options for personalized feedback (provided online in a conversational format adherent with motivational interviewing) and corresponding online with professionals trained in motivational interviewing and knowledgeable about university and community resources. Ebridge is being conducted at four universities: the University of Michigan, the University of Nevada-Reno, the University of Iowa, and Stanford University.
This randomized controlled trial will examine the efficacy of the intervention, Electronic
Bridge to Mental Health for College Students (eBridge), in a large-scale, multi-university
trial involving students at the University of Michigan, the University of Iowa, the
University of Nevada-Reno, and Stanford University. Subject recruitment will take place in
the fall academic semester during each year of data collection. All 6-month follow-up
assessments will occur 5 to 6 months later and before many students leave campus for a spring
or summer break. The study team will send recruitment emails between late September and
October, and five to six-month follow-up emails in March or April. Student email addresses
will be obtained from the registrar database of each participating university, per the
standard Institutional Review Board and administrative process for obtaining such directory
information for research studies. Furthermore, this process uses methods to maximize the
security and confidentiality of the students' data, such as giving them unique identifiers to
log into the web site (rather than identifiers that contain their name or email address) and
using state-of-the-art security software to protect the website from having information
intercepted. The planned number of student names and email addresses for possible
participation will be randomly drawn. The study team will then send emails inviting students
into the study, with up to 3 reminders spaced by 3-4 days for those who have yet to respond.
The emails will note that students can reply and decline participation (and any further
reminders). For those interested in participating, the email will contain a link to a secure
web site where they can view the informed consent and decide whether to participate. The
eBridge invitation email, screening, and all subsequent contacts via the Internet are
confidential.
Personalized Feedback (PF) will be delivered online and provide feedback to students about
their self-reported depression, alcohol/substance use, and level of functioning. This report
is a briefer, modified version of the Personalized Feedback Report used in COMBINE, the
multi-site clinical trial conducted to study the efficacy of treatments for alcohol
dependence. The report highlights personal data and specifies links between our key screening
variables and risk of negative outcomes. In the eBridge condition, PF is provided in a
graphic format that is accompanied by MI-adherent statements. In addition, students in the
eBridge condition have the option of viewing or not viewing their PF, and of choosing to
observe their PF in one or more domain.
Students' communications with eBridge counselors (MI-trained mental health professionals)
will occur via online dialogues, in which students and counselors exchange messages using a
secure web site. The total duration of the exchanges is expected to be brief, in keeping with
MI approaches used in medical settings to consider behavior change and/or treatment
recommendations and as found in our R34 study. Students will be able to communicate with
eBridge counselors using asynchronized communication (with email notification that response
has been posted on secure website) at any time.
Personalized Feedback (PF) will also be delivered online to students in the control
condition, providing information to students about their self-reported depression,
alcohol/substance use, and level of functioning. As for students in the eBridge condition, it
will highlight their personal data and specify links between key screening variables and
negative outcomes. However, in the control condition, this is provided in a straightforward
graphic, informational format, which is consistent with standard practice in online screening
programs for college students (e.g., www.ulifeline.org). All students in the control
condition receive their PF immediately upon completing their screening survey (automatic next
screen).
Each student, regardless of study condition, will see a list of campus and community
resources for mental health and alcohol/substance abuse treatment, and for crisis services.
These will be presented on each webpage of both the screening survey and the PF report. The
resource information list has been uploaded to this application as an additional document.
The research team will collect quantitative and qualitative data. Quantitative data will be
collected from subjects using brief questionnaires at baseline, 4 weeks, and six months. A
subset of questions from the baseline questionnaire will serve as the screen that determines
whether subjects are eligible for randomization. The baseline questionnaire will be
programmed such that, once determined that a subject does not meet criteria for
randomization, he or she will not be asked any more questions. The measures will be brief,
requiring approximately 2-10 minutes for completion (5-6 minutes at 4-weeks), because brevity
is a determinant of response rates for Internet surveys.
Students will be assessed at 4 weeks because a subset may derive benefit from the online
intervention itself. This assessment occurs following exposure to eBridge, yet before
participants are likely to have started using services. This will help to ascertain whether
some reduction in risk factors is due to the web-based intervention itself rather than to
linkage to services. This brief assessment will consist of the three suicidal
ideation/behavior items, the Patient Health Questionnaire-9 (PHQ-9), the PHQ-10 (single
item), the Alcohol Use Disorders Identification Test (AUDIT), mental health service
utilization items, and the readiness scale (see below). A full outcome assessment will be
conducted at 6 months.
Participants will be remunerated for involvement in the study. A random drawing will take
place for all who have received an invitation to participate. In addition a 4-week
pre-incentive will be distributed to encourage students to participate. Finally, 4-week and
6-month incentives will be distributed upon completion of each assessment.
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