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Electronic Bridge to Mental Health for College Students (eBridge)

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ClinicalTrials.gov Identifier: NCT03380117
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Cheryl A. King, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Suicide Depression Behavioral: eBridge Online Counseling Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In eBridge, students take an online screen and receive personalized feedback about their self-reported depression, alcohol/substance use, and level of functioning. Students are randomly assigned to either the eBridge or control condition. In the eBridge condition, personalized feedback is provided in a graphic format that is accompanied by motivational-interviewing-adherent statements. In this condition, students' communications with eBridge counselors will occur via online dialogues, in which students and counselors exchange messages using a secure website. In the control condition, personalized feedback will also be delivered online to students, highlighting 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Electronic Bridge to Mental Health for College Students (eBridge)
Actual Study Start Date : November 11, 2014
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eBridge Online Counseling
In the eBridge condition, personalized feedback is provided in a graphic format that is accompanied by motivational-interviewing-adherent statements. In this condition, students have the opportunity to engage with eBridge counselors via online dialogues, in which students and counselors exchange messages using a secure website.
Behavioral: eBridge Online Counseling
In eBridge, students take an online screen and receive personalized feedback about their self-reported depression, alcohol/substance use, and level of functioning. Students are randomly assigned to either the eBridge or control condition. In the eBridge condition, personalized feedback is provided in a graphic format that is accompanied by motivational-interviewing-adherent statements. In this condition, students' communications with eBridge counselors will occur via online dialogues, in which students and counselors exchange messages using a secure website. In the control condition, personalized feedback will also be delivered online to students, highlighting 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.

No Intervention: Control
In the control condition, personalized feedback will also be delivered online to students, highlighting 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.



Primary Outcome Measures :
  1. Change in mental health service utilization [ Time Frame: Baseline, 4 weeks, 6 months ]
    Change in the number of participants accessing mental health services include psychotherapy, psychopharmacological treatment, or a combination.

  2. Adherence to mental health services, as measured by yes/no response for 4-week period. [ Time Frame: 4 weeks ]
    Mental health services include psychotherapy, psychopharmacological treatment, or a combination.

  3. Adherence to mental health services, as measured by total # of sessions for 4-week period. [ Time Frame: 4 weeks ]
    Mental health services include psychotherapy, psychopharmacological treatment, or a combination.

  4. Adherence to mental health services, as measured by yes/no response for 6-month period. [ Time Frame: 6 months ]
    Mental health services include psychotherapy, psychopharmacological treatment, or a combination.

  5. Adherence to mental health services, as measured by total # of sessions for 6-month period. [ Time Frame: 6 months ]
    Mental health services include psychotherapy, psychopharmacological treatment, or a combination.


Secondary Outcome Measures :
  1. Change in suicidal thoughts [ Time Frame: Baseline, 4 weeks, 6 months ]
    Assessed using one item from the National Comorbidity Survey asking about serious suicidal thoughts at Baseline, 4-week, and 6-month intervals. "Have you ever felt so low you thought about committing suicide?" (Yes/No)

  2. Change in suicidal thoughts [ Time Frame: Baseline, 4 weeks, 6 months ]
    Assessed using one item from the National Comorbidity Survey asking about serious suicidal thoughts at Baseline, 4-week, and 6-month intervals. "Has there ever been a period of 2 weeks or more when you felt like you wanted to die?" (Yes/No).

  3. Change in suicide attempts [ Time Frame: Baseline, 4 weeks, 6 months ]
    Two items from the National Comorbidity Survey assess number of suicide attempts at Baseline, 4-week, and 6-month intervals. At Baseline, "How many times have you attempted suicide in your lifetime?" (open-text). At 4-week, and 6-month intervals, "In the past month, have you ever attempted suicide" (Yes/No)

  4. Change in depression, as measured using the Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 4 weeks, 6 months ]
    The PHQ-9 is a 9-item scale based on Diagnostic Statistical Manual IV criteria for a major depressive episode. The instrument asks the respondent to indicate the frequency of various symptoms over the past two weeks and, following standard interpretation algorithms, categorizes participants as screening positive for major depression or not.

  5. Change in substance misuse [ Time Frame: Baseline, 6 months ]
    Substance misuse will be assessed using five questions about recent drug use activity, using a list of commonly abused prescription drugs and illegal. The scale response options include never, once or twice, monthly, weekly, daily, or almost daily.

  6. Change in alcohol misuse [ Time Frame: Baseline, 4 weeks, 6 months ]
    Alcohol misuse will be assessed using the 10-item AUDIT, which asks about frequency of any drinking, average amount per day, and frequency of binge drinking (6 or more drinks on one occasion). It is scored on a 0-12 scale, and a screen cutoff score of 8 is considered optimal to identify students at higher risk.


Other Outcome Measures:
  1. Academic performance, as measured by grade point average [ Time Frame: 6 months ]
    Academic performance will be measured by grade point average at 6 months

  2. Academic performance, as measured by retention [ Time Frame: 6 months ]
    Academic performance will be measured by whether or not the participant is still enrolled in the university.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • at least 18 years old
  • currently enrolled full- or part-time at a participating university

Exclusion Criteria:

  • not currently living in the university community (e.g., completing a study abroad semester)

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): NCT03380117


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Nevada
University of Nevada-Reno
Reno, Nevada, United States, 89557
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Cheryl King, Ph.D. Professor

Responsible Party: Cheryl A. King, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03380117     History of Changes
Other Study ID Numbers: R01MH103244 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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

Keywords provided by Cheryl A. King, University of Michigan:
Suicidal Ideation
Suicide Attempt
Risk Screening
Online Intervention
Online Counseling
College Students
Motivational Interviewing
Linkage to Care

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms