- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00419029
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
Motivational Interviewing to Engage OEF/OIF Veterans in Mental Health Treatment
Study Overview
Status
Intervention / Treatment
Detailed Description
Project Background/Rationale: Recent reports suggest that a substantial proportion of OEF/OIF veterans suffer from one or more co-occurring mental health disorders, particularly post-traumatic stress disorder (PTSD), depression, and substance use disorders. Many newly returning veterans fail to initiate or complete an adequate course of mental health treatment largely owing to barriers that include inherent features of the mental illness, practical and logistical concerns, and stigma. Untreated mental illness threatens to produce functional and occupational disability as occurred with Vietnam-era veterans. Motivational Interviewing (MI) is an evidence-based, client-centered, therapeutic technique shown to enhance mental health treatment engagement in high-risk populations by helping patients explore and resolve barriers to care.
Project Objectives: The aims of this proposal are: (1) to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) compared to telephone-administered informational support sessions (Control) to enhance mental health treatment initiation and retention among OEF/OIF veterans who screen positive for one or more mental health disorders; (2) to compare change in mental health symptoms and quality of life among veterans assigned to TAMI versus Control, and (3) to describe barriers to mental health treatment engagement among OEF/OIF veterans and assess the putative mechanism by which TAMI increases mental health treatment engagement.
Project Methods: The study is a two-arm randomized controlled trial. We will conduct telephone-administered psychometric screening for PTSD, depression, high-risk alcohol and substance use among 1,000 OEF/OIF veterans residing in Northern California. In addition, we will collect baseline data on sociodemographic and military service-related characteristics, VA and non-VA mental health treatment experiences, barriers and motivation to initiate and/or follow-up with VA mental health appointments. Approximately 300 OEF/OIF veterans screening positive for one or more mental health disorders will receive a referral to mental health treatment in their area and will be randomly assigned to either an initial TAMI session followed by two booster TAMI sessions at 1 and 3 months versus three informational support sessions balanced for time and attention. We will measure outcomes at baseline, one, three, and six months. We will test the hypotheses that OEF/OIF veterans receiving TAMI as compared to the Control condition will be more motivated and hence more likely to overcome barriers to initiate and attend follow-up VA mental health treatment appointments and will have greater improvements in mental health symptoms and quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94121
- San Francisco VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Veteran of OEF/OIF with service in Iraq or Afghanistan, or areas surrounding these combat theaters
- Military service separation date after 9/30/01
- Has a zip code that corresponds to a Northern California address and no plans to relocate
- May be contacted by telephone
- Must screen positive for one or more of the following: PTSD, depression, high-risk alcohol and/or illicit substance use to enroll in the randomized controlled trial.
Exclusion criteria:
- Veterans who served post-9/11/01 but who did not serve in Operation Enduring Freedom or Operation Iraqi Freedom
- In VA or non-VA mental health treatment currently
- Residing more than 60 miles from San Francisco VA or a Community-based outpatient clinic associated with San Francisco VA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control
brief telephone check-in (no motivational interviewing)
|
brief telephone check-in (no motivational interviewing)
|
|
Experimental: telephone-administered motivational interviewing
motivational interviewing sessions
|
telephone motivational interviewing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the efficacy of TAMI, the primary outcome is the binary distinction between those who make an initial phone call to the OEF/OIF Combat Case Manager to arrange for a mental health treatment appointment versus those who do not (Aim 1).
Time Frame: measured 6 months post last follow-up appointment
|
measured 6 months post last follow-up appointment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the binary distinction between attending an initial or re-engagement VA mental health treatment appointment versus not
Time Frame: 6 months post last follow-up appointment
|
6 months post last follow-up appointment
|
|
the total number of VA mental health treatment sessions attended
Time Frame: 6 months p ost last follow-up appointment
|
6 months p ost last follow-up appointment
|
|
the proportion of sessions attended per those scheduled during the 6-month follow-up period
Time Frame: 6 months post last follow-up
|
6 months post last follow-up
|
|
change in mental health symptom scores between the TAMI and Control groups
Time Frame: last follow-up appointment
|
last follow-up appointment
|
|
change in quality of life score from baseline at 1, 3, and 6 months.
Time Frame: last follow-up appointment
|
last follow-up appointment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karen H Seal, MD, MPH, San Francisco VA Medical Center, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH 06-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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