Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
Primary Purpose
Combat Disorders, Stress Disorders, Post-Traumatic, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telephone-administered motivational interviewing
control
Sponsored by
About this trial
This is an interventional screening trial for Combat Disorders focused on measuring combat, depression, PTSD, substance abuse
Eligibility Criteria
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
Sites / Locations
- San Francisco VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
telephone-administered motivational interviewing
Arm Description
brief telephone check-in (no motivational interviewing)
motivational interviewing sessions
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
the binary distinction between attending an initial or re-engagement VA mental health treatment appointment versus not
the total number of VA mental health treatment sessions attended
the proportion of sessions attended per those scheduled during the 6-month follow-up period
change in mental health symptom scores between the TAMI and Control groups
change in quality of life score from baseline at 1, 3, and 6 months.
Full Information
NCT ID
NCT00419029
First Posted
January 4, 2007
Last Updated
August 25, 2014
Sponsor
San Francisco Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00419029
Brief Title
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
Official Title
Motivational Interviewing to Engage OEF/OIF Veterans in Mental Health Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Veterans Affairs Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this randomized controlled trial is to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) to enhance VA mental health treatment engagement among veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) who screen positive for mental health disorders on telephone assessment. The investigators will evaluate whether TAMI results in improved mental health treatment engagement, decreased mental health symptoms and increased quality of life among OEF/OIF veterans with mental health disorders. The long-term aim of this study is to conduct rapid assessment and intervention to prevent chronic mental illness and associated disability among our newest generation of veterans.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combat Disorders, Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
Keywords
combat, depression, PTSD, substance abuse
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
brief telephone check-in (no motivational interviewing)
Arm Title
telephone-administered motivational interviewing
Arm Type
Experimental
Arm Description
motivational interviewing sessions
Intervention Type
Behavioral
Intervention Name(s)
telephone-administered motivational interviewing
Intervention Description
telephone motivational interviewing
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
brief telephone check-in (no motivational interviewing)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
the total number of VA mental health treatment sessions attended
Time Frame
6 months p ost last follow-up appointment
Title
the proportion of sessions attended per those scheduled during the 6-month follow-up period
Time Frame
6 months post last follow-up
Title
change in mental health symptom scores between the TAMI and Control groups
Time Frame
last follow-up appointment
Title
change in quality of life score from baseline at 1, 3, and 6 months.
Time Frame
last follow-up appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen H Seal, MD, MPH
Organizational Affiliation
San Francisco VA Medical Center, University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
We'll reach out to this number within 24 hrs