Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment

August 25, 2014 updated by: Karen Seal, San Francisco Veterans Affairs Medical Center

Motivational Interviewing to Engage OEF/OIF Veterans in Mental Health Treatment

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.

Study Overview

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

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen H Seal, MD, MPH, San Francisco VA Medical Center, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

August 26, 2014

Last Update Submitted That Met QC Criteria

August 25, 2014

Last Verified

August 1, 2014

More Information

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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