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

NCT ID: NCT00419029

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Depression; Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

control

brief telephone check-in (no motivational interviewing)

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: BEHAVIORAL

brief telephone check-in (no motivational interviewing)

telephone-administered motivational interviewing

motivational interviewing sessions

Group Type: EXPERIMENTAL

telephone-administered motivational interviewing

Intervention Type: BEHAVIORAL

telephone motivational interviewing

Interventions

telephone-administered motivational interviewing

telephone motivational interviewing

Intervention Type: BEHAVIORAL

control

brief telephone check-in (no motivational interviewing)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Karen Seal

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen H Seal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, University of California, San Francisco

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

MH 06-004

Identifier Type: -

Identifier Source: org_study_id