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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Seal, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier:
NCT00419029
First received: January 4, 2007
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Combat Disorders
Stress Disorders, Post-Traumatic
Depression
Substance-Related Disorders
Behavioral: telephone-administered motivational interviewing
Behavioral: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Motivational Interviewing to Engage OEF/OIF Veterans in Mental Health Treatment

Resource links provided by NLM:


Further study details as provided by San Francisco Veterans Administration Medical Center:

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). [ Time Frame: measured 6 months post last follow-up appointment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • the total number of VA mental health treatment sessions attended [ Time Frame: 6 months p ost last follow-up appointment ] [ Designated as safety issue: No ]
  • the proportion of sessions attended per those scheduled during the 6-month follow-up period [ Time Frame: 6 months post last follow-up ] [ Designated as safety issue: No ]
  • change in mental health symptom scores between the TAMI and Control groups [ Time Frame: last follow-up appointment ] [ Designated as safety issue: No ]
  • change in quality of life score from baseline at 1, 3, and 6 months. [ Time Frame: last follow-up appointment ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2007
Study Completion Date: September 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control
brief telephone check-in (no motivational interviewing)
Behavioral: control
brief telephone check-in (no motivational interviewing)
Experimental: telephone-administered motivational interviewing
motivational interviewing sessions
Behavioral: telephone-administered motivational interviewing
telephone motivational interviewing

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419029

Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
San Francisco Veterans Administration Medical Center
Investigators
Principal Investigator: Karen H Seal, MD, MPH San Francisco VA Medical Center, University of California, San Francisco
  More Information

No publications provided

Responsible Party: Karen Seal, Principle Investigator, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier: NCT00419029     History of Changes
Other Study ID Numbers: MH 06-004
Study First Received: January 4, 2007
Last Updated: August 25, 2014
Health Authority: United States: Federal Government

Keywords provided by San Francisco Veterans Administration Medical Center:
combat
depression
PTSD
substance abuse

Additional relevant MeSH terms:
Combat Disorders
Depression
Depressive Disorder
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014