NCT00419029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

3 years

First QC Date

January 4, 2007

Last Update Submit

August 25, 2014

Conditions

Keywords

combatdepressionPTSDsubstance abuse

Outcome Measures

Primary Outcomes (1)

  • 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).

    measured 6 months post last follow-up appointment

Secondary Outcomes (5)

  • the binary distinction between attending an initial or re-engagement VA mental health treatment appointment versus not

    6 months post last follow-up appointment

  • the total number of VA mental health treatment sessions attended

    6 months p ost last follow-up appointment

  • the proportion of sessions attended per those scheduled during the 6-month follow-up period

    6 months post last follow-up

  • change in mental health symptom scores between the TAMI and Control groups

    last follow-up appointment

  • change in quality of life score from baseline at 1, 3, and 6 months.

    last follow-up appointment

Study Arms (2)

control

ACTIVE COMPARATOR

brief telephone check-in (no motivational interviewing)

Behavioral: control

telephone-administered motivational interviewing

EXPERIMENTAL

motivational interviewing sessions

Behavioral: telephone-administered motivational interviewing

Interventions

telephone motivational interviewing

telephone-administered motivational interviewing
controlBEHAVIORAL

brief telephone check-in (no motivational interviewing)

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-TraumaticDepressionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorChemically-Induced Disorders

Study Officials

  • Karen H Seal, MD, MPH

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 5, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations