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Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder

NCT00118534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 943

Last updated 2014-05-05

Study results available
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Summary

The primary study objective is to conduct a prospective, randomized controlled clinical trial that compares the effectiveness of two approaches for delivering smoking cessation treatment for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation treatment is integrated into mental health care for PTSD and delivered by mental health providers (experimental condition) will be compared to specialized smoking cessation clinic referral (VA's usual standard of care).

Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC versus USC, (b) identify treatment process variables that explain (mediate) observed differences in smoking abstinence rates for the two study conditions, and (c) determine whether cessation from smoking is associated with worsening of symptoms of PTSD and/or depression.

Conditions

  • Mental Health
  • Stress Disorders, Post-Traumatic
  • Substance-Related Disorders
  • Tobacco Use Disorder

Interventions

BEHAVIORAL

Integrated Care for Smoking Cessation in PTSD patients

Smoking cessation therapy is integrated with PTSD therapy.

BEHAVIORAL

Standard of Care

Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.

Sponsors & Collaborators

Principal Investigators

  • Miles E McFall, PhD · VA Puget Sound Health Care System, Seattle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118534 on ClinicalTrials.gov