CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 943 enrolled
Drug / intervention
Integrated Care for Smoking Cessation in PTSD patients +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • Diagnosis of PTSD from military trauma per DSM-IV criteria
  • Current heavy smoking: ≥10 cigarettes per day for ≥16 of past 30 days before randomization
  • Demonstrated motivation to quit smoking
  • Minimum 4 mental health treatment sessions from SOPP spanning ≥1 month interval
Key exclusion· 7
  • Use of smokeless tobacco, pipes, or cigars
  • Active psychotic disorder (not in remission)
  • Active bipolar disorder (not in remission)
  • Active substance dependence disorder (unless in remission >1 month)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00118534
NCT00118534N/ACompleted

CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)

US Department of Veterans Affairs·interventional·Posted Jul 11, 2005·Updated May 5, 2014

In Brief

A clinical study evaluating Integrated Care for Smoking Cessation in PTSD patients and Standard of Care for Mental Health and 3 related conditions. Completed, enrolled 943 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2005
Enrollment StartJul 1, 2004
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.0 years ago

Interventions

Integrated Care for Smoking Cessation in PTSD patientsbehavioral

Smoking cessation therapy is integrated with PTSD therapy.

Standard of Carebehavioral

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