N/A
Completed N=943
Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
Mental Health Disorders · Stress Disorders, Post-Traumatic · Substance-Related Disorders · Tobacco Use
Source: ClinicalTrials.gov NCT00118534 ↗
Enrolled (actual)
943
Serious AEs
46.5%
Results posted
Jan 2014
Primary outcomePrimary: Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization — 42; 21 participants — p=0.007
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization |
42; 21 | 0.007 sig |
| SECONDARY Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months |
73; 33 | <0.001 sig |
| SECONDARY Clinician Administered PTSD Scale (CAPS) |
-7.2; -7.0 | — |
| SECONDARY PTSD Checklist |
-3.2; -2.4 | — |
| SECONDARY PTSD Checklist |
-3.2; -2.4 | — |
| SECONDARY PTSD Checklist |
-3.2; -2.4 | — |
| SECONDARY PTSD Checklist |
-3.2; -2.4 | — |
| SECONDARY PTSD Checklist |
-3.2; -2.4 | — |
| SECONDARY PTSD Checklist |
-3.2; -2.4 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
-0.2; -0.3 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
-0.2; -0.3 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
-0.2; -0.3 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
-0.2; -0.3 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
1.1; 1.2 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
-0.2; -0.3 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 7-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Self Reported |
111; 73 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
| SECONDARY 30-day Point Prevalence Abstinence - Bio-Verified |
86; 51 | — |
Eligibility Criteria
Inclusion Criteria
- Receive a minimum of four mental health treatment sessions from the SOPP that span at least a 1-month interval
- SOPP treatment plan must indicate intent to deliver ongoing PTSD care for at least 1 year, including visits at least once per month
- Diagnosis of PTSD resulting from military trauma using DSM-IV criteria
- Current nicotine use, smoking greater at least 10 cigarettes per day for at least 16 of the past 30 days prior to randomization
- Demonstrated motivation to quit smoking
Exclusion Criteria
- Use of smokeless tobacco or smoke pipes or cigars
- Any psychotic disorder that is not in remission
- Bipolar disorder that is not in remission
- Any substance dependence disorder that is not in remission (current substance abuse disorder and substance dependence disorder in remission for more than 1 month are not exclusions)
- Imminent risk for suicide or violence, as determined during routine assessment by SOPP clinical staff
- Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions), as determined during routine assessment by SOPP clinical staff
- Gross impairment from organic mental disorder, as determined during routine assessment by SOPP clinical staff
Data sourced from ClinicalTrials.gov (NCT00118534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.