Clinical trial NCT00118534: Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
Official title: CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Tobacco Use Disorder
Keywords: addictive disorders
clinical trial
cost effectiveness
mental health
military or environmental exposure
multi-site trial
nicotine
nicotine replacement
post traumatic stress
post traumatic stress disorder
psychiatric
psychological
PTSD
smoking cessation
smoking cessation medications
substance abuse
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-11
Enrollment: 943
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Intervention: The research will test the effectiveness of integrating evidence-based, efficacious treatments for tobacco use disorder into mental health care for patients with chronic PTSD. Two different methods for delivering smoking cessation treatment will be compared in a randomized, controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD who want to quit smoking will be randomly assigned to either (1) guideline-concordant smoking cessation treatment integrated within ongoing mental health care for PTSD, and delivered by mental health providers (Integrated Care (IC), experimental condition), or (2) specialized smoking cessation treatment, delivered separately from PTSD treatment by a smoking cessation clinic (Usual Standard of Care (USC), comparison condition).

Primary Hypothesis: IC will be more effective than USC on measures of smoking-related clinical outcomes.

Secondary Hypothesis: The following treatment process variables will predict smoking abstinence at 12-months post randomization: (a) number of smoking cessation treatment sessions received, (b) type and duration of protocol medications prescribed by providers (bupropion, transdermal nicotine patch, and nicotine gum), (c) degree of subjects' compliance with prescribed protocol medication, and (d) number of quit attempts marked by abstinence of 7 days or more.

Treatment process variables that predict smoking abstinence will be present to a significantly greater degree in IC than USC.

Primary Outcomes: The primary outcome measure will be the point-prevalence of smoking abstinence by self-report for the 7 days prior to assessments, obtained at months 3, 6, 9, and 12 following randomization to study conditions. Verification of smoking abstinence will be obtained by CO readings (abstinence \< 10 ppm) obtained at each assessment interval. Salivary cotinine levels (abstinence \< 20 ng/ml) will be measured to verify abstinence at months 9 and 12 only, as subjects may still be using nicotine replacement medicines at earlier assessment intervals, confounding cotinine assays.

Study Abstract: Individuals with posttraumatic stress disorder (PTSD) are far more likely to smoke than those without mental illness and they smoke more heavily. Tobacco use likely contributes to the heightened overall mortality and specific risks for smoking related diseases among veterans with PTSD and commonly co-occurring mental disorders.

Symptoms of PTSD and associated mental disorders are linked to the maintenance of tobacco dependence, premature dropout from smoking cessation treatment, and relapse to smoking following quit attempts. Many efficacious tobacco use treatments exist, but a number of barriers limit the effectiveness of current methods for delivering these treatments in VA health care settings, particularly for the mentally ill. Novel approaches to smoking cessation for individuals with PTSD are needed to circumvent these barriers by integrating evidence-based tobacco use treatment into ongoing mental health care. The research proposed here will test the effectiveness of integrating evidence-based treatment for nicotine dependence into mental health care for patients with chronic posttraumatic stress disorder (PTSD). Two different methods for delivering smoking cessation treatment will be compared in a prospective, randomized controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD (n=440) will be randomly assigned to either: (1) practice guideline-concordant smoking cessation treatment that is integrated within ongoing mental health care for PTSD and delivered by mental health providers (Integrated Care \[IC\]) or 2) smoking cessation treatment delivered separately from PTSD treatment by smoking cessation specialists (Usual Standard of Care \[USC\]). Specific aims of the proposed investigation are (1) to demonstrate that IC is more effective than USC in reducing smoking in psychiatric patients with PTSD and (2) to demonstrate that a number of treatment process variables, including the amount or dose of intervention and patient-specific factors, predict abstinence from tobacco use in smokers with PTSD. Intent-to-treat analyses and analyses for treatment completers will be conducted, using a Generalized Estimating Equations approach. If the study hypothesis is confirmed, system-wide implementation of the experimental intervention (IC) for veterans with PTSD would double the number of patients who stop smoking compared to the usual standard of care for tobacco use disorder. Study findings may have implications for integrating smoking cessation treatment into mental health care for patients with disorders other than PTSD.

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

Primary outcomes:
measure: Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization
timeFrame: between 6 and 18 months
Secondary outcomes:
measure: Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months
timeFrame: between 6 and 18 months
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Baseline and 18 months
measure: PTSD Checklist
timeFrame: Baseline and 3 months
measure: PTSD Checklist
timeFrame: Baseline and 6 months
measure: PTSD Checklist
timeFrame: Baseline and 9 months
measure: PTSD Checklist
timeFrame: Baseline and 12 months
measure: PTSD Checklist
timeFrame: Baseline and 15 months
measure: PTSD Checklist
timeFrame: Baseline and 18 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 3 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 6 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 9 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 12 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 15 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 18 months
measure: 7-day Point Prevalence Abstinence - Self Reported
timeFrame: 3 months
measure: 7-day Point Prevalence Abstinence - Self Reported
timeFrame: 6 months
measure: 7-day Point Prevalence Abstinence - Self Reported
timeFrame: 9 months
measure: 7-day Point Prevalence Abstinence - Self Reported
timeFrame: 12 months
measure: 7-day Point Prevalence Abstinence - Self Reported
timeFrame: 15 months
measure: 7-day Point Prevalence Abstinence - Self Reported
timeFrame: 18 months
measure: 7-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 3 months
measure: 7-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 6 months
measure: 7-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 9 months
measure: 7-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 12 months
measure: 7-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 15 months
measure: 7-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 18 months
measure: 30-day Point Prevalence Abstinence - Self Reported
timeFrame: 3 months
measure: 30-day Point Prevalence Abstinence - Self Reported
timeFrame: 6 months
measure: 30-day Point Prevalence Abstinence - Self Reported
timeFrame: 9 months
measure: 30-day Point Prevalence Abstinence - Self Reported
timeFrame: 12 months
measure: 30-day Point Prevalence Abstinence - Self Reported
timeFrame: 15 months
measure: 30-day Point Prevalence Abstinence - Self Reported
timeFrame: 18 months
measure: 30-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 3 months
measure: 30-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 6 months
measure: 30-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 9 months
measure: 30-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 12 months
measure: 30-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 15 months
measure: 30-day Point Prevalence Abstinence - Bio-Verified
timeFrame: 18 months
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: VA Medical Center, Tuscaloosa
state: Alabama
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
city: Washington
country: United States
facility: VA Medical Center, DC
state: District of Columbia
city: New Orleans
country: United States
facility: Southeast Veterans Healthcare System, New Orleans
state: Louisiana
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: VA Medical Center, Providence
state: Rhode Island
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: Hampton
country: United States
facility: VA Medical Center, Hampton
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System, Seattle
name: Miles E McFall, PhD
role: STUDY_CHAIR
References:
citation: Smith MW, Chen S, Siroka AM, Hamlett-Berry K. Using policy to increase prescribing of smoking cessation medications in the VA healthcare system. Tob Control. 2010 Dec;19(6):507-11. doi: 10.1136/tc.2009.035147. Epub 2010 Sep 24.
citation: McFall M, Saxon AJ, Malte CA, Chow B, Bailey S, Baker DG, Beckham JC, Boardman KD, Carmody TP, Joseph AM, Smith MW, Shih MC, Lu Y, Holodniy M, Lavori PW; CSP 519 Study Team. Integrating tobacco cessation into mental health care for posttraumatic stress disorder: a randomized controlled trial. JAMA. 2010 Dec 8;304(22):2485-93. doi: 10.1001/jama.2010.1769.
citation: Barnett PG, Jeffers A, Smith MW, Chow BK, McFall M, Saxon AJ. Cost-Effectiveness of Integrating Tobacco Cessation Into Post-Traumatic Stress Disorder Treatment. Nicotine Tob Res. 2016 Mar;18(3):267-74. doi: 10.1093/ntr/ntv094. Epub 2015 May 4.
citation: Joseph AM, McFall M, Saxon AJ, Chow BK, Leskela J, Dieperink ME, Carmody TP, Beckham JC. Smoking intensity and severity of specific symptom clusters in posttraumatic stress disorder. J Trauma Stress. 2012 Feb;25(1):10-6. doi: 10.1002/jts.21670. Epub 2012 Feb 10.
citation: Harder LH, Chen S, Baker DG, Chow B, McFall M, Saxon A, Smith MW. The influence of posttraumatic stress disorder numbing and hyperarousal symptom clusters in the prediction of physical health status in veterans with chronic tobacco dependence and posttraumatic stress disorder. J Nerv Ment Dis. 2011 Dec;199(12):940-5. doi: 10.1097/NMD.0b013e3182392bfb.