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

NCT00118534 | Completed Results DMC

• 1 other identifier: 519
• Study Type: interventional
• Target: 943
• Locations: 1 country
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization

  The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine \<100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.

  between 6 and 18 months

Secondary Outcomes (38)

• Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months

  between 6 and 18 months

• Clinician Administered PTSD Scale (CAPS)

  Baseline and 18 months

• PTSD Checklist

  Baseline and 3 months

• PTSD Checklist

  Baseline and 6 months

• PTSD Checklist

  Baseline and 9 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Integration of smoking cessation therapy with PTSD therapy.

Behavioral: Integrated Care for Smoking Cessation in PTSD patients

Arm 2

ACTIVE COMPARATOR

Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.

Behavioral: Standard of Care

Interventions

Integrated Care for Smoking Cessation in PTSD patients BEHAVIORAL

Smoking cessation therapy is integrated with PTSD therapy.

Also known as: Integrated Care (IC)

Arm 1

Standard of Care BEHAVIORAL

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

Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of smokeless tobacco or smoke pipes or cigars
• Any psychotic disorder that is not in remission
• Bipolar disorder that is not in remission
• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (11)

VA Medical Center, Tuscaloosa

Tuscaloosa, Alabama, 35404, United States

Location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Medical Center, DC

Washington D.C., District of Columbia, 20422, United States

Location

Southeast Veterans Healthcare System, New Orleans

New Orleans, Louisiana, 70112, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

VA Medical Center, Hampton

Hampton, Virginia, 23667, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (5)

• 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.

  PMID: 20870742 RESULT

• 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.

  PMID: 21139110 RESULT

• 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.

  PMID: 25943761 DERIVED

• 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.

  PMID: 22328334 DERIVED

• 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.

  PMID: 22134452 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Stress Disorders, Post-Traumatic; Substance-Related Disorders; Tobacco Use Disorder; Smoking Cessation

Interventions

Delivery of Health Care, Integrated; Standard of Care

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Health Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Quality of Health Care

Results Point of Contact

• Title: Dr. Miles McFall
• Organization: VA Puget Sound (Seattle)

Miles.McFall@va.gov

(206) 764-2177

Study Officials

• Miles E McFall, PhD

  VA Puget Sound Health Care System, Seattle

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 11, 2005
• Study Start: July 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 5, 2014
• Results First Posted: January 27, 2014

Record last verified: 2014-04

Locations

US (11)