Clinical trial NCT01001546: Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
Official title: Internet-Based Smoking Cessation for OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Veterans
Smoking cessation
Operation Enduring Freedom
Operation Iraqi Freedom
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-10-26
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching aim of the study is to evaluate in a randomized trial the impact of an internet intervention compared to a standard clinic-based control group to promote smoking cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.

Detailed description: Project Background: Veterans returning from Iraq and Afghanistan are smoking at high rates and are at elevated risk for the development of smoking related illness. Intensive speciality clinic-based tobacco cessation programs have high efficacy, are more cost effective than less intensive approaches, and are employed by most VA medical centers. These programs, however, are infrequently attended by veterans, limiting the impact on prevalence, disease burden, and economic costs of smoking. An internet-based smoking cessation intervention could be an effective, low-cost method to implement evidence based smoking cessation principles. The internet could significantly increase the impact of smoking cessation efforts over current approaches by avoiding barriers that limit utilization of existing clinic-based services.

Project Objectives: The goal of the study is to evaluate the impact of an internet-based intervention in comparison to standard VA speciality clinic-based care in promoting smoking cessation in returning veterans. Accordingly, the specific aims and hypotheses are:

AIM 1: To evaluate the impact of an internet-based smoking cessation intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 3 months and 12-month post-treatment follow-ups.

Hypothesis 1: Abstinence rates will be significantly higher among veterans randomized to the web-based intervention than those randomized to VA specialty cessation care.

AIM 2: To evaluate the impact of an internet-based smoking cessation intervention on reach of smoking cessation treatment.

Hypothesis 2.1: Internet-based treatment will result in increased reach as measured by the proportion of patients who access care. Hypothesis 2.2: Internet-based treatment will result in engagement in treatment as measured by the proportion of patients that make at least one quit attempt.

AIM 3: To evaluate the relative cost-effectiveness of the standard specialty care intervention to the web-based intervention.

Project Methods: Proposed is a trial in which 410 OEF/OIF veteran smokers will be randomized to receive either an internet-based smoking cessation intervention and nicotine replacement therapy or referral to VA specialty smoking cessation care, which includes behavioral therapy, group counseling, telephone counseling, self-help materials, and choice of smoking cessation aid (pharmacotherapy).

Participating patients will be surveyed at 3 months post-intervention and at 12 months. The primary outcome of the trial is a 7-day point prevalence abstinence at the 3-month post intervention follow-up, as measured by self-report and verified by cotinine assay.

Eligibility criteria: Inclusion Criteria:

* Enrolled in DVAMC for ongoing care
* Served during OEF/OIF
* Current smokers willing to make a quit attempt in the next 30 days

Exclusion Criteria:

* Active diagnosis of psychosis in the medical record
* Diagnosis of severe dementia in the medical record
* Does not have access to a telephone
* Severely impaired hearing or speech (veterans must be able to respond to phone calls)
* Refusal to provide informed consent

Primary outcomes:
measure: The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)
timeFrame: 3 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Patrick S. Calhoun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26.
citation: Zaborowski DE, Dedert EA, Straits-Troster K, Lee S, Wilson SM, Calhoun PS, Moore SD, Acheson S, Hamlett-Berry KW, Beckham JC. Public health clinical demonstration project for smoking cessation in american veterans who served since september 11, 2001. J Addict Med. 2011 Mar;5(1):79-83. doi: 10.1097/ADM.0b013e3181df97d5.
citation: Calhoun PS, Levin HF, Dedert EA, Johnson Y; VA Mid-Atlantic Mental Illness Research, Education, Clinical Center Registry Workgroup; Beckham JC. The relationship between posttraumatic stress disorder and smoking outcome expectancies among U.S. military veterans who served since September 11, 2001. J Trauma Stress. 2011 Jun;24(3):303-8. doi: 10.1002/jts.20634. Epub 2011 Apr 26.
citation: Straits-Troster K, Acheson S, Beckham JC, Calhoun PS, Gierisch JM, Hamlett-Berry K. Tobacco use and cessation among returning combat veterans: A mixed methods study. [Abstract]. Behavioral medicine update : a publication of the Society of Behavioral Medicine. 2010 Apr 10; 39(S1).
citation: Gierisch JM, Straits-Troster K, Calhoun PS, Beckham JC, Acheson S, Hamlett-Berry K. Tobacco use among Iraq- and Afghanistan-era veterans: a qualitative study of barriers, facilitators, and treatment preferences. Prev Chronic Dis. 2012;9:E58. doi: 10.5888/pcd9.110131. Epub 2012 Feb 16.