Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial

BACKGROUND Smoking remains the leading cause of preventable illness and mortality in the United States. Individuals with Posttraumatic Stress Disorder (PTSD) have smoking rates higher than that of others and fewer individuals with PTSD have quit smoking. This randomized controlled trial was designed to test the effectiveness of integrating telehealth care management and smoking cessation with motivational interviewing for Veterans with PTSD. METHODS/DESIGN All smokers with PTSD, regardless of their desire to quit, were invited to participate. Enrollment occurred between November 2009 and April 2013. Target enrollment was 120 participants. Enrolled participants were randomized to either the control group, receiving usual care including a telehealth PTSD program, with a device that delivered PTSD information and in-home care management, or the intervention group, which included (1) a telehealth PTSD program, (2) motivational interviewing-based smoking cessation curricula via the telehealth device, and (3) weekly motivational interviewing counseling phone calls. Outcomes are self-reported 24-hour quit attempts, progression along the stages of change and 7-day point prevalence quit smoking rates for the intervention group compared to usual care alone. Secondary outcomes include participants' perception of care coordination, patient satisfaction with motivational interviewing, PTSD symptoms, pain, depression and quality of life. DISCUSSION Motivational interviewing has been shown to increase readiness for change and smoking cessation care has been shown to be more successful when incorporated into in-person mental health care. Our study builds on previous studies. It integrates a written smoking cessation curriculum and phone-based motivational interviewing counseling into an established PTSD home telehealth care coordination program. This paper describes the design and methods of our randomized control trial. TRIAL REGISTRATION ClinicalTrials.gov, NCT00908882, May 22, 2009.