Clinical trial NCT00908882: Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD)
Official title: Telehealth Care Management and Tobacco Cessation for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Post Traumatic Stress Disorders
Keywords: Nursing Care
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-05-27
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.

Detailed description: Background: Veterans smoke at a higher rate (30%) than the U.S. adult population (21%), and veterans with PTSD have even higher rates of smoking (53-66%). Evidence has shown that any tobacco dependence treatment strategy must be integrated in the health care system because consistent and effective delivery of tobacco cessation requires coordinated interventions. Persistent tobacco users typically cycle through multiple periods of relapse and remission. Veterans with PTSD (279,256 in 2005) who are treated for smoking cessation may need more comprehensive aid to be successful. Failure to appreciate the chronic nature of tobacco dependence may impede comprehensive and consistent treatment. Care management using telehealth has been shown to improve access to care while reducing costs for veterans with chronic diseases and has the potential to coordinate smoking cessation with care for other chronic diseases. Nurses have successfully managed chronic diseases using telehealth by focusing on increasing self-management, positive behaviors and knowledge. Nurses are vital to increasing the level of support in the community through education and motivation and by responding to medical events in order to improve veterans' health.

Objectives: The study is designed to determine if adding motivational counseling and care management using the PTSD Health Buddy to usual care improves smoking quit rates of veterans with PTSD. Specific Aims are to compare: 1) self-reported quit attempts, progression through the stages of change, and quit rates, 2) patient perception of care coordination, and 3) changes in PTSD symptoms in veteran smokers with PTSD who receive a nurse-driven telephonic motivational counseling intervention triggered by responses to stage-based smoking cessation questions in addition to usual care to those who receive usual care only.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV) for diagnosis code 309.81 PTSD
* Willingness to participate
* Currently smoking 1 or more cigarettes per day

Exclusion Criteria:

* Use smokeless tobacco, pipes or cigars instead of cigarettes
* Have imminent risk of suicide or violence
* Have severe psychiatric symptoms or psychosocial instability likely to prevent participation in protocol (provider will assess appropriateness)
* Have clinically apparent gross cognitive impairment
* Unable to connect Health Buddy in home

Primary outcomes:
measure: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).
timeFrame: During 90-session intervention period
measure: Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.
timeFrame: During 90-session intervention period
measure: Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.
timeFrame: During 90-session intervention period
measure: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).
timeFrame: During the 6-month follow-up period
measure: Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.
timeFrame: During the 6-month follow-up period
measure: Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.
timeFrame: During the 6-month follow-up period
Secondary outcomes:
measure: Post Traumatic Stress Disorder Checklist
timeFrame: At end of 90-session intervention period
measure: Post Traumatic Stress Disorder Checklist
timeFrame: At the end of the 6-month follow-up period
measure: Geriatric Depression Scale
timeFrame: At the end of the 90-session intervention period
measure: Geriatric Depression Scale
timeFrame: At the end of the 6-month follow-up period
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver
state: Colorado
Study officials:
affiliation: Denver VA Medical Center
name: Catherine Battaglia, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battaglia C, Stein KF. A clinical translation of the research article titled "Building a tobacco cessation telehealth care management program for veterans with posttraumatic stress disorder". J Am Psychiatr Nurses Assoc. 2013 Mar-Apr;19(2):92-7. doi: 10.1177/1078390313485907. No abstract available.
citation: Battaglia C, Benson SL, Cook PF, Prochazka A. Building a tobacco cessation telehealth care management program for veterans with posttraumatic stress disorder. J Am Psychiatr Nurses Assoc. 2013 Mar-Apr;19(2):78-91. doi: 10.1177/1078390313483314.
citation: Peterson J, Prochazka AV, Battaglia C. Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial. BMC Health Serv Res. 2015 Feb 1;15:46. doi: 10.1186/s12913-015-0706-6.