Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Tobacco Use Cessation Post Traumatic Stress Disorders |
Behavioral: Motivation Interviewing Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Telehealth Care Management and Tobacco Cessation for Veterans With PTSD |
- Self-reported Quit Attempts - The primary outcome is the proportion of veteran's who make a self-reported quit attempt (as defined as a 24-hour point prevalence rate). [ Time Frame: Month 3 and Month 9 ] [ Designated as safety issue: No ]
- Self-reported Quit Attempts - Secondary outcomes include: progress in the stages of change as measured by the TTM Stages of Change (short form) questionnaire. This will identify current stage of change for each subject. A seven-day point prevalence [ Time Frame: Month 3 and Month 9 ] [ Designated as safety issue: No ]
- Care Coordination: The primary outcome is the veteran's perception of care coordination as measured by the Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: Month 3 and Month 9 ] [ Designated as safety issue: No ]
- Care Coordination: Secondary outcomes include: patient satisfaction surveys regarding MI counseling and Smoking Cessation content [ Time Frame: Month 3 and Month 9 ] [ Designated as safety issue: No ]
- PTSD Symptoms: The primary outcome is the level of symptoms related to PTSD [ Time Frame: Month 3 and Month 9 ] [ Designated as safety issue: No ]
- PTSD Symptoms secondary outcomes include: Geriatric depression Scale, Suicide Risk, McGill Short Form Pain Questionnaire, SF-12v2 [ Time Frame: Month 3 and Month 9 ] [ Designated as safety issue: No ]
| Enrollment: | 178 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
|
Behavioral: Motivation Interviewing Counseling
Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions
|
|
No Intervention: Arm 2
Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Colorado | |
| VA Eastern Colorado Health Care System, Denver | |
| Denver, Colorado, United States, 80220 | |
| Principal Investigator: | Catherine Battaglia, PhD MS BS | Department of Veterans Affairs |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00908882 History of Changes |
| Other Study ID Numbers: | NRI 08-117, COMIRB 08-0556 |
| Study First Received: | May 22, 2009 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Nursing Care Veterans |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013