Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD)

Tobacco Use Cessation Clinical Trial

Official title:

Telehealth Care Management and Tobacco Cessation for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908882
• Other study ID #: NRI 08-117
• Secondary ID: COMIRB 08-0556
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: June 8, 2015
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Post Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tobacco Use Cessation

Intervention

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

Locations

Country	Name	City	State
United States	VA Eastern Colorado Health Care System, Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		During 90-session intervention period	No
Primary	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.	Transtheoretical Model of Change questionnaire: Are you currently a smoker?; Yes, I currently smoke (move to For Smokers Only section); No, I quit within the last 6 months (ACTION STAGE); No, I quit more than 6 months ago (MAINTENANCE STAGE); No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?; (For smokers only) Are you seriously thinking of quitting smoking?; Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE); Yes, within the next 6 months (CONTEMPLATION STAGE); No, not thinking of quitting (PRECONTEMPLATION STAGE)	During 90-session intervention period	No
Primary	Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.		During 90-session intervention period	No
Primary	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).		During the 6-month follow-up period	No
Primary	Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.		During the 6-month follow-up period	No
Primary	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.	Are you currently a smoker?; Yes, I currently smoke (move to For Smokers Only section); No, I quit within the last 6 months (ACTION STAGE); No, I quit more than 6 months ago (MAINTENANCE STAGE); No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?; (For smokers only) Are you seriously thinking of quitting smoking?; Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE); Yes, within the next 6 months (CONTEMPLATION STAGE); No, not thinking of quitting (PRECONTEMPLATION STAGE)	During the 6-month follow-up period	No
Secondary	Post Traumatic Stress Disorder Checklist	range 17-85; >50 indicates PTSD diagnosis	At end of 90-session intervention period	Yes
Secondary	Post Traumatic Stress Disorder Checklist	range 17-85; >50 indicates PTSD diagnosis	At the end of the 6-month follow-up period	Yes
Secondary	Geriatric Depression Scale	range 1-15; >6 indicates depression	At the end of the 90-session intervention period	Yes
Secondary	Geriatric Depression Scale	range 1-15; >6 indicates depression	At the end of the 6-month follow-up period	Yes