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

Telehealth Care Management and Tobacco Cessation for Veterans With PTSD

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation; Post Traumatic Stress Disorders
• Intervention / Treatment: Behavioral: Motivation Interviewing Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • VA Eastern Colorado Health Care System, Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced PTSD Health Buddy and Motivational Interviewing; Veterans with PTSD who smoke are exposed to an intervention which included 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: Usual PTSD Health Buddy Care; Veteran with PTSD who smoke randomly assigned to this arm received standard of care for smoking cessation and used the standard PTSD Health Buddy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Traumatic Stress Disorder Checklist	range 17-85; >50 indicates PTSD diagnosis	At end of 90-session intervention period
Post Traumatic Stress Disorder Checklist	range 17-85; >50 indicates PTSD diagnosis	At the end of the 6-month follow-up period
Geriatric Depression Scale	range 1-15; >6 indicates depression	At the end of the 90-session intervention period
Geriatric Depression Scale	range 1-15; >6 indicates depression	At the end of the 6-month follow-up period

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Catherine Battaglia, PhD MS BS, Denver VA Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 22, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 27, 2009

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Veterans; Nursing Care
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NRI 08-117; COMIRB 08-0556 (Other Identifier: University of Colorado)