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

NCT00908882 | Completed Results DMC

• 2 other identifiers: NRI 08-117COMIRB 08-0556
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Post Traumatic Stress Disorders

Keywords

Nursing Care; Veterans

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Post Traumatic Stress Disorder Checklist

  At end of 90-session intervention period

• Post Traumatic Stress Disorder Checklist

  At the end of the 6-month follow-up period

• Geriatric Depression Scale

  At the end of the 90-session intervention period

• Geriatric Depression Scale

  At the end of the 6-month follow-up period

Study Arms (2)

Enhanced PTSD Health Buddy and Motivational Interviewing

EXPERIMENTAL

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

Usual PTSD Health Buddy Care

NO INTERVENTION

Veteran with PTSD who smoke randomly assigned to this arm received standard of care for smoking cessation and used the standard PTSD Health Buddy

Interventions

Motivation Interviewing Counseling BEHAVIORAL

Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions

Enhanced PTSD Health Buddy and Motivational Interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

Related Publications (3)

• 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.

  PMID: 23644676 RESULT

• 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.

  PMID: 23644675 RESULT

• 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.

  PMID: 25638351 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Catherine Battaglia PhD RN
• Organization: Eastern Colorado Health Care System

catherine.battaglia@va.gov

720-857-5099

Study Officials

• Catherine Battaglia, PhD MS BS

  Denver VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 27, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 16, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-06

Locations

US (1)