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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00908882
First received: May 22, 2009
Last updated: June 8, 2015
Last verified: June 2015
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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). [ Time Frame: During 90-session intervention period ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: During 90-session intervention period ] [ Designated as safety issue: No ]

    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)

  • Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. [ Time Frame: During 90-session intervention period ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: During the 6-month follow-up period ] [ Designated as safety issue: No ]
  • Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. [ Time Frame: During the 6-month follow-up period ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: During the 6-month follow-up period ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Post Traumatic Stress Disorder Checklist [ Time Frame: At end of 90-session intervention period ] [ Designated as safety issue: Yes ]
    range 17-85; >50 indicates PTSD diagnosis

  • Post Traumatic Stress Disorder Checklist [ Time Frame: At the end of the 6-month follow-up period ] [ Designated as safety issue: Yes ]
    range 17-85; >50 indicates PTSD diagnosis

  • Geriatric Depression Scale [ Time Frame: At the end of the 90-session intervention period ] [ Designated as safety issue: Yes ]
    range 1-15; >6 indicates depression

  • Geriatric Depression Scale [ Time Frame: At the end of the 6-month follow-up period ] [ Designated as safety issue: Yes ]
    range 1-15; >6 indicates depression


Enrollment: 178
Study Start Date: July 2009
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908882

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Investigators
Principal Investigator: Catherine Battaglia, PhD MS BS Department of Veterans Affairs
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: April 20, 2015
Last Updated: June 8, 2015
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 July 30, 2015