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Completed

NCT Number: NCT00908882

Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

    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)
  3. 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

  4. 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

  5. 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

  6. 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

    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 outcomes

  1. Post Traumatic Stress Disorder Checklist

    Time frame: At end of 90-session intervention period

    range 17-85; >50 indicates PTSD diagnosis

  2. Post Traumatic Stress Disorder Checklist

    Time frame: At the end of the 6-month follow-up period

    range 17-85; >50 indicates PTSD diagnosis

  3. Geriatric Depression Scale

    Time frame: At the end of the 90-session intervention period

    range 1-15; >6 indicates depression

  4. Geriatric Depression Scale

    Time frame: At the end of the 6-month follow-up period

    range 1-15; >6 indicates depression

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Telehealth Care Management and Tobacco Cessation for Veterans With PTSD

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 27, 2009
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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