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

Primary Purpose

Tobacco Use Cessation, Post Traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivation Interviewing Counseling
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Use Cessation focused on measuring Nursing Care, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Eastern Colorado Health Care System, Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced PTSD Health Buddy and Motivational Interviewing

Usual PTSD Health Buddy Care

Arm Description

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

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

Outcomes

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).
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)
Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.
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).
Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.
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)

Secondary Outcome Measures

Post Traumatic Stress Disorder Checklist
range 17-85; >50 indicates PTSD diagnosis
Post Traumatic Stress Disorder Checklist
range 17-85; >50 indicates PTSD diagnosis
Geriatric Depression Scale
range 1-15; >6 indicates depression
Geriatric Depression Scale
range 1-15; >6 indicates depression

Full Information

First Posted
May 22, 2009
Last Updated
June 8, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00908882
Brief Title
Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD)
Official Title
Telehealth Care Management and Tobacco Cessation for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Post Traumatic Stress Disorders
Keywords
Nursing Care, Veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced PTSD Health Buddy and Motivational Interviewing
Arm Type
Experimental
Arm Description
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
Arm Title
Usual PTSD Health Buddy Care
Arm Type
No Intervention
Arm Description
Veteran with PTSD who smoke randomly assigned to this arm received standard of care for smoking cessation and used the standard PTSD Health Buddy
Intervention Type
Behavioral
Intervention Name(s)
Motivation Interviewing Counseling
Intervention Description
Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions
Primary Outcome Measure Information:
Title
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
Title
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.
Description
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)
Time Frame
During 90-session intervention period
Title
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
Title
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
Title
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
Title
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.
Description
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)
Time Frame
During the 6-month follow-up period
Secondary Outcome Measure Information:
Title
Post Traumatic Stress Disorder Checklist
Description
range 17-85; >50 indicates PTSD diagnosis
Time Frame
At end of 90-session intervention period
Title
Post Traumatic Stress Disorder Checklist
Description
range 17-85; >50 indicates PTSD diagnosis
Time Frame
At the end of the 6-month follow-up period
Title
Geriatric Depression Scale
Description
range 1-15; >6 indicates depression
Time Frame
At the end of the 90-session intervention period
Title
Geriatric Depression Scale
Description
range 1-15; >6 indicates depression
Time Frame
At the end of the 6-month follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Battaglia, PhD MS BS
Organizational Affiliation
Denver VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Eastern Colorado Health Care System, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23644676
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: 10.1177/1078390313485907. No abstract available.
Results Reference
result
PubMed Identifier
23644675
Citation
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.
Results Reference
result
PubMed Identifier
25638351
Citation
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.
Results Reference
derived

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

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