Post Traumatic Stress Disorders, Tobacco Use Cessation
Conditions
Keywords
Nursing Care, Veterans
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.
Interventions
BEHAVIORALMotivation Interviewing Counseling
Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Traumatic Stress Disorder Checklist | At end of 90-session intervention period | range 17-85; \>50 indicates PTSD diagnosis |
| Geriatric Depression Scale | At the end of the 90-session intervention period | range 1-15; \>6 indicates depression |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing Veterans with PTSD who smoke and are exposed to 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
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions | 89 |
| Usual PTSD Health Buddy Care Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy | 86 |
| Total | 175 |
Baseline characteristics
| Characteristic | Enhanced PTSD Health Buddy and Motivational Interviewing | Usual PTSD Health Buddy Care | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 11.2 | 57 years STANDARD_DEVIATION 10.8 | 55.6 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants | 77 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fagerstrom Test of Nicotine Dependence | 5.4 units on a scale STANDARD_DEVIATION 2 | 5 units on a scale STANDARD_DEVIATION 2.3 | 5.3 units on a scale STANDARD_DEVIATION 2.2 |
| Geriatric Depression Scale | 8.9 units on a scale STANDARD_DEVIATION 3.7 | 9.2 units on a scale STANDARD_DEVIATION 3.8 | 9.1 units on a scale STANDARD_DEVIATION 3.7 |
| Post Traumatic Stress Disorder Checklist | 57 units on a scale STANDARD_DEVIATION 11.9 | 60 units on a scale STANDARD_DEVIATION 11 | 58.8 units on a scale STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 72 Participants | 72 Participants | 144 Participants |
| Region of Enrollment United States | 89 participants | 86 participants | 175 participants |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 74 Participants | 77 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 89 | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
Primary
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)
Time frame: During 90-session intervention period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | 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. | 36 participants |
| Usual PTSD Health Buddy Care | 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. | 35 participants |
Primary
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)
Time frame: During the 6-month follow-up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | 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. | 22 participants |
| Usual PTSD Health Buddy Care | 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. | 21 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | 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). | 34 participants |
| Usual PTSD Health Buddy Care | 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). | 28 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | 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). | 24 participants |
| Usual PTSD Health Buddy Care | 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). | 31 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | 20 participants |
| Usual PTSD Health Buddy Care | Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | 22 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | 21 participants |
| Usual PTSD Health Buddy Care | Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | 20 participants |
Secondary
Geriatric Depression Scale
range 1-15; \>6 indicates depression
Time frame: At the end of the 90-session intervention period
Population: These numbers represent those that completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Geriatric Depression Scale | 7.9 units on a scale | Standard Deviation 4.2 |
| Usual PTSD Health Buddy Care | Geriatric Depression Scale | 10 units on a scale | Standard Deviation 4.2 |
Secondary
Geriatric Depression Scale
range 1-15; \>6 indicates depression
Time frame: At the end of the 6-month follow-up period
Population: These numbers represent those who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Geriatric Depression Scale | 8.4 units on a scale | Standard Deviation 4.2 |
| Usual PTSD Health Buddy Care | Geriatric Depression Scale | 9.8 units on a scale | Standard Deviation 3.8 |
Secondary
Post Traumatic Stress Disorder Checklist
range 17-85; \>50 indicates PTSD diagnosis
Time frame: At the end of the 6-month follow-up period
Population: These numbers represent those that completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Post Traumatic Stress Disorder Checklist | 58.4 units on a scale | Standard Deviation 11.4 |
| Usual PTSD Health Buddy Care | Post Traumatic Stress Disorder Checklist | 62.4 units on a scale | Standard Deviation 10.9 |
Secondary
Post Traumatic Stress Disorder Checklist
range 17-85; \>50 indicates PTSD diagnosis
Time frame: At end of 90-session intervention period
Population: These numbers represent those that completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Post Traumatic Stress Disorder Checklist | 54.5 units on a scale | Standard Deviation 13.2 |
| Usual PTSD Health Buddy Care | Post Traumatic Stress Disorder Checklist | 55.9 units on a scale | Standard Deviation 13.5 |