N/A N=178 Randomized Single-blind Health Services Research

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

Tobacco Use Cessation · Post Traumatic Stress Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00908882 ↗

Enrolled (actual)

178

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: 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). — 34; 28 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Motivation Interviewing Counseling (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
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).	24; 31	—
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.	22; 21	—
PRIMARY Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.	21; 20	—
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).	24; 31	—
PRIMARY Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.	21; 20	—
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.	22; 21	—
SECONDARY Post Traumatic Stress Disorder Checklist	58.4; 62.4	—
SECONDARY Post Traumatic Stress Disorder Checklist	58.4; 62.4	—
SECONDARY Geriatric Depression Scale	8.4; 9.8	—
SECONDARY Geriatric Depression Scale	8.4; 9.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00908882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.