Trial Outcomes & Findings for Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD) (NCT NCT00908882)

NCT ID: NCT00908882

Last Updated: 2015-06-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 178 participants
• Primary outcome timeframe: During 90-session intervention period
• Results posted on: 2015-06-16

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	89	89
Overall Study COMPLETED	61	59
Overall Study NOT COMPLETED	28	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy	Total n=175 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 11.2 • n=5 Participants	57 years STANDARD_DEVIATION 10.8 • n=7 Participants	55.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	77 Participants n=7 Participants	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	77 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	72 Participants n=7 Participants	144 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	86 participants n=7 Participants	175 participants n=5 Participants
Post Traumatic Stress Disorder Checklist	57 units on a scale STANDARD_DEVIATION 11.9 • n=5 Participants	60 units on a scale STANDARD_DEVIATION 11 • n=7 Participants	58.8 units on a scale STANDARD_DEVIATION 11.5 • n=5 Participants
Geriatric Depression Scale	8.9 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	9.2 units on a scale STANDARD_DEVIATION 3.8 • n=7 Participants	9.1 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Fagerstrom Test of Nicotine Dependence	5.4 units on a scale STANDARD_DEVIATION 2 • n=5 Participants	5 units on a scale STANDARD_DEVIATION 2.3 • n=7 Participants	5.3 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: During 90-session intervention period

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
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	28 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
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	35 participants

PRIMARY outcome

Timeframe: During 90-session intervention period

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.	20 participants	22 participants

PRIMARY outcome

Timeframe: During the 6-month follow-up period

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
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	31 participants

PRIMARY outcome

Timeframe: During the 6-month follow-up period

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.	21 participants	20 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=89 Participants 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	Usual PTSD Health Buddy Care n=86 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
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	21 participants

SECONDARY outcome

Timeframe: At end of 90-session intervention period

Population: These numbers represent those that completed the survey.

range 17-85; >50 indicates PTSD diagnosis

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=62 Participants 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	Usual PTSD Health Buddy Care n=59 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
Post Traumatic Stress Disorder Checklist	54.5 units on a scale Standard Deviation 13.2	55.9 units on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: At the end of the 6-month follow-up period

Population: These numbers represent those that completed the survey.

range 17-85; >50 indicates PTSD diagnosis

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=61 Participants 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	Usual PTSD Health Buddy Care n=59 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
Post Traumatic Stress Disorder Checklist	58.4 units on a scale Standard Deviation 11.4	62.4 units on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: At the end of the 90-session intervention period

Population: These numbers represent those that completed the survey.

range 1-15; >6 indicates depression

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=68 Participants 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	Usual PTSD Health Buddy Care n=62 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
Geriatric Depression Scale	7.9 units on a scale Standard Deviation 4.2	10 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: At the end of the 6-month follow-up period

Population: These numbers represent those who completed the survey.

range 1-15; >6 indicates depression

Outcome measures

Measure	Enhanced PTSD Health Buddy and Motivational Interviewing n=61 Participants 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	Usual PTSD Health Buddy Care n=59 Participants Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
Geriatric Depression Scale	8.4 units on a scale Standard Deviation 4.2	9.8 units on a scale Standard Deviation 3.8

Adverse Events

Enhanced PTSD Health Buddy and Motivational Interviewing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual PTSD Health Buddy Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Battaglia PhD RN

Eastern Colorado Health Care System

Phone: 720-857-5099

Email: catherine.battaglia@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place