Trial Outcomes & Findings for Smoking Cessation for Veterans With Severe and Persistent Mental Illness (NCT NCT00960375)
NCT ID: NCT00960375
Last Updated: 2015-08-18
Results Overview
Number of cigarettes smoked per day for the last 7 days
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
179 participants
Primary outcome timeframe
day
Results posted on
2015-08-18
Participant Flow
Participants attended outpatient mental health programs at the Baltimore, Perry Point, and Washington DC VA Medical Centers. Participants had DSM-IV diagnoses of schizophrenia spectrum disorders, affective psychosis, other psychotic disorder, major depression with psychotic features, or post-traumatic stress disorder.
To ensure functional impairment in line with SMI, participants with PTSD had to have worked less than 25% of the past year or receive disability payment for PTSD.
Participant milestones
| Measure |
BTSCS
BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
|
StSST
The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
87
|
|
Overall Study
COMPLETED
|
72
|
65
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
| Measure |
BTSCS
BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
|
StSST
The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
22
|
Baseline Characteristics
Smoking Cessation for Veterans With Severe and Persistent Mental Illness
Baseline characteristics by cohort
| Measure |
BTSCS
n=92 Participants
BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
|
StSST
n=87 Participants
The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
177 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 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
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
87 participants
n=7 Participants
|
179 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: dayPopulation: All randomized
Number of cigarettes smoked per day for the last 7 days
Outcome measures
| Measure |
BTSCS
n=92 Participants
BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
|
StSST
n=87 Participants
The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day
|
15.4 number of cigarettes
Standard Deviation 9.8
|
14.9 number of cigarettes
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All randomized to condition
Self-reported abstinence from tobacco + breath CO \< 10 ppm
Outcome measures
| Measure |
BTSCS
n=92 Participants
BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
|
StSST
n=87 Participants
The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
|
|---|---|---|
|
Abstinence From Tobacco
|
10 participants
|
6 participants
|
Adverse Events
BTSCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
StSST
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
Dr. Melanie Bennett, Research Health Scientist
V Maryland Healthcare System
Phone: 410-637-1859
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place