Trial Outcomes & Findings for Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms (NCT NCT01199380)
NCT ID: NCT01199380
Last Updated: 2022-05-18
Results Overview
7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
184 participants
Primary outcome timeframe
52 weeks post quit date
Results posted on
2022-05-18
Participant Flow
Participant milestones
| Measure |
Standard Treatment (ST)
Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
|
Behavioral Activation for Smoking
Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
96
|
|
Overall Study
COMPLETED
|
78
|
81
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Standard Treatment (ST)
n=88 Participants
Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
|
Behavioral Activation for Smoking
n=96 Participants
Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
45.25 years
STANDARD_DEVIATION 10.38 • n=99 Participants
|
44.02 years
STANDARD_DEVIATION 12.47 • n=107 Participants
|
44.61 years
STANDARD_DEVIATION 11.51 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
65 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=99 Participants
|
96 participants
n=107 Participants
|
184 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeks post quit date7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt
Outcome measures
| Measure |
Standard Treatment (ST)
n=88 Participants
Participants will receive a standard, group smoking cessation treatment equated for contact time, based on the most recent clinical practice guideline for treating tobacco. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will complete between group exercises and will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events. Participants will also receive 8 weeks of the transdermal nicotine patch.
|
Behavioral Activation for Smoking
n=96 Participants
Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
|
|---|---|---|
|
Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date
|
26 Participants
|
19 Participants
|
Adverse Events
Standard Treatment (ST)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Behavioral Activation for Smoking
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Treatment (ST)
n=88 participants at risk
One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
|
Behavioral Activation for Smoking
n=96 participants at risk
Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
1.1%
1/88 • Number of events 1 • 3 years, 8 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
|
0.00%
0/96 • 3 years, 8 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
|
|
Nervous system disorders
Seizure
|
1.1%
1/88 • Number of events 1 • 3 years, 8 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
|
0.00%
0/96 • 3 years, 8 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Throat cancer
|
0.00%
0/88 • 3 years, 8 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
|
1.0%
1/96 • Number of events 1 • 3 years, 8 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place