Trial Outcomes & Findings for PATH Partnering to Achieve Tobacco-free Health (NCT NCT01533974)
NCT ID: NCT01533974
Last Updated: 2016-06-17
Results Overview
30 day point prevalence abstinence at 12 months. Missing = smoking and self report.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
450 participants
Primary outcome timeframe
12 months
Results posted on
2016-06-17
Participant Flow
Participant milestones
| Measure |
Acceptance and Commitment Therapy (ACT)
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
Acceptance \& Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
|
Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
226
|
|
Overall Study
COMPLETED
|
173
|
176
|
|
Overall Study
NOT COMPLETED
|
51
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PATH Partnering to Achieve Tobacco-free Health
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy (ACT)
n=224 Participants
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
Acceptance \& Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
|
Cognitive Behavioral Therapy (CBT)
n=226 Participants
Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 12.0 • n=39 Participants
|
50.8 years
STANDARD_DEVIATION 12.2 • n=41 Participants
|
51.3 years
STANDARD_DEVIATION 12.1 • n=35 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=39 Participants
|
119 Participants
n=41 Participants
|
237 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=39 Participants
|
107 Participants
n=41 Participants
|
213 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 months30 day point prevalence abstinence at 12 months. Missing = smoking and self report.
Outcome measures
| Measure |
Acceptance and Commitment Therapy (ACT)
n=224 Participants
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
Acceptance \& Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
|
Cognitive Behavioral Therapy (CBT)
n=226 Participants
Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
|
|---|---|---|
|
Number of Participants Who Stopped Smoking by 12 Month Post Treatment
|
31 participants
|
41 participants
|
Adverse Events
Acceptance and Commitment Therapy (ACT)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy (CBT)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acceptance and Commitment Therapy (ACT)
n=224 participants at risk
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
Acceptance \& Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
|
Cognitive Behavioral Therapy (CBT)
n=226 participants at risk
Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
|
|---|---|---|
|
General disorders
Disturbed Sleep
|
3.1%
7/224 • Number of events 7 • 1 year
|
0.44%
1/226 • Number of events 1 • 1 year
|
|
General disorders
Skin irritation
|
1.3%
3/224 • Number of events 3 • 1 year
|
0.44%
1/226 • Number of events 1 • 1 year
|
|
General disorders
Muscle Ache
|
0.45%
1/224 • Number of events 1 • 1 year
|
0.44%
1/226 • Number of events 1 • 1 year
|
|
General disorders
Stomach and digestive issues
|
1.3%
3/224 • Number of events 3 • 1 year
|
0.44%
1/226 • Number of events 1 • 1 year
|
|
General disorders
Dry mouth
|
0.45%
1/224 • Number of events 1 • 1 year
|
0.00%
0/226 • 1 year
|
|
General disorders
Headache
|
0.45%
1/224 • Number of events 1 • 1 year
|
0.00%
0/226 • 1 year
|
|
General disorders
MRSA infection
|
0.00%
0/224 • 1 year
|
0.44%
1/226 • Number of events 1 • 1 year
|
|
General disorders
Anxiety
|
0.45%
1/224 • Number of events 1 • 1 year
|
0.00%
0/226 • 1 year
|
Additional Information
Jonathan B. Bricker, Ph.D.
Fred Hutchinson Cancer Research Center
Phone: 206-667-5074
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place