Smoking Cessation
Conditions
Brief summary
The overall aim of this 5-year project is to capitalize on the strong theoretical and promising empirical evidence for Acceptance & Commitment Therapy (ACT) as an intervention for smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and delivered within a real world healthcare setting.
Interventions
OTHERAcceptance & Commitment Therapy (ACT)
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
OTHERCognitive Behavioral Therapy (CBT)
The control condition will be the current group-delivered CBT smoking cessation program at GH.
Sponsors
Kaiser Permanente
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. aged 18 and older; 2. smoke at least 10 cigarettes per day for every day in the past month; 3. want to quit smoking in the next 30 days; 4. are able to speak and read in English; 5. are a GH member enrolled living in the greater Seattle area; 6. are not currently participating in other smoking cessation interventions; 7. not currently using other nicotine products (e.g., smokeless tobacco) 8. are willing to attend five 90-minute group intervention sessions and to receive NRT over the next 3 months; 9. have no medical contraindications for NRT use (i.e., pregnant, breastfeeding, recent heart attack, or skin allergy preventing use of the patch, as assessed using the standard GH contraindication screening for NRT patch); 10. no household member currently enrolled in the study
Exclusion criteria
1. fails to meet the eligibility criteria above; 2. has a significant cognitive or physical impairment (e.g., dementia, deafness) that would preclude full participation in the counseling sessions. This will be assessed both by self-report and by in-person assessment at the baseline enrollment appointment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Stopped Smoking by 12 Month Post Treatment | 12 months | 30 day point prevalence abstinence at 12 months. Missing = smoking and self report. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 224 |
| Cognitive Behavioral Therapy (CBT) Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH. | 226 |
| Total | 450 |
Baseline characteristics
| Characteristic | Acceptance and Commitment Therapy (ACT) | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 12 | 50.8 years STANDARD_DEVIATION 12.2 | 51.3 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 118 Participants | 119 Participants | 237 Participants |
| Sex: Female, Male Male | 106 Participants | 107 Participants | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 224 | 5 / 226 |
| serious Total, serious adverse events | 0 / 224 | 0 / 226 |
Outcome results
Primary
Number of Participants Who Stopped Smoking by 12 Month Post Treatment
30 day point prevalence abstinence at 12 months. Missing = smoking and self report.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Number of Participants Who Stopped Smoking by 12 Month Post Treatment | 31 participants |
| Cognitive Behavioral Therapy (CBT) | Number of Participants Who Stopped Smoking by 12 Month Post Treatment | 41 participants |