NCT01533974CompletedPhase 1
Acceptance & Commitment Therapy for Smoking Cessation (Aka PATH Study - Partnering to Achieve Tobacco-free Health)
Fred Hutchinson Cancer Center2 sites in 1 country450 target enrollmentStarted: June 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Number of Participants Who Stopped Smoking by 12 Month Post Treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •aged 18 and older;
- •smoke at least 10 cigarettes per day for every day in the past month;
- •want to quit smoking in the next 30 days;
- •are able to speak and read in English;
- •are a GH member enrolled living in the greater Seattle area;
- •are not currently participating in other smoking cessation interventions;
- •not currently using other nicotine products (e.g., smokeless tobacco)
- •are willing to attend five 90-minute group intervention sessions and to receive NRT over the next 3 months;
- •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);
- •no household member currently enrolled in the study
Exclusion Criteria
- •fails to meet the eligibility criteria above;
- •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
Outcomes
Primary Outcomes
Number of Participants Who Stopped Smoking by 12 Month Post Treatment
Time Frame: 12 months
30 day point prevalence abstinence at 12 months. Missing = smoking and self report.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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