Phase 2
N=450
PATH Partnering to Achieve Tobacco-free Health
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01533974 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Number of Participants Who Stopped Smoking by 12 Month Post Treatment — 31; 41 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acceptance & Commitment Therapy (ACT) (Other); Cognitive Behavioral Therapy (CBT) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Stopped Smoking by 12 Month Post Treatment |
31; 41 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01533974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.