PATH Partnering to Achieve Tobacco-free Health

Study Overview
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Brief Summary
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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.

Official Title
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Acceptance & Commitment Therapy for Smoking Cessation (Aka PATH Study - Partnering to Achieve Tobacco-free Health)

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Acceptance & Commitment Therapy (ACT)
* Other: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT<br>We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. | Other: Acceptance & Commitment Therapy (ACT)<br>* We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.<br>|
| Active Comparator: CBT<br> | Other: Cognitive Behavioral Therapy (CBT)<br>* The control condition will be the current group-delivered CBT smoking cessation program at GH.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Stopped Smoking by 12 Month Post Treatment | 30 day point prevalence abstinence at 12 months. Missing = smoking and self report. | 12 months |