PATH Partnering to Achieve Tobacco-free Health

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Smoking Cessation

Treatments: Other: Acceptance & Commitment Therapy (ACT); Other: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01533974

IR7441

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

ACT

Experimental group

Description:

We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.

Treatment:

Other: Acceptance & Commitment Therapy (ACT)

CBT

Active Comparator group

Treatment:

Other: Cognitive Behavioral Therapy (CBT)