PATH Partnering to Achieve Tobacco-free Health

NCT ID: NCT01533974

Last Updated: 2016-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-01-31

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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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ACT

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

Group Type EXPERIMENTAL

Acceptance & Commitment Therapy (ACT)

Intervention Type OTHER

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

CBT

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type OTHER

The control condition will be the current group-delivered CBT smoking cessation program at GH.

Interventions

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Acceptance & Commitment Therapy (ACT)

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

Intervention Type OTHER

Cognitive Behavioral Therapy (CBT)

The control condition will be the current group-delivered CBT smoking cessation program at GH.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Bricker

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Group Health Cooperative

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

Reference Type DERIVED
PMID: 35420700 (View on PubMed)

Other Identifiers

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IR7441

Identifier Type: -

Identifier Source: org_study_id

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