PATH Partnering to Achieve Tobacco-free Health (PATH)

May 13, 2016 updated by: Fred Hutchinson Cancer Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Cooperative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ACT
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)
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
ACTIVE_COMPARATOR: CBT
Other: Cognitive Behavioral Therapy (CBT)
The control condition will be the current group-delivered CBT smoking cessation program at GH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Kaiser Permanente

Investigators

  • Principal Investigator: Jonathan Bricker, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (ESTIMATE)

February 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IR7441

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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