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PATH Partnering to Achieve Tobacco-free Health (PATH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533974
First Posted: February 16, 2012
Last Update Posted: June 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
  Purpose
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.

Condition Intervention Phase
Smoking Cessation Other: Acceptance & Commitment Therapy (ACT) Other: Cognitive Behavioral Therapy (CBT) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Acceptance & Commitment Therapy for Smoking Cessation (Aka PATH Study - Partnering to Achieve Tobacco-free Health)

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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.


Enrollment: 450
Study Start Date: June 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533974


Locations
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Kaiser Permanente
Investigators
Principal Investigator: Jonathan Bricker Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01533974     History of Changes
Other Study ID Numbers: IR7441
First Submitted: February 13, 2012
First Posted: February 16, 2012
Results First Submitted: April 5, 2016
Results First Posted: May 9, 2016
Last Update Posted: June 17, 2016
Last Verified: May 2016