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PATH Partnering to Achieve Tobacco-free Health (PATH)

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ClinicalTrials.gov Identifier: NCT01533974
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : May 9, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Cessation Other: Acceptance & Commitment Therapy (ACT) Other: Cognitive Behavioral Therapy (CBT) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
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)
Study Start Date : June 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.



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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

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

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