Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PATH Partnering to Achieve Tobacco-free Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Group Health Cooperative
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01533974
First received: February 13, 2012
Last updated: June 9, 2014
Last verified: June 2014
  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 Blind (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:
  • Smoking status [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  3. Does not have smoking cessation benefit or has a co-pay for NRT and is not also a Medicare recipient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533974

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

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01533974     History of Changes
Other Study ID Numbers: IR7441
Study First Received: February 13, 2012
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 23, 2014