PATH Partnering to Achieve Tobacco-free Health

This study is currently recruiting participants.
Verified April 2013 by Fred Hutchinson Cancer Research Center
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: April 8, 2013
Last verified: April 2013

February 13, 2012
April 8, 2013
June 2011
June 2014   (final data collection date for primary outcome measure)
Smoking status [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01533974 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PATH Partnering to Achieve Tobacco-free Health
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Smoking Cessation
  • 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.
  • Other: Cognitive Behavioral Therapy (CBT)
    The control condition will be the current group-delivered CBT smoking cessation program at GH.
  • Experimental: ACT
    We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
    Intervention: Other: Acceptance & Commitment Therapy (ACT)
  • Active Comparator: CBT
    Intervention: Other: Cognitive Behavioral Therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Not Provided
United States
 
NCT01533974
IR7441
Yes
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Group Health Cooperative
Principal Investigator: Jonathan Bricker Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP