PATH Partnering to Achieve Tobacco-free Health

Smoking Cessation Clinical Trial

— PATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533974
• Other study ID #: IR7441
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 13, 2012
• Last updated: March 4, 2015
• Start date: June 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• Cognitive Behavioral Therapy (CBT)
The control condition will be the current group-delivered CBT smoking cessation program at GH.

Locations

Country	Name	City	State
United States	Group Health Cooperative	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Group Health Cooperative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking status		1 week	No