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Completed

NCT Number: NCT01533974

PATH 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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Group Health Cooperative

Seattle, Washington, 98101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 and older;
  • smoke at least 10 cigarettes per day for every day in the past month;
  • want to quit smoking in the next 30 days;
  • are able to speak and read in English;
  • are a GH member enrolled living in the greater Seattle area;
  • are not currently participating in other smoking cessation interventions;
  • not currently using other nicotine products (e.g., smokeless tobacco)
  • are willing to attend five 90-minute group intervention sessions and to receive NRT over the next 3 months;
  • 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);
  • no household member currently enrolled in the study

Exclusion criteria

  • fails to meet the eligibility criteria above;
  • 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

Treatment and study plan

Acceptance & Commitment Therapy (ACT)

Other

We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.

Cognitive behavioral therapy (CBT)

Other

The control condition will be the current group-delivered CBT smoking cessation program at GH.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Kaiser Permanente

Registry information

Official study title

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

Acronym: PATH

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2012
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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