NCT01533974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 9, 2016

Completed
Last Updated

June 17, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

February 13, 2012

Results QC Date

April 5, 2016

Last Update Submit

May 13, 2016

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Stopped Smoking by 12 Month Post Treatment

    30 day point prevalence abstinence at 12 months. Missing = smoking and self report.

    12 months

Study Arms (2)

ACT

EXPERIMENTAL

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)

CBT

ACTIVE COMPARATOR
Other: Cognitive Behavioral Therapy (CBT)

Interventions

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.

ACT
Cognitive Behavioral Therapy (CBT)OTHER

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

CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

    PMID: 35420700DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Acceptance and Commitment TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Jonathan B. Bricker, Ph.D.
Organization
Fred Hutchinson Cancer Research Center
jbricker@fredhutch.org
206-667-5074

Study Officials

  • Jonathan Bricker

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 16, 2012

Study Start

June 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 17, 2016

Results First Posted

May 9, 2016

Record last verified: 2016-05

Locations

US(1)