NCT01525420

Brief Summary

The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT). Implementation outcomes:

  • end of treatment and 6-month follow-up data retention rates;
  • intervention implementation quality;
  • number \& length of calls completed. Comparison of each arm's implementation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

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

First Submitted

Initial submission to the registry

January 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 16, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

January 31, 2012

Results QC Date

March 10, 2014

Last Update Submit

May 7, 2014

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Stopped Smoking by 6 Month Post Treatment

    30-Day point prevalence abstinence at 6 months post treatment

    6 months

Secondary Outcomes (1)

  • 7-day and 24-hour Point Prevalence Quit Rates

    6-month

Study Arms (2)

ACT

EXPERIMENTAL

ACT: This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.

Behavioral: Acceptance Therapy (ACT)

CBT

ACTIVE COMPARATOR

CBT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.

Other: Cognitive Behavioral Therapy (CBT)

Interventions

Acceptance Therapy (ACT)BEHAVIORAL

ACT

ACT
Cognitive Behavioral Therapy (CBT)OTHER

CBT

CBT

Eligibility Criteria

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

You may qualify if:

  • aged 18 and older;
  • smokes at least 10 cigarettes daily and has done so for at least the past 12 months;
  • wants to quit smoking in the next 30 days;
  • willing to be randomly assigned to either group;
  • willing and able to speak and read in English;
  • willing and medically eligible to use nicotine replacement therapy (NRT),
  • currently resides in the U.S., and expects to continue for at least 12 months;
  • not participating in other smoking cessation interventions;
  • has regular access to a telephone.
  • has regular access to an email address.

You may not qualify if:

  • another member of household enrolled in the study;
  • currently using medication or nicotine replacement products to help with quitting smoking;
  • currently using any non-cigarette tobacco products;
  • pregnant or breastfeeding;
  • had a heart attack in last 30 days;
  • within the last 6 months, diagnosed with angina, heart pain, or irregular heartbeat;
  • serious adverse reactions to nicotine patches including anaphylaxis and related symptoms such as hives, respiratory difficulty, and/or angioedema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 19024, 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

Interventions

Acceptance and Commitment TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior

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@fhcrc.org

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Member, Public Health Sciences

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 3, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 26, 2014

Results First Posted

April 16, 2014

Record last verified: 2014-05

Locations

US(1)