Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy (TALK)

May 7, 2014 updated by: Jonathan Bricker, Fred Hutchinson Cancer Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 19024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • The Exclusion criteria are the opposite of the Inclusion criteria listed above. In addition, the following exclusion criteria also apply:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT
ACT: This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.
Behavioral: Acceptance Therapy (ACT)
ACT
Active Comparator: CBT
CBT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.
Other: Cognitive Behavioral Therapy (CBT)
CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Stopped Smoking by 6 Month Post Treatment
Time Frame: 6 months
30-Day point prevalence abstinence at 6 months post treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day and 24-hour Point Prevalence Quit Rates
Time Frame: 6-month
7-day and 24-hour point prevalence quit rates
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Consumer Wellness Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 7445 (Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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