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

This study has been completed.
Sponsor:
Collaborator:
Alere Wellbeing
Information provided by (Responsible Party):
Jonathan Bricker, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01525420
First received: January 31, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Smoking
Behavioral: Acceptance Therapy (ACT)
Other: Cognitive Behavioral Therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Number of Participants Who Stopped Smoking by 6 Month Post Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    30-Day point prevalence abstinence at 6 months post treatment


Secondary Outcome Measures:
  • 7-day and 24-hour Point Prevalence Quit Rates [ Time Frame: 6-month ] [ Designated as safety issue: No ]
    7-day and 24-hour point prevalence quit rates


Enrollment: 121
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525420

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 19024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Alere Wellbeing
  More Information

No publications provided

Responsible Party: Jonathan Bricker, Associate Member, Public Health Sciences, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01525420     History of Changes
Other Study ID Numbers: 7445
Study First Received: January 31, 2012
Results First Received: March 10, 2014
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014