Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Acceptance Therapy (ACT); Other: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT01525420
• Lead Sponsor: Fred Hutchinson Cancer Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-03-10
• Results First Submitted QC: 2014-03-10
• Results First Posted: 2014-04-16
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT	Acceptance Therapy (ACT)	ACT: This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.
CBT	Cognitive Behavioral Therapy (CBT)	CBT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Stopped Smoking by 6 Month Post Treatment	6 months	30-Day point prevalence abstinence at 6 months post treatment

Secondary Outcome Measures

Name	Time	Method
7-day and 24-hour Point Prevalence Quit Rates	6-month	7-day and 24-hour point prevalence quit rates

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States