Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

Study Overview
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Brief Summary
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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

Official Title
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Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Acceptance Therapy (ACT)
* Other: Cognitive Behavioral Therapy (CBT)


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Stopped Smoking by 6 Month Post Treatment | 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 | 7-day and 24-hour point prevalence quit rates | 6-month |