Behavioral Therapy for Reduction in Smoking Craving

Not Applicable

Completed

• Conditions: Tobacco Dependence; Smoking Cessation
• Interventions: Behavioral: standard cognitive behavioral therapy; Behavioral: Mindfulness Based Cognitive Therapy

• Registration Number: NCT00449293
• Lead Sponsor: University of Pittsburgh

Brief Summary

The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.

Detailed Description

The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. The specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. A secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. Daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. Participants completed questionnaires and a brief computer-based cognitive testing paradigm. Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-03-16
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-20
• Primary Completion: 2007-06
• Status Verified: 2008-01
• Study Completion: 2008-05
• Last Update Submitted: 2017-05-26
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase).
• Subjects must smoke at least 10 cigarettes per day
• Must be at least 18 years old
• English speaking
• Able to read, understand, and complete a written questionnaire
• Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice
• Must not currently be using pharmacologic therapy to quit
• Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment.
• Only strongly right-handed subjects will be included

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Exclusion Criteria

• Pregnant women
• Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work)
• Weigh over 300 pounds
• Known problem of claustrophobia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	standard cognitive behavioral therapy	-
2	Mindfulness Based Cognitive Therapy	-

Primary Outcome Measures

Name	Time	Method
Participant acceptability of novel behavioral intervention (mindfulness)	baseline - session 8
Feasibility of recruitment and retention of participants	baseline - session 8 and 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Smoking cessation	baseline - session 8 and 6 month follow-up
Exhaled CO readings	baseline, sessions 5 & 8
Salivary cotinine measures	baseline and sessions 5 & 8
Perceived Stress Scale	baseline & session 8
Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)	Sessions 1,5, & 8
Trait Self-Control Scale	baseline & session 8
Positive and Negative Affect Scale	baseline & session 8
Difficulties in Emotional Regulation Scale	baseline & session 8
Craving response from a smoking cue (fMRI)	Sessions 1,5, & 8
Psychological Measures	baseline & session 8
Self Reported Measures:	baseline, sessions 5 & 8
State Ego Depletion Scale	baseline & session 8
Snaith-Hamilton Hedonic Capacity Scale	baseline & session 8
Kentucky Inventory of Mindfulness Scales	baseline & session 8
Self-Efficacy Scale	baseline & session 8
Mindful Attention Awareness Scale	baseline & session 8
Mindfulness meditation practice (mindfulness participants only, time in minutes	sessions 1-8

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States