Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: breathing technique; Behavioral: behavioral strategies

• Registration Number: NCT01080092
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This project aims to evaluate the effect of stress-management and a short breathing technique, reinforced by means of visualisation , on the experience of craving in smokers who are prepared to stay abstinent for at least 3 hours before the start of the intervention. It is expected that this strategy can provide supplementary gains in craving control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Study Start: 2010-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

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

Inclusion Criteria

• smokers (at least 10 cigarettes/day);
• 18 years of age or older;
• prepared to stay abstinent for 3 hours before the start of the session;
• not prepared to stop smoking;
• Dutch speaking.

Exclusion Criteria

• acute health related problems;
• psychiatric co-morbidities;
• quit attempts in the past 3 months;
• participation in other clinical trials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breathing technique group	breathing technique	technique as a stress management technique, reinforced by biofeedback
no breathing technique	behavioral strategies	the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving

Primary Outcome Measures

Name	Time	Method
Craving at the end of each of two (learning) sessions;	1 day	Measurement by means of participant's estimation of feelings of smoking urge and smoking craving (by means of the Minnesota Nicotine Withdrawal Scale) before and immeadiately after each of two intervention sessions)

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium