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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080092
• Other study ID #: 2010/020
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2010
• Last updated: December 1, 2011
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• breathing technique
breathing technique as a stress management technique, reinforced by biofeedback
• behavioral strategies
the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving at the end of each of two (learning) sessions;	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)	1 day	No

External Links

•   website of University Hospital Ghent