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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01080092
First received: March 2, 2010
Last updated: December 1, 2011
Last verified: December 2011

March 2, 2010
December 1, 2011
April 2010
March 2011   (final data collection date for primary outcome measure)
Craving at the end of each of two (learning) sessions; [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01080092 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study
Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: breathing technique
    breathing technique as a stress management technique, reinforced by biofeedback
  • Behavioral: behavioral strategies
    the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving
  • Experimental: breathing technique group
    technique as a stress management technique, reinforced by biofeedback
    Intervention: Behavioral: breathing technique
  • Placebo Comparator: no breathing technique
    the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving
    Intervention: Behavioral: behavioral strategies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01080092
2010/020
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Hedwig Boudrez University Hospital, Ghent
University Hospital, Ghent
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP