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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
 Behavioral: breathing technique
Behavioral: behavioral strategies
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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)


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: breathing technique group
technique as a stress management technique, reinforced by biofeedback
 Behavioral: breathing technique
breathing technique as a stress management technique, reinforced by biofeedback
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
 Behavioral: behavioral strategies
the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080092

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hedwig Boudrez University Hospital, Ghent
  More Information

Additional Information:
website of University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01080092     History of Changes
Other Study ID Numbers: 2010/020
Study First Received: March 2, 2010
Last Updated: December 1, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
smokers

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on June 17, 2013