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

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ClinicalTrials.gov Identifier: NCT01080092
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: breathing technique Behavioral: behavioral strategies Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study
Study Start Date : April 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Craving at the end of each of two (learning) sessions; [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080092


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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01080092     History of Changes
Other Study ID Numbers: 2010/020
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

Keywords provided by University Hospital, Ghent:
smokers