Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2010
CompletedFirst Posted
Study publicly available on registry
March 3, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedDecember 2, 2011
December 1, 2011
11 months
March 2, 2010
December 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
breathing technique group
EXPERIMENTALtechnique as a stress management technique, reinforced by biofeedback
no breathing technique
PLACEBO COMPARATORthe control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving
Interventions
breathing technique as a stress management technique, reinforced by biofeedback
the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving
Eligibility Criteria
You may qualify if:
- smokers (at least 10 cigarettes/day);
- 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.
You may not qualify if:
- acute health related problems;
- psychiatric co-morbidities;
- quit attempts in the past 3 months;
- participation in other clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ghent
Ghent, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hedwig Boudrez
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2010
First Posted
March 3, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 2, 2011
Record last verified: 2011-12