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

December 1, 2011 updated by: University Hospital, Ghent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Hedwig Boudrez, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2011

Last Update Submitted That Met QC Criteria

December 1, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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