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

NCT ID: NCT01080092

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Keywords

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smokers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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breathing technique group

technique as a stress management technique, reinforced by biofeedback

Group Type EXPERIMENTAL

breathing technique

Intervention Type BEHAVIORAL

breathing technique as a stress management technique, reinforced by biofeedback

no breathing technique

the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving

Group Type PLACEBO_COMPARATOR

behavioral strategies

Intervention Type BEHAVIORAL

the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving

Interventions

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breathing technique

breathing technique as a stress management technique, reinforced by biofeedback

Intervention Type BEHAVIORAL

behavioral strategies

the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hedwig Boudrez

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website of University Hospital Ghent

Other Identifiers

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2010/020

Identifier Type: -

Identifier Source: org_study_id