Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal (SOPHCIG)

To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.

Study Overview

• Status: Recruiting
• Conditions: Craving; Cigarette Smoking
• Intervention / Treatment: Behavioral: Sophrology

Detailed Description

Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep.

This pilot study could serve as a basis for the development of research on a larger cohort.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvie Ané; Phone Number: +33 0145175035; Email: sylvie.ane@chicreteil.fr
• Study Contact Backup: Name: Aude Sallard; Phone Number: +33 0157023024; Email: aude.sallard@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)
    • Contact: Sylvie Ané; Phone Number: +33 0145175035; Email: sylvie.ane@chicreteil.fr
  • Créteil, France, 94000
    • Recruiting
    • CHU Henri Mondor Service d'addictologie
    • Contact: Sandrine Lemeunier; Email: sandrine.lemeunier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First outpatient consultation in tobacco addiction department
• Consumption greater than or equal to 35 cigarettes per week
• Minimum age: 18 years old / Maximum age: 75 years old
• Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year)
• Commitment by the patient not to practice hypnosis or mindfulness while participating in the study
• Mastering reading and writing skills
• Acceptance to participate in the protocol
• Affiliated to a social security system

Exclusion Criteria:

• Patient-reported psychosis
• Pregnant women
• Participation in other intervention research
• Patient under guardianship or curatorship
• Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sophrology; the patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology	Behavioral: Sophrology; Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.
No Intervention: Control; the patient must make 7 visits with interviews and questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)	Comparison of the inte craving between the sophrology group and the control group at nsity of 6 months after the end of consultations, using the FTCQ-12 questionnaire.	6 months after the end of consultations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cigarettes smoked per day	Number of cigarettes smoked per day	6 months after the end of consultations
Motivation to Quit Smoking by Numerical Scale (0 to 5)	Assessment of Motivation to Quit Smoking	6 months after the end of consultations
Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)	Measuring Confidence in Withdrawal Success	6 months after the end of consultations
Evaluation of sleep by numerical scale (0 to 5)	Evaluation of sleep quality	6 months after the end of consultations
Evaluation of irritability by numerical scale (0 to 5)	Evaluation of irritability levels	6 months after the end of consultations
Fatigue levels by numerical scale (0 to 5)	Evaluation of fatigue levels	6 months after the end of consultations
Fagerström test (0 to 11)	Comparison of dependency	6 months after the end of consultations
CO (carbon monoxide) test	Comparison of the evolution of the CO	6 months after the end of consultations

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Sylvie Ané, Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): December 23, 2024
• Study Completion (Estimated): December 23, 2025

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Sophrology
• Other Study ID Numbers: SOPHCIG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No