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

NCT04700306 | Terminated

• 1 other identifier: SOPHCIG
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Craving; Cigarette Smoking

Keywords

Sophrology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of cigarettes smoked per day

  6 months after the end of consultations

• Motivation to Quit Smoking by Numerical Scale (0 to 5)

  6 months after the end of consultations

• Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)

  6 months after the end of consultations

• Evaluation of sleep by numerical scale (0 to 5)

  6 months after the end of consultations

• Evaluation of irritability by numerical scale (0 to 5)

  6 months after the end of consultations

Study Arms (2)

Sophrology

EXPERIMENTAL

the patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology

Behavioral: Sophrology

Control

NO INTERVENTION

the patient must make 7 visits with interviews and questionnaires

Interventions

Sophrology BEHAVIORAL

Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.

Sophrology

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (2)

CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)

Créteil, 94000, France

Location

CHU Henri Mondor Service d'addictologie

Créteil, 94000, France

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Sylvie Ané

  Centre Hospitalier Intercommunal Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: January 7, 2021
• Study Start: June 23, 2021
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)