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

NCT ID: NCT04700306

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2024-09-09

Brief Summary

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

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.

Conditions

Craving; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sophrology

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

Group Type: EXPERIMENTAL

Sophrology

Intervention Type: BEHAVIORAL

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

Control

the patient must make 7 visits with interviews and questionnaires

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sophrology

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Ané

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Intercommunal Créteil

Locations

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

Créteil, , France

CHU Henri Mondor Service d'addictologie

Créteil, , France

Countries

France

Other Identifiers

SOPHCIG

Identifier Type: -

Identifier Source: org_study_id