Clinical trial NCT04700306: Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal
Official title: Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Craving
Cigarette Smoking
Keywords: Sophrology
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)
timeFrame: 6 months after the end of consultations
Secondary outcomes:
measure: Number of cigarettes smoked per day
timeFrame: 6 months after the end of consultations
measure: Motivation to Quit Smoking by Numerical Scale (0 to 5)
timeFrame: 6 months after the end of consultations
measure: Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)
timeFrame: 6 months after the end of consultations
measure: Evaluation of sleep by numerical scale (0 to 5)
timeFrame: 6 months after the end of consultations
measure: Evaluation of irritability by numerical scale (0 to 5)
timeFrame: 6 months after the end of consultations
measure: Fatigue levels by numerical scale (0 to 5)
timeFrame: 6 months after the end of consultations
measure: Fagerström test (0 to 11)
timeFrame: 6 months after the end of consultations
measure: CO (carbon monoxide) test
timeFrame: 6 months after the end of consultations
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)
city: Créteil
country: France
facility: CHU Henri Mondor Service d'addictologie
Study officials:
affiliation: Centre Hospitalier Intercommunal Créteil
name: Sylvie Ané
role: PRINCIPAL_INVESTIGATOR
References: