the Activating Consciousness Technique (Hypnosis) in General Practice (MG HYPNOSIS)

Evaluation of the Activating Consciousness Technique (Hypnosis) in Anxiety in a General Practice

Anxiety is an emotion considered unpleasant but resulting from a normal phenomenon. It corresponds to an adaptive response to events, to stress and helps to ensure our survival.

On the other hand, it becomes embarrassing when it becomes uncontrollable. It can even lead to interfere with activities of daily living. Thus, we can speak of anxiety disorder.

Anxiety disorders are among the most prevalent psychiatric disorders. They are often associated with other comorbidities such as depression, which makes them more difficult to treat and diagnose.

Different treatments are offered to best treat the patient with anxiety : drug treatment (antidepressants, anxiolytics) ; non-drug (psychotherapy, meditation, cognitive behavioral therapies).

The emergence of hypnosis in medical practice in recent years seems to be a technique that can bring benefits to the patient.

A review of clinical studies does not seem to find a benefit to hypnosis in anxiety disorders. In contrast, a study in children with school phobia showed the effectiveness of hypnosis. The limits addressed by this review seem to relate to the number of people included in the studies. Contrariwise, it has been pointed out that hypnosis can have a beneficial effect in the long term.

Thus, it seems interesting to deepen this technique in the practice of a general practitioner exercising the activating consciousness technique in anxiety.

The study will be composed of patients presenting with anxiety and consulting their general practitioner, with: Group 1, patients consulting a doctor not practicing hypnosis Versus Group 2, patients consulting a doctor practicing hypnosis.

During the first consultation and the following 2 consultations scheduled by the general practitioner (spaced 15 days apart), the following data are noted, in addition to the monitoring usually performed by the doctor:

1. COVI scale
2. Comfort scale 0 to 10
3. Management: drugs, TAC, others
4. Quality of life survey SF36 Patients will be called back at 6 months to reassess quality of life (self-administered survey SF 36) The primary endpoint is to evaluated the change of anxiety from inclusion (J0) to 6 months using COVI scale in the two different groups.

For secondary endpoints, the consumption of drug medicine will be quantified and the quality of life will be measured using Quality of life survey SF36.

Study Overview

• Status: Unknown
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: activating consciousness technique (hypnosis)

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Bourg-en-Bresse, France, 01000
    • Recruiting
    • Dr Stéphane FOLACHER
    • Contact: Stéphane FOLACHER, MD
    • Principal Investigator: Stéphane FOLACHER, MD
  • Lyon, France, 69008
    • Recruiting
    • Dr Céline HUMBERT
    • Contact: Céline HUMBERT, MD
    • Principal Investigator: Céline HUMBERT, MD
  • Lyon, France, 69008
    • Recruiting
    • Dr Matthieu DEMOURGUES
    • Contact: Matthieu DEMOURGUES, MD
    • Principal Investigator: Matthieu DEMOURGUES, MD
  • Saint-Martin-du-Fresne, France, 01430
    • Recruiting
    • Dr Aurélien BARADEL
    • Contact: Auurélien BARADEL, MD
    • Principal Investigator: Aurélien BARADEL, MD
  • Saint-Étienne-du-Bois, France, 01370
    • Recruiting
    • Dr Christian SAINT-CYR
    • Contact: Christian SAINT-CYR, MD
    • Principal Investigator: Christian SAINT-CYR, MD
  • Villereversure, France, 01250
    • Recruiting
    • Dr Maud BINARD
    • Contact: Maud BINARD, MD
    • Principal Investigator: Maud BINARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with anxiety according to DSM V-C criteria: 3 of 6 symptoms

• Agitation or sensation of being overflown or exhausted
• Fatigability
• Difficulty concentrating or memory lapses
• Irritability
• Muscle tension

Description

Inclusion Criteria:

• Male or Female over 18
• Anxiety patient
• Patient who can return for consultation regularly and can be reached by phone
• Patient Not Opposing Participation In Study

Exclusion Criteria:

- Follow-up deemed impossible by the investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Group 1 includes patients with anxiety consulting a doctor not practicing hypnosis
TAC; Group 2 includes patients with anxiety consulting a doctor practicing hypnosis	Behavioral: activating consciousness technique (hypnosis); activating consciousness technique (hypnosis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the score of anxiety from inclusion (J0) to 6 months evaluated byvia COVI scale	COVI scale (questionnaire completed by patients) is a scale that permits to evaluate the clinical anxiety. The range is 0-100. The higher the score, the more the anxiety. The clinical cut-off score is 30.	6 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Pelissolo A. [Hypnosis for anxiety and phobic disorders: A review of clinical studies]. Presse Med. 2016 Mar;45(3):284-90. doi: 10.1016/j.lpm.2015.12.002. Epub 2016 Mar 2. French.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: anxiety; hypnosis; general practice
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 69HCL20_0202

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