NCT04649762

Brief Summary

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. 1.COVI scale
  2. 2.Comfort scale 0 to 10
  3. 3.Management: drugs, TAC, others
  4. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

September 29, 2020

Last Update Submit

December 1, 2020

Conditions

Keywords

hypnosisanxietygeneral practice

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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)

Interventions

activating consciousness technique (hypnosis)

TAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \- Follow-up deemed impossible by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dr Stéphane FOLACHER

Bourg-en-Bresse, 01000, France

RECRUITING

Dr Céline HUMBERT

Lyon, 69008, France

RECRUITING

Dr Matthieu DEMOURGUES

Lyon, 69008, France

RECRUITING

Dr Christian SAINT-CYR

Saint-Étienne-du-Bois, 01370, France

RECRUITING

Dr Aurélien BARADEL

Saint-Martin-du-Frêne, 01430, France

RECRUITING

Dr Maud BINARD

Villereversure, 01250, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26944812BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

December 2, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

December 2, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations