AnxietyMG HYPNOSISNCT04649762
the Activating Consciousness Technique (Hypnosis) in General Practice
An observational study of Anxiety, run by Hospices Civils de Lyon at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- activating consciousness technique (hypnosis)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Oct 2020to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Follow-up deemed impossible by the investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Dr Stéphane FOLACHER
Bourg-en-Bresse, 01000
Stéphane FOLACHER, MD
Stéphane FOLACHER, MD
- Recruiting
Dr Céline HUMBERT
Lyon, 69008
Céline HUMBERT, MD
Céline HUMBERT, MD
- Recruiting
Dr Matthieu DEMOURGUES
Lyon, 69008
Matthieu DEMOURGUES, MD
Matthieu DEMOURGUES, MD
- Recruiting
Dr Christian SAINT-CYR
Saint-Étienne-du-Bois, 01370
Christian SAINT-CYR, MD
Christian SAINT-CYR, MD
- Recruiting
Dr Aurélien BARADEL
Saint-Martin-du-Frêne, 01430
Auurélien BARADEL, MD
Aurélien BARADEL, MD
- Recruiting
Dr Maud BINARD
Villereversure, 01250
Maud BINARD, MD
Maud BINARD, MD
About this study
Official title: 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.
Read more
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:
- COVI scale
- Comfort scale 0 to 10
- Management: drugs, TAC, others
- 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.
- Conditions
- Anxiety
- Being tested
- activating consciousness technique (hypnosis)
- Keywords
- hypnosis, anxiety, general practice
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activating consciousness technique (hypnosis)Behavioural
activating consciousness technique (hypnosis)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: activating consciousness technique (hypnosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Oct 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649762
- Sponsor's protocol ID
- 69HCL20_0202
- Acronym
- MG HYPNOSIS
- Status last verified
- Dec 2020
- First submitted
- 29 Sep 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26944812
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Activating Consciousness Technique (Hypnosis) in Anxiety in a General Practice
- ClinicalTrials.gov ID
- NCT04649762
- Acronym / sponsor ID
- MG HYPNOSIS / 69HCL20_0202
- Conditions
- Anxiety
- Keywords
- hypnosis, anxiety, general practice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- COVI scale
- Comfort scale 0 to 10
- Management: drugs, TAC, others
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Group 1 includes patients with anxiety consulting a doctor not practicing hypnosis |
| TAC | – | Behavioral: activating consciousness technique (hypnosis)Group 2 includes patients with anxiety consulting a doctor practicing hypnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Follow-up deemed impossible by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activating consciousness technique (hypnosis)activating consciousness technique (hypnosis) | Behavioural | TAC |
Primary outcome
Change of the score of anxiety from inclusion (J0) to 6 months evaluated byvia COVI scale
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Background: PubMed 26944812Pelissolo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lidwine LAURENT (0626550636 ext. +33, lidwine.laurent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the score of anxiety from inclusion (J0) to 6 months evaluated byvia COVI scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.