Phobic FearRENCT04165954
Treating Phobia by a New Emotional Regulation Method (Tipi)
An observational study of Phobic Fear, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background In emotional regulation, the patient remembers an emotional situation, focuses his attention on his physical sensations when he relives a recent emotion, and let evolve his sensations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Phobic Fear
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2003to 30 Dec 2006
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with a phobic fear listed in the DSM IV classification
Who may be able to join
- Adult: 18-90 years old
- Adult People with phobic fear in the DSM IV classification
- Phobic people: agoraphobia, with or without panic associated, social phobias and specific phobias. Diagnosis of phobias must be established by the medical world during consultations and explorations. This is systematically checked with the patient to see if the fears come under a phobia as defined in the DSM IV, reference at the time in 2006 (ref DSM IV). The list of phobias classified by type is as follows: animal type or insects; natural environment type (phobias storms, height, water ...); blood type - injection - accident (phobia of seeing blood or an accident or having an injection or any other invasive medical procedure); situational type (fear of specific situations such as public transport, tunnels, bridges, elevators, air travel, driving a car or enclosed areas); another type: afraid to choke, to vomit or contract an illness, fear of falling, and fears about loud noises or disguised characters.
- People accepting regular follow-up until one year after the first session.
Who cannot join
- Subject unable to read or/and write
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Phobias Using Emotional Regulation Developed by the Tipi Association
- Background In emotional regulation, the patient remembers an emotional situation, focuses his attention on his physical sensations when he relives a recent emotion, and let evolve his sensations.
- Method Evaluate the relevance of this method by an interventional study, in a pre-post mono group, on patients suffering from phobia.
- Objective The investigators aim to validate the effectiveness of this emotional regulation method and compare its results with that of conventional methods. Sessions are individual and repeated until the disappearance of phobic fear.
The present study may contribute to propose a new possibility to treat phobias in a simple and fast way.
Read the detailed description
Between 2003 and 2006, the investigators conducted an exploratory, prospective and comparative research study, taking each person as their own control, to evaluate the benefits of the type of emotional regulation developed by the Tipi association on a population suffering from phobias.
- Participants Phobias can be categorized by type, as defined in the DSM IV, the standard reference during the study period (American Psychiatriy Association, 2000) : agoraphobias, social phobias, specific situational phobias (claustrophobia, transport phobia), phobias linked to the natural environment (heights, water, fire), to animals (spiders, snakes, amphibians, tentacled shellfish) and other types of specific phobias (fear of physical contact, being dirtied, contaminated, vomiting), phobia of blood - injections - medical techniques - accidents.
The investigators aim to conduct a prior and systematic verification with each person to confirm that their fears were phobias as defined in the DSM IV (American Psychiatriy Association, 2000). The phobia must be diagnosed by a doctor or psychiatrist. Each people must provide a medical certificate that evidenced the diagnosis in writing.
All people must read an information form on "Understanding your emotions" All participants must have suffered from their phobias for a long time. They have to describe their treatment.
Everybody in the study population have to provide a short-written report on the effects of the session(s) 1 week, 1 month, 3 months and 12 months after the session.
- Intervention (see below)
- Follow-up During the one-year follow-up period, the patient was requested to send a written self-assessment of his situation and the change and/or disappearance of his phobia. If the investigators didn't receive the person's assessment, the investigators followed-up with a mail and a phone call.
- Conditions
- Phobic Fear
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of phobic fear
evolution of phobic fear
Measured: Assessment at 3 and 12 month after the first session
Secondary outcomes (4)
number of sessions needed for the disappearance of phobic fear
number of sessions needed for the disappearance of phobic fear
Measured: 1 day
adverse reaction rate and description
adverse reaction rate and description
Measured: 1 day
existence of physical and psychological sensations experienced during the sessions and just in the course of
existence of physical and psychological sensations experienced during the sessions and just in the course of
Measured: 1 day
degree of process acceptance for the patient
degree of process acceptance for the patient
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Jan 2003
- Primary completion1 Dec 2006
- Study completion30 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic FearStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Luc Nicon, Education Specialist, Founder of "Tipi", a non-profit French association
- Responsible party
- Sponsor
- Investigators
- Luc Nicon, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165954
- Sponsor's protocol ID
- RECHMPL19_0539
- Acronym
- RE
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Phobias Using Emotional Regulation Developed by the Tipi Association
- ClinicalTrials.gov ID
- NCT04165954
- Acronym / sponsor ID
- RE / RECHMPL19_0539
- Conditions
- Phobic Fear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Luc Nicon, Education Specialist, Founder of "Tipi", a non-profit French association
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Dec 2006 (actual)
- Study completion
- 30 Dec 2006 (actual)
- First posted
- 18 Nov 2019 (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.
- Background In emotional regulation, the patient remembers an emotional situation, focuses his attention on his physical sensations when he relives a recent emotion, and let evolve his sensations.
- Method Evaluate the relevance of this method by an interventional study, in a pre-post mono group, on patients suffering from phobia.
- Objective The investigators aim to validate the effectiveness of this emotional regulation method and compare its results with that of conventional methods. Sessions are individual and repeated until the disappearance of phobic fear.
The present study may contribute to propose a new possibility to treat phobias in a simple and fast way.
Detailed description
Between 2003 and 2006, the investigators conducted an exploratory, prospective and comparative research study, taking each person as their own control, to evaluate the benefits of the type of emotional regulation developed by the Tipi association on a population suffering from phobias.
- Participants Phobias can be categorized by type, as defined in the DSM IV, the standard reference during the study period (American Psychiatriy Association, 2000) : agoraphobias, social phobias, specific situational phobias (claustrophobia, transport phobia), phobias linked to the natural environment (heights, water, fire), to animals (spiders, snakes, amphibians, tentacled shellfish) and other types of specific phobias (fear of physical contact, being dirtied, contaminated, vomiting), phobia of blood - injections - medical techniques - accidents.
The investigators aim to conduct a prior and systematic verification with each person to confirm that their fears were phobias as defined in the DSM IV (American Psychiatriy Association, 2000). The phobia must be diagnosed by a doctor or psychiatrist. Each people must provide a medical certificate that evidenced the diagnosis in writing.
All people must read an information form on "Understanding your emotions" All participants must have suffered from their phobias for a long time. They have to describe their treatment.
Everybody in the study population have to provide a short-written report on the effects of the session(s) 1 week, 1 month, 3 months and 12 months after the session.
- Intervention (see below)
- Follow-up During the one-year follow-up period, the patient was requested to send a written self-assessment of his situation and the change and/or disappearance of his phobia. If the investigators didn't receive the person's assessment, the investigators followed-up with a mail and a phone call.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with a phobic fear listed in the DSM IV classification
Key inclusion criteria (4 listed)
- Adult: 18-90 years old
- Adult People with phobic fear in the DSM IV classification
- Phobic people: agoraphobia, with or without panic associated, social phobias and specific phobias. Diagnosis of phobias must be established by the medical world during consultations and explorations. This is systematically checked with the patient to see if the fears come under a phobia as defined in the DSM IV, reference at the time in 2006 (ref DSM IV). The list of phobias classified by type is as follows: animal type or insects; natural environment type (phobias storms, height, water ...); blood type - injection - accident (phobia of seeing blood or an accident or having an injection or any other invasive medical procedure); situational type (fear of specific situations such as public transport, tunnels, bridges, elevators, air travel, driving a car or enclosed areas); another type: afraid to choke, to vomit or contract an illness, fear of falling, and fears about loud noises or disguised characters.
- People accepting regular follow-up until one year after the first session.
Key exclusion criteria (1 listed)
- Subject unable to read or/and write
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evolution of phobic fear
Time frame: Assessment at 3 and 12 month after the first session
evolution of phobic fear
4 secondary outcomes
number of sessions needed for the disappearance of phobic fear
Time frame: 1 day
adverse reaction rate and description
Time frame: 1 day
existence of physical and psychological sensations experienced during the sessions and just in the course of
Time frame: 1 day
degree of process acceptance for the patient
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Luc Nicon principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phobic Fear, run by University Hospital, Montpellier at 1 site 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: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of phobic fear (time frame: Assessment at 3 and 12 month after the first session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019.