RE: Treating Phobia by a New Emotional Regulation Method (Tipi)

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04165954
Collaborator
Luc Nicon, Education Specialist, Founder of "Tipi", a non-profit French association (Other)
170
1
47.9
3.5

Study Details

Study Description

Brief 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.

  • 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    170 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Treating Phobias Using Emotional Regulation Developed by the Tipi Association
    Actual Study Start Date :
    Jan 1, 2003
    Actual Primary Completion Date :
    Dec 1, 2006
    Actual Study Completion Date :
    Dec 30, 2006

    Outcome Measures

    Primary Outcome Measures

    1. evolution of phobic fear [Assessment at 3 and 12 month after the first session]

      evolution of phobic fear

    Secondary Outcome Measures

    1. number of sessions needed for the disappearance of phobic fear [1 day]

      number of sessions needed for the disappearance of phobic fear

    2. adverse reaction rate and description [1 day]

      adverse reaction rate and description

    3. existence of physical and psychological sensations experienced during the sessions and just in the course of [1 day]

      existence of physical and psychological sensations experienced during the sessions and just in the course of

    4. degree of process acceptance for the patient [1 day]

      degree of process acceptance for the patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria :
    • 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.

    Exclusion criteria:

    Subject unable to read or/and write

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier
    • Luc Nicon, Education Specialist, Founder of "Tipi", a non-profit French association

    Investigators

    • Principal Investigator: Luc Nicon, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04165954
    Other Study ID Numbers:
    • RECHMPL19_0539
    First Posted:
    Nov 18, 2019
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 19, 2019