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Behavioral and Cognitive Therapies for Auditory Hallucination Management (AcceptVoice)

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ClinicalTrials.gov Identifier: NCT03348787
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
The present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Chronic Psychosis Behavioral: Behavioral and Cognitive Therapies Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Behavioral and Cognitive Therapies
Chronic psychotic patients will have Behavioral and Cognitive Therapies
Behavioral: Behavioral and Cognitive Therapies
Group intervention of 6 weekly sessions of one hour and 30 minutes based on the psychoeducational therapeutic principles and CBT type 3 wave "Accept Voices" applied to HAV



Primary Outcome Measures :
  1. intensity HAV symptoms [ Time Frame: Baseline and one week after the last session ]
    Difference between the Psychotic Symptom Rating Scales (PSYRATS) on HAV symptom score administered before the first therapeutic group session and the PSYRATS symptom score administered 1 week after the last group session. The PSYRATS Scales measure dimensions of hallucinations and delusions.


Secondary Outcome Measures :
  1. Effect over time [ Time Frame: Until 12 months after the last session ]
    Difference between the PSYRATS score given 1 week before the first session, and the PSYRATS score administered one week after the last session and then at 6 weeks, 6 months and 12 months.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenic disorders, schizo-affective disorders
  • Suffering from persistent HAV
  • No change in symptomatology for 3 months.
  • No anticipated change in antipsychotic treatment (anti-hallucinatory): olanzapine, risperidone, amisulpride, quetiapine, aripiprazole, loxapine, haloperidol, clopixol, modecate, nozinan, cyamemazine, piportil, clozapine
  • Major patient, or major incompetent.

Exclusion Criteria:

  • Mental retardation
  • Subject participating in another search including an exclusion period still in progress at pre-inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348787


Contacts
Contact: Axel Bourcier, MD 33-534557507 bourcier.a@chu-toulouse.fr
Contact: Thomas Langlois, Physcholog tomalanglois@hotmail.com

Locations
France
Lannemezan Hospital Recruiting
Lannemezan, France, 65300
Contact: Laila OSTENDORF         
Lavaur Hospital Recruiting
Lavaur, France, 81502
Contact: Maryse GUEGAN, MD         
Sainte-Marie de Rodez Hospital Recruiting
Rodez, France, 12032
Contact: Catalin BOTU, MD         
Ariège-Couserans Hospital Recruiting
Saint-Lizier, France, 09190
Contact: P GOINEAU, MD         
Gérard Marchand Hospital Recruiting
Toulouse, France, 31057
Contact: VERY Etienne, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Axel Bourcier, PhD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03348787     History of Changes
Other Study ID Numbers: RC31/17/0159
2017-A01929-44 ( Registry Identifier: French ANSM register )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Behavioral and Cognitive Therapies

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms