Behavioral and Cognitive Therapies for Auditory Hallucination Management (AcceptVoice)

July 29, 2020 updated by: University Hospital, Toulouse

Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lannemezan, France, 65300
        • Lannemezan Hospital
      • Lavaur, France, 81502
        • Lavaur Hospital
      • Rodez, France, 12032
        • Sainte-Marie de Rodez Hospital
      • Saint-Lizier, France, 09190
        • Ariège-Couserans Hospital
      • Toulouse, France, 31057
        • Gérard Marchand Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and one week after the last session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until 12 months after the last session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Axel Bourcier, PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2017

Primary Completion (Actual)

December 5, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/17/0159
  • 2017-A01929-44 (Registry Identifier: French ANSM register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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