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Behavioral and Cognitive Therapies for Auditory Hallucination Management (AcceptVoice)

Primary Purpose

Chronic Psychosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Behavioral and Cognitive Therapies
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Psychosis focused on measuring Behavioral and Cognitive Therapies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lannemezan Hospital
  • Lavaur Hospital
  • Sainte-Marie de Rodez Hospital
  • Ariège-Couserans Hospital
  • Gérard Marchand Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral and Cognitive Therapies

Arm Description

Chronic psychotic patients will have Behavioral and Cognitive Therapies

Outcomes

Primary Outcome Measures

intensity HAV symptoms
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

Effect over time
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.

Full Information

First Posted
November 14, 2017
Last Updated
July 29, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03348787
Brief Title
Behavioral and Cognitive Therapies for Auditory Hallucination Management
Acronym
AcceptVoice
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Psychosis
Keywords
Behavioral and Cognitive Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral and Cognitive Therapies
Arm Type
Experimental
Arm Description
Chronic psychotic patients will have Behavioral and Cognitive Therapies
Intervention Type
Behavioral
Intervention Name(s)
Behavioral and Cognitive Therapies
Intervention Description
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 Measure Information:
Title
intensity HAV symptoms
Description
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.
Time Frame
Baseline and one week after the last session
Secondary Outcome Measure Information:
Title
Effect over time
Description
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.
Time Frame
Until 12 months after the last session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Bourcier, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lannemezan Hospital
City
Lannemezan
ZIP/Postal Code
65300
Country
France
Facility Name
Lavaur Hospital
City
Lavaur
ZIP/Postal Code
81502
Country
France
Facility Name
Sainte-Marie de Rodez Hospital
City
Rodez
ZIP/Postal Code
12032
Country
France
Facility Name
Ariège-Couserans Hospital
City
Saint-Lizier
ZIP/Postal Code
09190
Country
France
Facility Name
Gérard Marchand Hospital
City
Toulouse
ZIP/Postal Code
31057
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Behavioral and Cognitive Therapies for Auditory Hallucination Management

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