- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348787
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
-
-
-
Lannemezan, France, 65300
- Lannemezan Hospital
-
Lavaur, France, 81502
- Lavaur Hospital
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Rodez, France, 12032
- Sainte-Marie de Rodez Hospital
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Saint-Lizier, France, 09190
- Ariège-Couserans Hospital
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Toulouse, France, 31057
- Gérard Marchand Hospital
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-
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
|
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
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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