Behavioral and Cognitive Therapies for Auditory Hallucination Management

Chronic Psychosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348787
• Other study ID #: RC31/17/0159
• Secondary ID: 2017-A01929-44
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Psychosis
• Hallucinations
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
France	Lannemezan Hospital	Lannemezan
France	Lavaur Hospital	Lavaur
France	Sainte-Marie de Rodez Hospital	Rodez
France	Ariège-Couserans Hospital	Saint-Lizier
France	Gérard Marchand Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and one week after the last session
Secondary	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.	Until 12 months after the last session