NCT03348787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

November 14, 2017

Last Update Submit

July 29, 2020

Conditions

Keywords

Behavioral and Cognitive Therapies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effect over time

    Until 12 months after the last session

Study Arms (1)

Behavioral and Cognitive Therapies

EXPERIMENTAL

Chronic psychotic patients will have Behavioral and Cognitive Therapies

Behavioral: Behavioral and Cognitive Therapies

Interventions

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

Behavioral and Cognitive Therapies

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lannemezan Hospital

Lannemezan, 65300, France

Location

Lavaur Hospital

Lavaur, 81502, France

Location

Sainte-Marie de Rodez Hospital

Rodez, 12032, France

Location

Ariège-Couserans Hospital

Saint-Lizier, 09190, France

Location

Gérard Marchand Hospital

Toulouse, 31057, France

Location

MeSH Terms

Conditions

Behavior

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Axel Bourcier, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 21, 2017

Study Start

December 13, 2017

Primary Completion

December 5, 2019

Study Completion

June 30, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations