Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS

NCT ID: NCT07266376

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2027-01-05

Brief Summary

Approximately 25-50% of patients with schizophrenia experience treatment-resistant Auditory Verbal Hallucinations (AVHs), which contribute to the development of associated psychopathological disorders (e.g., anxiety, depression, suicidal ideation). Various validated psychotherapeutic strategies and tools for managing treatment-resistant AVHs have been combined into an integrative therapeutic program. The main objective of this study is to evaluate the efficacy of this program in reducing the frequency and intensity of AVHs, as well as its impact on comorbid psychopathology (e.g., depression, anxiety, self-esteem, substance use) in patients with schizophrenia or schizoaffective disorder who experience treatment-resistant AVHs.

Detailed Description

The present study is a multicenter, prospective, randomized trial with two groups. Its main objective is to evaluate the efficacy of an integrative group therapy for drug-resistant Auditory Verbal Hallucinations (AVHs) in patients with schizophrenia or schizoaffective disorder. A total of 114 patients will be randomly assigned to the experimental or control group. The experimental group will receive integrative therapy sessions, while the control group will participate in an audio-visual group reflecting usual care.

Both experimental and control groups will attend fifteen weekly 1.5-hour sessions, supervised by a psychologist and a nurse trained in, or at least familiar with, cognitive-behavioral therapy. The sessions for the experimental group are organized as follows:

Sessions 1-2: Psychoeducation about AVHs Sessions 3-6: Metacognitive training Sessions 7-9: Monitoring voices using a notebook Session 10: Gaining control over voices through attentional distraction Session 11: Voice avatar creation Sessions 12-13: Dialogue with voices Session 14: Compassion-based mindfulness Session 15: Living with voices and community integration

Conditions

Mental Disorder; Schizophrenia Diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Media-workshop control group

Patients randomly assigned to the media-workshop control group will participate in 15 weekly sessions (1.5 hour per session) consisting in commenting two short episodes from the series "Malcolm in the middle". This early 2000 TV show exposes the daily life of a low middle class American family. The purpose is to focus on social cognition through the reading of intentions, identification of clues supporting any hypotheses, discuss these hypotheses or even identify alternative hypotheses.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Psychoeducation & Metacognitive Training

Experimental group sessions are organized as follow : Psychoeducation of AVHs (sessions 1 and 2); Metacognitive training (sessions 3 to 6); Paying attention to voices through the use of a notebook (sessions 7 to 9); Taking control over the voices through - Attentional Distraction (session 10); Voice avatar creation (session 11); Dialogue with voices (sessions 12 \& 13); Compassion-based mindfulness (session 14); Living with voices and community integration (session 15).

Group Type: EXPERIMENTAL

Integrative group therapy

Intervention Type: BEHAVIORAL

Integrative group therapy includes 15 sessions weekly, 1.5 hours sessions supervised by one psychologist and one nurse, trained in or at least familiar with cognitive-behavioural therapy.

Interventions

Integrative group therapy

Integrative group therapy includes 15 sessions weekly, 1.5 hours sessions supervised by one psychologist and one nurse, trained in or at least familiar with cognitive-behavioural therapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Consenting patients over 18 years of age will be enrolled in the study if they meet all of the following criteria:

• Diagnosis: Fulfill DSM-5 criteria for schizophrenia or schizoaffective disorder.
• Resistant AVHs: Present treatment-resistant auditory verbal hallucinations (AVHs), defined as the persistence of daily hallucinations without remission despite adequate antipsychotic medication for at least 3 months.
• Motivation: Express a request for relief from voices.
• Treatment Setting: Are outpatients being treated in psychiatric departments at the Public Mental Health Institution of Guadeloupe or the University Hospital Center of Nîmes.
• Severity: Have a score of greater than 9 on the Psychotic Symptom Rating Scale - Auditory Hallucinations subscale (PSYRATS-AH).

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:

• Participation in another study: Currently taking part in another clinical trial or within the exclusion period of another study.
• Consent refusal: Refuse to sign the written informed consent.
• Inability to provide informed consent: Failure or impossibility to provide the patient with sufficient information to allow an informed decision.
• Severe substance abuse: Presence of severe substance use disorder.
• Acute somatic decompensation: Experiencing an acute medical condition that may compromise participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GIRCI SOHO

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabrina Jumentier, PhD

Role: STUDY_DIRECTOR

Public Mental Health Institution of Guadeloupe

Locations

Public Mental Health Institution of Guadeloupe

Les Abymes, , Guadeloupe

Countries

Guadeloupe

Central Contacts

melanie petapermal, MD

Role: CONTACT

melanie.petapermal@chu-guadeloupe.fr

+590590934667

Valérie Hamony Soter

Role: CONTACT

valerie.soter@chu-guadeloupe.fr

+590590934677

Facility Contacts

Sabrina Jumentier, PhD

Role: primary

sabrina.jumentier@epsm-guadeloupe.fr

+33679342982

Jumentier

Role: backup

Other Identifiers

PAP_RI2_2021/16

Identifier Type: -

Identifier Source: org_study_id