Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS

NCT07266376 | Not Yet Recruiting

• 1 other identifier: PAP_RI2_2021/16
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder; Schizophrenia Diagnosis

Keywords

Schizophrenia; Auditory Verbal Hallucinations; Groupal Intervention; Integrative Approach

Outcome Measures

Primary Outcomes (1)

• Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs)

  Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs) Changes in the severity, intensity, frequency, and associated distress of AVHs will be assessed using the Psychotic Symptom Rating Scale - Auditory Hallucinations subscale (PSYRATS-AH). The PSYRATS-AH includes 11 items, each rated on a 0-4 Likert scale (total score range: 0 to 44), where higher scores indicate more severe hallucination-related symptomatology. All evaluations will be performed by an investigator blinded to group allocation to ensure unbiased assessment of treatment effects.

  Baseline (before the intervention, D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).

Secondary Outcomes (6)

• Belief and Trust in AVHs

  Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).

• Attitudes and Reactions Towards AVHs

  Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).

• Depression

  Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).

• Self-Esteem

  Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).

• Subjective Quality of Life

  Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).

Study Arms (2)

Media-workshop control group

NO INTERVENTION

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.

Psychoeducation & Metacognitive Training

EXPERIMENTAL

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).

Behavioral: Integrative group therapy

Interventions

Integrative group therapy 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.

Psychoeducation & Metacognitive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead
• GIRCI SOHO: collaborator

Study Sites (1)

Public Mental Health Institution of Guadeloupe

Les Abymes, 97139, Guadeloupe

Location

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabrina Jumentier, PhD

  Public Mental Health Institution of Guadeloupe

  STUDY DIRECTOR

Central Study Contacts

melanie petapermal, MD

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Valérie Hamony Soter

CONTACT

+590590934677; valerie.soter@chu-guadeloupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by a trained professional, blinded to the intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomly assigned to the media-workshop control group will participate in 15 weekly sessions (1.5 hours each), which consist of commenting on two short episodes of the TV series Malcolm in the Middle. This early-2000s show depicts the daily life of a lower-middle-class American family. The purpose of the sessions is to enhance social cognition by practicing the reading of intentions, identifying clues supporting hypotheses, discussing these hypotheses, and considering alternative explanations.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): January 5, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

GU (1)