NCT07266376Not yet recruiting
Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS
Validation of a VOICE MAnagement Program in Schizophrenia
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 5 Jan 2026
- Primary completion date
- 5 Jan 2027
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Diseases
- Schizophrenia
- NCT number
- NCT07266376
What you commit to
- Study type: Interventional
- Planned participants: 116
- From 5 Jan 2026 to the primary completion date, 5 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another study: Currently taking part in another clinical trial or within the exclusion period of another study.
Other illness
- 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.
Other
- Patients will be excluded from the study if they meet any of the following criteria:
- Consent refusal: Refuse to sign the written informed consent.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Public Mental Health Institution of Guadeloupe Coordinator of this site? Confirm its status | Les Abymes | Guadeloupe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.