Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS (NCT07266376) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS
Guadeloupe116 participantsStarted 2026-01-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs)
Timeframe: Baseline (before the intervention, D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
Trial details
NCT IDNCT07266376
SponsorCentre Hospitalier Universitaire de la Guadeloupe