Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de la Guadeloupe
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Integrative group therapy
BehavioralIntegrative 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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Media-workshop control groupNo intervention 0 interventions
Group B: Psychoeducation & Metacognitive TrainingExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
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
1
Belief and Trust in AVHs
Belief and Trust in Auditory Verbal Hallucinations (AVHs) Beliefs about and trust in AVHs will be assessed using the Beliefs About Voices Questionnaire-Revised (BAVQ-R). The BAVQ-R evaluates participants' beliefs, emotional responses, and behavioral engagement with voices. Each item is rated on a 0-4 Likert scale, with a total score range of 0 to 56, where higher scores indicate stronger beliefs in, or greater trust toward, the voices. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased evaluation.
Time frame
Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).2
Attitudes and Reactions Towards AVHs
Attitudes and Reactions Towards Auditory Verbal Hallucinations (AVHs) Attitudes toward and behavioral reactions to AVHs will be assessed using the Voice Attitude and Action Scale - 9 items (VAAS-9). Each item is rated on a 0-4 Likert scale, resulting in a total score range of 0 to 36, where higher scores indicate more adaptive attitudes and actions toward voices. All assessments will be performed by an investigator blinded to group assignment to ensure unbiased measurement.
Time frame
Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).3
Depression
Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS). The CDSS consists of 9 items, each scored on a 0-3 scale, resulting in a total score range of 0 to 27, where higher scores indicate more severe depressive symptoms. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased evaluation.
Time frame
Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).4
Self-Esteem
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES). The scale includes 10 items, each rated on a 0-3 Likert scale, resulting in a total score range of 0 to 30, where higher scores indicate higher self-esteem. All assessments will be conducted by an investigator blinded to group assignment to ensure unbiased measurement.
Time frame
Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).Sponsors and contacts
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Centre Hospitalier Universitaire de la Guadeloupe
Lead sponsor
GIRCI SOHO
Collaborator
Source ClinicalTrials.gov
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