Validation of a VOICE MAnagement Program in Schizophrenia VVoice MAPS

Официальное название

Validation of a VOICE MAnagement Program in Schizophrenia

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs) [Срок оценки: Baseline (before the intervention, D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).]

Вторичные конечные точки (6)

• Belief and Trust in AVHs [Срок оценки: 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 [Срок оценки: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).]
• Depression [Срок оценки: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).]
• Self-Esteem [Срок оценки: 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 [Срок оценки: Baseline (D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).]
• Exploratory Outcome: Substance Use [Срок оценки: Baseline (D1 - before intervention); One month after the end of the intervention (D2); Six months after the end of the intervention (D3)]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Guadeloupe · 1 центр

• Public Mental Health Institution of Guadeloupe — Les Abymes

Идентификаторы

NCT: NCT07266376 · PAP_RI2_2021/16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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