Validation of a VOICE MAnagement Program in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessments will be conducted by a trained professional, blinded to the intervention group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Media-workshop control group
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 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).
干预措施: Integrative group therapy (Behavioral)
结局指标
主要结局
Change in Phenomenological Features of Auditory Verbal Hallucinations (AVHs)
时间窗: Baseline (before the intervention, D1), one month after the end of the intervention (D2), and six months after the end of the intervention (D3).
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.
次要结局
- 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).)
- Exploratory Outcome: Substance Use(Baseline (D1 - before intervention); One month after the end of the intervention (D2); Six months after the end of the intervention (D3))