Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS)
研究概览
简要总结
The aim of this study is to compare the effects of a new psychological therapy, Avatar Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving outcomes in people living with psychotic disorders who have persisting experiences of hearing voices (auditory verbal hallucinations, AVHs).
详细描述
Continually hearing critical, abusive or threatening voices (auditory verbal hallucinations, AVHs) is a major persisting and disabling symptom of psychotic disorders such as schizophrenia. Current treatments have universally had only modest impact. In preliminary trials, a brief digitally supported treatment, using avatars to recreate AVHs during therapy, has produced some of the largest reductions in AVH severity seen to date. To definitively test the superiority of this innovative treatment, AMETHYST is a randomised controlled trial comparing avatar therapy to current recommended best practice treatment, CBT, for medication-resistant AVHs.
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
Outcomes assessors involved in completing the assessments will be masked to treatment condition. Due to the type of intervention, it will not be possible to blind therapists delivering the interventions to participant's treatment condition. Clinicians providing routine care will also be aware of the condition. Participants will be instructed not to discuss treatment with their outcomes assessor. When an interview leads to unblinding, the outcomes assessor will be replaced.
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
- •Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis confirmed using the Structured Clinical Interview for DSM (SCID)
- •Experiencing current auditory verbal hallucinations as measured by the Positive and Negative Syndrome Scale (PANSS) item P3 ≥ 4
- •Auditory verbal hallucinations present for at least one year
- •AVHs include significant negative content (PSYRATS item 6 ≥ 2) and/or AVHs are distressing (PSYRATS item item 9 ≥ 2)
- •Current treatment with antipsychotic medication, or has been treated with antipsychotic medication in the past, with at least two different antipsychotic compounds, and these have been discontinued due to insufficient treatment response and/or poor tolerability.
- •Access to the internet and a computer or other device on which videoconferencing software can be used
- •Sufficient fluency in English for meaningful participation
- •Age 18 or over
- •Ability to give informed consent
排除标准
- •Auditory verbal hallucinations attributable to a primary substance use disorder or organic disorder
- •Estimated full scale IQ < 70 (using the Test of Premorbid Functioning, TOPF)
- •Within the last month or planned at the time of intake: a change of antipsychotic medication,
- •Current or within the past 3 months receipt of individual psychological therapy for hearing voices, or receipt of electro-convulsive therapy or other brain stimulation treatment;
- •AVHs in a language not spoken by the therapists.
结局指标
主要结局
Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS)
时间窗: Immediately post intervention (3 months), controlling for baseline
Clinician-rated scale providing an index of overall severity based on 11 aspects of hallucinations (frequency, duration, intensity of distress, etc.), rated masked to treatment allocation. Each of the 11-items are scored on a 5-point scale (0 - 4), scores range from 0 to 44, with increased symptom expression indicated by higher scores.
次要结局
- Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS)(Immediately post intervention (3 months), follow-ups (6 and 9 months))
- Change in anxiety symptoms, measured by the anxiety scale of the 21-item Depression Anxiety Stress Scale (DASS-21)(Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months))
- Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups(Baseline, follow-ups (6 and 9 months))
- Personal recovery (consumer-defined recovery), measured by the Questionnaire for the Process of Recovery (QPR)(Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months))
- Change in auditory verbal hallucination-related distress, measured by the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) Distress Score(Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months))
- Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS)(Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months))
- Change in overall psychosis symptom severity, measured by Positive and Negative Syndrome Scales (PANSS) total and sub scale scores(Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months))