Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices

Официальное название

Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое Avatar therapy
  Seven 50-minute therapy sessions conducted by videoconferencing.
• Поведенческое Cognitive behavioural therapy (CBT)
  Seven 50-minute therapy sessions conducted by videoconferencing.

Первичные конечные точки

• Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) [Срок оценки: Immediately post intervention (3 months), controlling for baseline]

Вторичные конечные точки (7)

• Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups [Срок оценки: Baseline, 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 [Срок оценки: Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months)]
• Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS) [Срок оценки: 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 [Срок оценки: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)]
• Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS) [Срок оценки: Baseline, 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) [Срок оценки: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)]
• Personal recovery (consumer-defined recovery), measured by the Questionnaire for the Process of Recovery (QPR) [Срок оценки: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

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

Австралия · 1 центр

• Swinburne University of Technology — Hawthorn

Идентификаторы

NCT: NCT05982158 · GNT2015133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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