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

Official title

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

Overview

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).

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Australia · 1 center

• Swinburne University of Technology — Hawthorn

Identifiers

NCT: NCT05982158 · GNT2015133

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗