Clinical trial NCT05982158: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Auditory Hallucination
Psychotic Disorders
Schizophrenia and Related Disorders
Keywords: Auditory verbal hallucinations
Psychosis
Schizophrenia
Psychological therapy
Cognitive behavior therapy
Avatar therapy
Virtual reality
Telehealth
Lead sponsor: Swinburne University of Technology
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of Manchester
name: University of Melbourne
name: Monash University
name: Perth Voices Clinic
name: University of the Sunshine Coast
name: University of Toronto
First posted: 2023-08-08
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AMETHYST is a pragmatic, parallel group, randomised controlled superiority trial, comparing avatar therapy to CBT for persisting AVHs, with the primary outcome of post-intervention hallucination severity. In both arms, therapy will be delivered within a three-month period, with assessor-blinded assessments completed at baseline, post-intervention (3 months), and follow-ups (6 months and 9 months).
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS)
timeFrame: Immediately post intervention (3 months), controlling for baseline
Secondary outcomes:
measure: Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups
timeFrame: Baseline, follow-ups (6 and 9 months)
measure: Change in auditory verbal hallucination-related distress, measured by the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) Distress Score
timeFrame: Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months)
measure: Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS)
timeFrame: Immediately post intervention (3 months), follow-ups (6 and 9 months)
measure: Change in overall psychosis symptom severity, measured by Positive and Negative Syndrome Scales (PANSS) total and sub scale scores
timeFrame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
measure: Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
measure: Change in anxiety symptoms, measured by the anxiety scale of the 21-item Depression Anxiety Stress Scale (DASS-21)
timeFrame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
measure: Personal recovery (consumer-defined recovery), measured by the Questionnaire for the Process of Recovery (QPR)
timeFrame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
Other outcomes:
measure: Satisfaction with therapy, measured by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Immediatedly post-intervention (3 months)
measure: Adverse effects of therapy
timeFrame: Immediately post-intervention (3 months)
measure: Cost-effectiveness
timeFrame: Immediately post intervention (3 months), follow-ups (6 and 9 months)
measure: Change in the impact of AVHs, measured by the Voice Impact Scale (VIS)
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in AVH content, measured by the Voice Content Questionnaire (VCQ)
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in attention paid to AVHs, measured by the Listening and Believing Assessment for Voices
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in confidence in coping with AVHs - single item rating
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in interpersonal appraisals of AVHs, measured by the Beliefs About Voices Scale (BAVQ-R)
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in interpersonal appraisals of AVHs, measured by the Voice Power Differential Scale (VPDS)
timeFrame: [Time Frame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)]
measure: Change in interpersonal responses to AVHs, measured by the APPROVE
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in flexibility in interpersonal reponse to AVHs, measured by the Circumplex Scales for Interpersonal Efficacy (CSIE)
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
measure: Change in positive and negative views of self and others, measured by the Brief Core Schema Scales (BCSS)
timeFrame: Baseline, immediately post-intervention (3 months), follow-ups (6 and 9 months)
Locations:
city: Hawthorn
country: Australia
facility: Swinburne University of Technology
state: Victoria
Study officials:
affiliation: Swinburne University of Technology
name: Neil Thomas
role: PRINCIPAL_INVESTIGATOR
References: