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

NCT ID: NCT05982158

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Auditory Hallucination Psychotic Disorders Schizophrenia and Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Cognitive Behavioural Therapy (CBT)

The standard therapy arm will be based on a focused cognitive behavioural therapy (CBT) protocol for AVHs. Sessions will involve discussing the characteristics of participant's AVHs, before applying core CBT approaches, adapted to the AVH experience, to conduct a thorough cognitive behavioural assessment with a focus on coping strategy enhancement and cognitive restructuring.

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy (CBT)

Intervention Type BEHAVIORAL

Seven 50-minute therapy sessions conducted by videoconferencing.

Avatar Therapy

The experimental arm will use avatar therapy. Sessions will involve generating an audio-visual avatar as a virtual representation of the primary 'voice' that the participant hears. This will be used to recreate AVHs experientially and allow participants to practice alternative ways of responding to the 'voice'. This innovative approach will be combined with the use of broader CBT methods.

Group Type EXPERIMENTAL

Avatar therapy

Intervention Type BEHAVIORAL

Seven 50-minute therapy sessions conducted by videoconferencing.

Interventions

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Avatar therapy

Seven 50-minute therapy sessions conducted by videoconferencing.

Intervention Type BEHAVIORAL

Cognitive behavioural therapy (CBT)

Seven 50-minute therapy sessions conducted by videoconferencing.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

Perth Voices Clinic

UNKNOWN

Sponsor Role collaborator

University of the Sunshine Coast

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Swinburne University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Thomas

Role: PRINCIPAL_INVESTIGATOR

Swinburne University of Technology

Locations

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Swinburne University of Technology

Hawthorn, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Neil Thomas

Role: CONTACT

+61 3 92148742

Leila Jameel, PhD, D Clin Psy

Role: CONTACT

+61 03 9214 4365

Facility Contacts

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Leila Jameel, PhD

Role: primary

61392144365

Other Identifiers

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GNT2015133

Identifier Type: -

Identifier Source: org_study_id

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