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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05982158




Registration number
NCT05982158
Ethics application status
Date submitted
20/07/2023
Date registered
8/08/2023

Titles & IDs
Public title
Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices
Scientific title
Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial
Secondary ID [1] 0 0
GNT2015133
Universal Trial Number (UTN)
Trial acronym
AMETHYST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auditory Hallucination 0 0
Psychotic Disorders 0 0
Schizophrenia and Related Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Avatar therapy
BEHAVIORAL - Cognitive behavioural therapy (CBT)

Active comparator: 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.

Experimental: 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.


BEHAVIORAL: Avatar therapy
Seven 50-minute therapy sessions conducted by videoconferencing.

BEHAVIORAL: Cognitive behavioural therapy (CBT)
Seven 50-minute therapy sessions conducted by videoconferencing.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS)
Timepoint [1] 0 0
Immediately post intervention (3 months), controlling for baseline
Secondary outcome [1] 0 0
Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups
Timepoint [1] 0 0
Baseline, follow-ups (6 and 9 months)
Secondary outcome [2] 0 0
Change in auditory verbal hallucination-related distress, measured by the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) Distress Score
Timepoint [2] 0 0
Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months)
Secondary outcome [3] 0 0
Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS)
Timepoint [3] 0 0
Immediately post intervention (3 months), follow-ups (6 and 9 months)
Secondary outcome [4] 0 0
Change in overall psychosis symptom severity, measured by Positive and Negative Syndrome Scales (PANSS) total and sub scale scores
Timepoint [4] 0 0
Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
Secondary outcome [5] 0 0
Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS)
Timepoint [5] 0 0
Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
Secondary outcome [6] 0 0
Change in anxiety symptoms, measured by the anxiety scale of the 21-item Depression Anxiety Stress Scale (DASS-21)
Timepoint [6] 0 0
Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
Secondary outcome [7] 0 0
Personal recovery (consumer-defined recovery), measured by the Questionnaire for the Process of Recovery (QPR)
Timepoint [7] 0 0
Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Copenhagen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Manchester
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Melbourne
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Perth Voices Clinic
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of the Sunshine Coast
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Toronto
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil Thomas
Address 0 0
Swinburne University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Neil Thomas
Address 0 0
Country 0 0
Phone 0 0
+61 3 92148742
Fax 0 0
Email 0 0
neilthomas@swin.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05982158