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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Peer delivered support intervention for people who hear voices: Pilot randomised controlled trial
Scientific title
Effect of a peer delivered support intervention for people who hear voices on subjective impact of voices
Secondary ID [1] 281093 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auditory verbal hallucinations 287248 0
Schizophrenia 287249 0
Psychotic disorders 287250 0
Condition category
Condition code
Mental Health 287573 287573 0 0

Study type
Description of intervention(s) / exposure
Participants will receive 12 weekly one hour one-to-one sessions of a support intervention for hearing voices (auditory verbal hallucinations) from a peer mental health worker who has had personal lived experience of hearing voices themselves. The intervention will involve buidling a shared understanding of the participant's experience of hearing voices and using this to inform how to respond to hearing voices and cope with this experience more effectively. The intervention group will receive the intervention alongside treatment as usual (TAU) in the 3 month period immediately following randomisation, whilst the control group will receive the intervention after a 3 month TAU wait list period.
Intervention code [1] 285545 0
Comparator / control treatment
Treatment as usual (wait list). The control group will receive the intervention after a 3 month treatment as usual wait list period. Treatment as usual will involve the person's usual mental health care which will oridinarily include prescription of antipsychotic medication, plus meetings with mental health workers and possible attendence at rehabilitative and recovery-oriented mental health service programmes. Participants in current receipt of formal psychological interventions will not be eligible to participate. Antipsychotic medication prescribing will be tracked in both conditions and chlorpromazine-equivalent dosages controlled for in analyses if needed.
Control group

Primary outcome [1] 287835 0
Subjective Experiences of Psychosis Scale
Timepoint [1] 287835 0
Baseline, 3 months (post-intervention), 6 months (follow-up)
Secondary outcome [1] 298901 0
Psychotic Symptom Rating Scales - Auditory Hallucinations
Timepoint [1] 298901 0
baseline, 3 months, 6 months
Secondary outcome [2] 298902 0
Recovery Assessment Scale
Timepoint [2] 298902 0
Baseline, 3 months, 6 months

Key inclusion criteria
Auditory verbal hallucinations at least weekly over the past six months associated with significant distress or disability
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Recent (past 8 weeks) or planned change in antipsychotic medication
Currently receiving individual psychological therapy
Insufficient English or intellectual functioning to meaningfully participate

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

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5735 0
Recruitment postcode(s) [2] 5736 0
Recruitment postcode(s) [3] 5737 0

Funding & Sponsors
Funding source category [1] 285880 0
Name [1] 285880 0
John T Reid Charitable Trust
Address [1] 285880 0
PO Box 438
Canterbury VIC 3128
Country [1] 285880 0
Primary sponsor type
Monash Alfred Psychiatry Research Centre
The Alfred
Commercial Road
Melbourne VIC 3004
Secondary sponsor category [1] 284705 0
Name [1] 284705 0
Prahran Mission
Address [1] 284705 0
Chapel Street
PO Box 68
Prahran VIC 3181
Country [1] 284705 0

Ethics approval
Ethics application status
Ethics committee name [1] 287907 0
Alfred HREC
Ethics committee address [1] 287907 0
Office of Research and Governance
The Alfred
Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 287907 0
Date submitted for ethics approval [1] 287907 0
Approval date [1] 287907 0
Ethics approval number [1] 287907 0

Brief summary
Hearing voices (auditory verbal hallucination) is a potentially distressing and disabling experience which often persists in spite of treatment with medication. This pilot study examines whether it is helpful for people who hear voices to receive assistance in coping with this experience from someone else who hears voices and has adapted to living with this experience.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34619 0
Address 34619 0
Country 34619 0
Phone 34619 0
Fax 34619 0
Email 34619 0
Contact person for public queries
Name 17866 0
Ms Indigo Daya
Address 17866 0
Voices Vic
15 Cromwell Road
South Yarra VIC 3141
Country 17866 0
Phone 17866 0
+61 3 9692 9562
Fax 17866 0
Email 17866 0
Contact person for scientific queries
Name 8794 0
Dr Neil Thomas
Address 8794 0
Monash Alfred Psychiatry Research Centre
Level 3, 607 St Kilda Road
Melbourne VIC 3004
Country 8794 0
Phone 8794 0
+61 3 9076 6564
Fax 8794 0
Email 8794 0

No information has been provided regarding IPD availability
Summary results
No Results