Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000974808
Ethics application status
Approved
Date submitted
25/08/2012
Date registered
10/09/2012
Date last updated
10/09/2012
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
Nil
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
Schizophrenia

Intervention/exposure
Study type
Interventional
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
Behaviour
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5735 0
3004
Recruitment postcode(s) [2] 5736 0
3141
Recruitment postcode(s) [3] 5737 0
3181

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

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 287907 0
27/08/2012
Approval date [1] 287907 0
Ethics approval number [1] 287907 0

Summary
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

Contacts
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
Australia
Phone 17866 0
+61 3 9692 9562
Fax 17866 0
Email 17866 0
[email protected]
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
Australia
Phone 8794 0
+61 3 9076 6564
Fax 8794 0
Email 8794 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.