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Trial registered on ANZCTR


Registration number
ACTRN12612000512820
Ethics application status
Approved
Date submitted
5/05/2012
Date registered
14/05/2012
Date last updated
14/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot safety and acceptability trial of moderated on-line social therapy (MOST) for first-episode psychosis.
Scientific title
A pilot safety and acceptability trial of moderated on-line social therapy (MOST) for first-episode psychosis.
Secondary ID [1] 280121 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First Episode Psychosis 286041 0
Condition category
Condition code
Mental Health 286232 286232 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our newly developed moderated on-line social therapy model (MOST) offers an ICT paradigm which has the potential to address important challenges in the engagement and treatment of young people recovering from early psychosis. We have pioneered and developed a new model for on-line behavioural interventions entitled “Moderated on-line social therapy” (MOST). The MOST model integrates on-line social networking with individually tailored interactive psychosocial interventions, with the involvement of expert mental health and peer moderators to ensure the effectiveness and safety of the intervention. MOST has been applied to a world-first program entitled “Horyzons” designed for the purpose of assisting young FEP patients in their recovery. Horyzons is a wesbite which has been designed as a supplement to traditional face-to-face biopsychosocial interventions for FEP, and has not been designed as a replacement for recommended treatments. The online intervention will be provided for a 4-week period. Participants will be asked to use Horyzons at their discretion.
Intervention code [1] 284453 0
Behaviour
Intervention code [2] 284848 0
Treatment: Other
Comparator / control treatment
Uncontrolled: the same intervention will be applied to all participants in the study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286708 0
Acceptability of the system will be considered achieved if 10 of the 20 participants log on more than once per week across each of the four weeks during the 1-month of the pilot.
Timepoint [1] 286708 0
Follow-up assessment post-trial (1 month follow-up)
Primary outcome [2] 286709 0
The pilot will be considered to indicate safety of the Horyzons system if: (i) all participants report feeling adequately supported by moderators via the semi-structured interview, (ii) two or less participants experience relapse in psychosis during the 1 month of the pilot; (iii) no participants deliberately self harm during the course of the pilot; and (iii) if there are no unlawful entries into the Horyzons system.
Timepoint [2] 286709 0
Follow-up assessment post-trial (1 month follow-up)
Secondary outcome [1] 296507 0
Nil
Timepoint [1] 296507 0
Nil

Eligibility
Key inclusion criteria
(a) a first episode of a DSM-IV psychotic disorder or mood disorder with psychotic features; (b) aged 15-25 years inclusive; (c) less than or equal to 6 months treatment with an antipsychotic medication prior to registration with the early psychosis service; (d) remission on positive symptoms of psychosis which will be defined as 4 weeks or more of scores of 3 (mild) or below on the subscale items hallucinations, unusual thought disorder, conceptual disorganization, and suspiciousness on the expanded version of the Brief Psychiatric Rating Scale (BPRS). Additional inclusion criteria to ensure low level of risk within MOST include: (e) low aggressiveness which will be defined by a score of 5 or below (with the exception of evidence of threat to others) on the hostility subscale of the expanded version of the BPRS for the month prior to study entry; and, (f) low suicidal risk defined as a score of 4 or below on the suicidality subscale for the month preceding study entry.
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) intellectual disability; (b) inability to converse in, or read English; (c) participation in previous CBT or pharmacological trials for psychosis; (d) a DSM-IV diagnosis of either antisocial personality disorder (ASPD) or borderline personality disorder (BPD); (e) pregnancy; (f) medical conditions requiring high level of care; (g) presence of acute psychotic symptoms above a mild level; (h) presence of moderate or above levels of suicidality or hostility.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After providing informed consent participants the RA will administer the SCID, BPRS and Calgary Depression Rating Scale. In a separate meeting the moderator will then orient participants to the Horyzons system. There will not be a control comparison intervention and all participants will have full access to their usual array of treatments at EPPIC and any treatments they are accessing elsewhere.
Participants will then be able to participate in Horzons at their convenience over a period of 1 month if they meet the inclusion and exclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284882 0
Charities/Societies/Foundations
Name [1] 284882 0
Telstra Foundation
Address [1] 284882 0
Locked Bag 5680
Melbourne VIC 3001
Country [1] 284882 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Helen Macpherson Smith Trust
Address
Helen Macpherson Smith Trust 27 Windsor Place
Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 283761 0
University
Name [1] 283761 0
Melbourne University, IBES
Address [1] 283761 0
Level 5, Alan Gilbert Blding,
161 Barry St (Cnr Grattan St),
3010 Carlton
Victoria
Country [1] 283761 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286877 0
Melbourne Health - Human Research and Ethics Commitee
Ethics committee address [1] 286877 0
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 286877 0
Australia
Date submitted for ethics approval [1] 286877 0
19/12/2011
Approval date [1] 286877 0
24/01/2012
Ethics approval number [1] 286877 0
2011.231

Summary
Brief summary
In this study we will evaluate the acceptability, feasibility, safety and initial clinical benefits of an online intervention (HORYZONS) designed to maintain the benefits of early intervention services for psychosis over the long term.
We expect that HORYZONS will be well-received, safe and seen as a valuable treatment option by young people suffering from psychosis.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33905 0
Address 33905 0
Country 33905 0
Phone 33905 0
Fax 33905 0
Email 33905 0
Contact person for public queries
Name 17152 0
Mario Alvarez
Address 17152 0
Orygen Youth Health Research Centre
35 Poplar Rd
3052 Parkville (Victoria)
Country 17152 0
Australia
Phone 17152 0
(+61) 401772668
Fax 17152 0
Email 17152 0
malvarez@unimelb.edu.au
Contact person for scientific queries
Name 8080 0
John Gleeson
Address 8080 0
School of Psychology /Faculty of Arts and Science
Australian Catholic University
115 Victoria Parade
3065 Fitzroy (Victoria)
Country 8080 0
Australia
Phone 8080 0
(+61) 3 99533108
Fax 8080 0
Email 8080 0
john.gleeson@acu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary