Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000963820
Ethics application status
Approved
Date submitted
5/09/2012
Date registered
7/09/2012
Date last updated
7/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the effectiveness of an internet-based treatment program for psychotic like experiences.
Scientific title
An evaluation of the effectiveness of an internet-based treatment program for psychotic like experiences.
Secondary ID [1] 281177 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic like experiences (subclinical psychosis) 287343 0
Condition category
Condition code
Mental Health 287681 287681 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this Study, it is proposed that a delayed treatment randomised controlled trial will review the effectiveness of the internet-based self help program Ontrack GetReal. The trial will involve a wait list (control group) and an intervention group. The wait list will be offered the intervention three months later.

Ontrack GetReal is a free online treatment program for people who are having odd or unusual experiences. The program may also help people in the early stages of psychosis, where they may be hearing voices or feel suspicious of other people. The program uses targeted evidence based therapy techniques that have been shown in research to be helpful with PLE’s.

The overall aims of this study are:
1. To reduce distress associated with psychotic like experiences (PLEs)
2. To improve help seeking behaviours of young people if distressed
3. To determine if having e-support/ therapist contact assists in achieving the above outcomes.

This internet based delayed treatment trial will compare two different Groups.

Group 1 (control) allocated participants will firstly be placed on a wait list where they will complete the baseline assessments but not be offered access to the GetReal program for 3 months. They will receive an email each month to inform them that they are still ‘waiting’ ‘due to high demand’ and they will shortly be given access.

Group 2 (intervention) will get full access to the GetReal program as well as access to an e-support/ therapist that will send automated step-care intervention emails based at re-engaging a participant who may “log on” for transient experience or unusual thought and then not continue to use the program. This group will receive 4 emails across the 3 month period. This email will review their use of the program and to prompt them to re-engage with the GetReal program should they require it.

This study will be in a delayed treatment format to determine if the Getreal program improves the outcomes relating to (i) reducing any distress associated with odd or unusual experiences (ii) and/or increasing early help seeking behaviours compared to participants using a self-help program themselves.

Participants will be randomly allocated to either the control or intervention group by a predetermined list of allocation. They will then complete all baseline measures and either (a) be placed on a wait list for 3 months or (b) have immediate access to the getreal program.
Intervention code [1] 285626 0
Treatment: Other
Comparator / control treatment
no access to treatment for 3 months - wait list. But then, full access to treatment program.
Control group
Active

Outcomes
Primary outcome [1] 287924 0
To determine the effectivness of the Ontrack Getreal program for reducing the frequency and PLES in young people and the level of distress associated with them
Timepoint [1] 287924 0
Measures used:
There are pre and post measures already in-built to the GetReal Program that monitor odd or unusual thoughts in young people and associated distress. These are collected at baseline, 3 months and 6 months.

(i) A modified CAPE (positive scale). The CAPE (positive scale) is a 20 item self-report measures of positive subthreshold PLEs. It uses a 4-point likert scale to indicate symptom frequency (never, sometimes,often,nearly always). It will be modified to ask,over the past three months, rather than, in your lifetime. Young people will be asked to rate a 0-100 point visual analogue scale at the end of the CAPE, to indicate their current level of distress related to the positive PLEs.

(ii) K10. The K10 (Kessler psychological distress scale) is a 10 item self-report measure of psychological distress related to anxiety and depressive symptoms in the past 4 weeks. Responses are rated on a 5 point scale (none of the time, a little of the time, Some of the time, Most of the time, All of the time) which is summed to provide a total score.

A baseline telephone interview using the CIDI will be used to add rigor to the built in assessments. The Composite International Diagnostic Interview (CIDI)is a comprehensive, fully-structured interview designed to be used by trained lay interviewers for the assessment of mental disorders according to the definitions and criteria of ICD-10 and DSM-IV. It is intended for use in epidemiological and cross-cultural studies as well as for clinical and research purposes. The diagnostic section of the interview is based on the World Health Organization's Composite International Diagnostic Interview (WHO CIDI, 1990). The CIDI allows the investigator to: - Measure the prevalence of mental disorders - Measure the severity of these disorders - Determine the burden of these disorders - Assess service use - Assess the use of medications in treating these disorders - Assess who is treated, who remains untreated, and what are the barriers to treatment. Only the psychosis screen of the CIDI will be used.
Secondary outcome [1] 299060 0
Nil
Timepoint [1] 299060 0
nil

Eligibility
Key inclusion criteria
Participants must be able to access and use the internet
They must be over 18 years
They must score a CAPE positive total score >10 and a K10 score of >/ 17.
Minimum age
18 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Below the age of 18 years
Current florid psychosis

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)
Approval to conduct this study will be obtained through Queensland University of Technology (QUT) Ethics committee. The previously approved study (“A cross sectional survey –No1100000187 ”) will be the source of recruitment, as any participant who completes the survey, meets the criteria for this study and has indicated that they would like to be contacted will be offered the information to be involved in this study.

1. Participants will be identified as meeting the required criteria. That Is, they will need to score on the CAPE assessment a score of at least 10 and 17>/ K10.
2. Participants will be offered the option to join the study via an email. This email will contain the QUT endorsed recruitment flyer, participant information support and consent form.
3. Consent from participants will be obtained at the start of logging into the GetReal program and they cannot participate in this study until consent is acknowledged
4. A baseline CIDI telephone interview will be completed and the approval for the Getreal program given.
4. Randomisation to either the control group or the intervention group will be by using a predetermined list generated from a random number table. Participants who consent and tick they ‘agree’ to participate will be allocated accordingly.
5. Participants in the control group will then be placed on a waitlist and be sent an email notifying them of this. They will get an email each month up to 3 months where they will be given access to the GetReal program.
6. Participants allocated to the intervention group will direct themselves through the program, but after two weeks will receive the first 'e-therapis/ support' email. This will support them to continue.
7. Participation for both groups will be for a period of 3 months. However, the control group will be involved for 6 months, due to a 3 month ‘lag’ on the wait list. Once in the intervention group, participants will have contact from a e-therapist at week 2, week 4, week 8 and week 12 (completion).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A predetermine list will be generated and the prinicnple resreacher is blinded to this process. Once a person has completed all baseline mesure and approval into eth study has be given, they are allocated to the next predetermined group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
delayed treatment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285948 0
Self funded/Unfunded
Name [1] 285948 0
PhD study with no paid scholarship
Country [1] 285948 0
Primary sponsor type
University
Name
Queensland Univeristy of Technology (QUT)
Address
Institute of health and biomedical innovation (IHBI)
60 Musk Avenue
Kelvin Grove
Brisbane
Queensland 4059
Country
Australia
Secondary sponsor category [1] 284772 0
None
Name [1] 284772 0
Address [1] 284772 0
Country [1] 284772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287983 0
Queensland University of Technology(QUT) Research Ethics Unit
Ethics committee address [1] 287983 0
Ethics committee country [1] 287983 0
Australia
Date submitted for ethics approval [1] 287983 0
Approval date [1] 287983 0
28/08/2012
Ethics approval number [1] 287983 0
1100000663

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

Contacts
Principal investigator
Name 34674 0
Address 34674 0
Country 34674 0
Phone 34674 0
Fax 34674 0
Email 34674 0
Contact person for public queries
Name 17921 0
MS Carina Capra
Address 17921 0
Institute of health and biomedical innovation (IHBI)
60 Musk Avenue
Kelvin Grove
Brisbane
Queensland 4059
Country 17921 0
Australia
Phone 17921 0
+ 61 7 3138 6144
Fax 17921 0
Email 17921 0
[email protected]
Contact person for scientific queries
Name 8849 0
Carina Capra
Address 8849 0
Institute of health and biomedical innovation (IHBI)
60 Musk Avenue
Kelvin Grove
Brisbane
Queensland 4059
Country 8849 0
Australia
Phone 8849 0
+ 61 7 3138 6144
Fax 8849 0
Email 8849 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes schizophrenia Bulletin, Psychiatry research

Documents added automatically
No additional documents have been identified.