Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000512224
Ethics application status
Approved
Date submitted
26/03/2018
Date registered
9/04/2018
Date last updated
17/09/2020
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Stimulating social cognition in first-episode psychosis
Scientific title
Self-other processing in first-episode psychosis: a high-definition transcranial direct current stimulation study
Secondary ID [1] 294451 0
None
Universal Trial Number (UTN)
U1111-1211-3709
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 307200 0
Condition category
Condition code
Mental Health 306310 306310 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation to the dorsomedial prefrontal cortex and right temporoparietal junction. 1mA for 20 minutes using ring electrodes with a centre electrode (2.5cm in diameter) and return electrodes with inner and outer diameter of 9.2/11.5cm for the dmPFC and 7.5/9.8 for the rTPJ. The current ramps up over 8 seconds before remaining for 20 minutes at 1 mA and the ramping down over 5 seconds.
Stimulation will be administered by a research officer and or research assistant. Testing takes place over two days with active on one day and placebo on the other day (counterbalanced) and at least 3 days in between to ensure wash out. The social cognitive battery takes approximately 60 minutes to complete, although stimulation will only be "online for 20 minutes" from the start of the testing. For the remaining 40 minutes, participants will not be actively receiving stimulation although the neural excitatory effects of stimulation will still be present while they complete the remainder of the cognitive battery.
Intervention code [1] 300739 0
Treatment: Devices
Comparator / control treatment
A sham or placebo stimulation session will be used as a control. The sham stimulation ramps up the current over 8 seconds and stays on for 40 seconds before ramping down over 5 seconds. This induces the same physical sensation as the active stimulation but without physiological effects.
Control group
Placebo

Outcomes
Primary outcome [1] 305318 0
Cognitive performance on a social cognitive battery including the Reading the Mind in the Eyes test, a novel visual perspective taking task able to measure implicit and explicit perspective taking and an episodic memory task that relies on either self or other-related encoding. This will be used to measure the self-reference effect in episodic and source memory. These are composite measure to assess self-other processing across cognitive domains
Timepoint [1] 305318 0
All social cognitive measures are assessed during stimulation (first 20 minutes) or in the period after stimulation has stopped but the physiological effects of active stimulation remain (60 minutes). The Reading the Mind in the Eyes test will be completed during "online" active stimulation whereas the visual perspective taking and episodic memory tasks will be completed during "offline" active stimulation.
Secondary outcome [1] 344831 0
none
Timepoint [1] 344831 0
none

Eligibility
Key inclusion criteria
First episode psychosis patients who are Caucasian with English as first language.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological disease/trauma (including seizures/migraine)
Non-Caucasian
Substantial current substance abuse
Medical devices not compatible with transcranial direct current stimulation

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 receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
We will conduct a sham-controlled, double-blinded, crossover study. Each subject will receive both sham and active stimulation over two days separated by at least 3 days.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures analysis of variance
Mixed effects models

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
28/09/2018
Date of last participant enrolment
Anticipated
17/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
60
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10477 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 13736 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 22190 0
4029 - Herston
Recruitment postcode(s) [2] 26483 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 299076 0
University
Name [1] 299076 0
The University of Queensland
Country [1] 299076 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 298317 0
None
Name [1] 298317 0
Address [1] 298317 0
Country [1] 298317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300011 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 300011 0
Ethics committee country [1] 300011 0
Australia
Date submitted for ethics approval [1] 300011 0
29/01/2018
Approval date [1] 300011 0
23/03/2018
Ethics approval number [1] 300011 0
HREC/18/QRBW/58

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

Contacts
Principal investigator
Name 82254 0
Dr Andrew Martin
Address 82254 0
UQCCR
RBWH Campus
Herston, 4029
QLD
Country 82254 0
Australia
Phone 82254 0
+61 7 33465060
Fax 82254 0
Email 82254 0
[email protected]
Contact person for public queries
Name 82255 0
Andrew Martin
Address 82255 0
UQCCR
RBWH Campus
Herston, 4029
QLD
Country 82255 0
Australia
Phone 82255 0
+61 7 33465060
Fax 82255 0
Email 82255 0
[email protected]
Contact person for scientific queries
Name 82256 0
Andrew Martin
Address 82256 0
UQCCR
RBWH Campus
Herston, 4029
QLD
Country 82256 0
Australia
Phone 82256 0
+61 7 33465060
Fax 82256 0
Email 82256 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9195Study protocol  [email protected]
9196Statistical analysis plan  [email protected]



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.