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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
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

Study type
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

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
Timepoint [1] 344831 0

Key inclusion criteria
First episode psychosis patients who are Caucasian with English as first language.
Minimum age
18 Years
Maximum age
35 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Neurological disease/trauma (including seizures/migraine)
Substantial current substance abuse
Medical devices not compatible with transcranial direct current stimulation

Study design
Purpose of the study
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
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.
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Repeated measures analysis of variance
Mixed effects models

Recruitment status
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 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
Name [1] 299076 0
The University of Queensland
Address [1] 299076 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 299076 0
Primary sponsor type
The University of Queensland
The University of Queensland
Brisbane QLD 4072 Australia
Secondary sponsor category [1] 298317 0
Name [1] 298317 0
Address [1] 298317 0
Country [1] 298317 0

Ethics approval
Ethics application status
Ethics committee name [1] 300011 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 300011 0
Level 7, Block 7
Royal Brisbane & Women's Hospital
Herston Qld 4029
Ethics committee country [1] 300011 0
Date submitted for ethics approval [1] 300011 0
Approval date [1] 300011 0
Ethics approval number [1] 300011 0

Brief summary
Transcranial direct current stimulation is a cheap, portable device that may have application as a clinical tool for cognitive remediation. In the current study we will assess the effectiveness of high-definition transcranial direct current stimulation (HD-tDCS) to the dorsomedial prefrontal cortex (dmPFC) and right temporoparietal junction (rTPJ) to affect social cognition in patients with first-episode psychosis. We hypothesize that the patient group will show impairments at integrating and distinguishing between self and other processes across perspective taking and episodic memory tasks. They will also be impaired on an affective theory of mind (ToM) task. We hypothesize that dmPFC anodal stimulation will increase the integration of other into self across perspective taking and episodic memory tasks and improve affective ToM performance. Anodal stimulation to the rTPJ will improve the ability to inhibit the self-perspective in a perspective taking task that relies on mental rotation.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 82254 0
Dr Andrew Martin
Address 82254 0
RBWH Campus
Herston, 4029
Country 82254 0
Phone 82254 0
+61 7 33465060
Fax 82254 0
Email 82254 0
Contact person for public queries
Name 82255 0
Dr Andrew Martin
Address 82255 0
RBWH Campus
Herston, 4029
Country 82255 0
Phone 82255 0
+61 7 33465060
Fax 82255 0
Email 82255 0
Contact person for scientific queries
Name 82256 0
Dr Andrew Martin
Address 82256 0
RBWH Campus
Herston, 4029
Country 82256 0
Phone 82256 0
+61 7 33465060
Fax 82256 0
Email 82256 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Summary results
No Results