Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000743561
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
20/07/2015
Date last updated
29/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can transcranial direct current stimulation enhance positive emotional processing bias?
Scientific title
The Effect of Transcranial Direct Current Stimulation and Affective Modification Bias Training on Emotional Information Processing Bias and Electrophysiology in Healthy Adults
Secondary ID [1] 286988 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Affective processing bias in healthy adults 295460 0
Condition category
Condition code
Mental Health 295715 295715 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: 1 mA transcranial direct current stimulation (tDCS). Anodal stimulation will be applied to the left dorsolateral prefrontal cortex and the cathode will be placed over the right orbit. Stimulation will be delivered for for 20-minutes using a Starstim/Neuroelectrics stimulator and will be administered with concurrent attentional bias modification training. Attentional bias modification is a computerised dot-probe task. It involves simultaneous presentation of positive and negative stimuli and repeated orientation of attention towards the positive stimuli via dot probe.

All participants will complete two experimental sessions, one each of the following:

- active tDCS + attentional bias modification training
- sham tDCS + attentional bias modification training

Sessions will be conducted a minimum of 72-hours apart and interventions will be administered by a single trained researcher. Session order will follow a pre-determined randomisation schedule.

Intervention code [1] 292201 0
Treatment: Devices
Intervention code [2] 292202 0
Treatment: Other
Comparator / control treatment
Intervention 2: identical to Intervention 1 but sham (i.e. no current) rather than active tDCS will be applied concurrent with attentional bias modification training.
Control group
Active

Outcomes
Primary outcome [1] 295424 0
Pre versus post performance on attentional bias assessment task.

Attentional bias assessment task: the attentional bias assessment task is a computerised dot-probe task. It follows the same format as the attentional bias modification in that it involves simultaneous presentation of positive and negative stimuli. It differs in that the dot probes are are presented in a 50:50 positive: negative contingency and differences in reaction time to positive and negative stimuli are used to infer attentional bias.
Timepoint [1] 295424 0
Immediately post attentional bias modification training with active/sham tDCS.
Secondary outcome [1] 315563 0
Pre versus post intervention EEG activity during completion of an emotive sternberg working memory task.

Emotive Sternberg Task: comprises blocks of positive, neutral and negative stimuli. Differences in accuracy and reaction times by valence and stimulation condition will be examined.
Timepoint [1] 315563 0
Immediately post attentional bias modification training with active/sham tDCS.

Eligibility
Key inclusion criteria
1. Are voluntary and competent to consent
2. Are right handed
3. Have no history of traumatic brain injury, cognitive impairment (learning difficulty, ADHD), neurological or mental illness
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Are currently pregnant or lactating
2. Have epilepsy or a history of seizure
3. Currently taking any psychoactive medications
4. Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws and slips from surgical procedures

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2015
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
29/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291550 0
University
Name [1] 291550 0
Monash University
Country [1] 291550 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton, VIC
3168
Country
Australia
Secondary sponsor category [1] 290227 0
None
Name [1] 290227 0
Address [1] 290227 0
Country [1] 290227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293092 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 293092 0
Alfred Health Human Ethics Committee
Alfred Hospital
Commercial Rd
Prahran
3181 VIC
Ethics committee country [1] 293092 0
Australia
Date submitted for ethics approval [1] 293092 0
Approval date [1] 293092 0
16/12/2014
Ethics approval number [1] 293092 0
487/14

Summary
Brief summary
The study is investigating the capacity of tDCS to alter ‘emotional processing bias’. Emotional processing bias refers to the interaction of cognitive and emotional processing that result in unconscious preferential processing of emotional stimuli of a certain valence (e.g. unconscious preference for positive or negative stimuli and information). We all have unconscious biases in our emotional processing. A positive emotional processing bias has been linked to aspects of mental health and maladaptive biases are a key component of many mental illnesses, such as depression. Very few studies have investigated whether tDCS can alter emotional processing bias, and due to methodological limitations the findings of those small number that have are inconclusive. Also, no studies to date have investigated the patterns of brain activity associated with tDCS and bias modification.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58402 0
Dr Rebecca Segrave
Address 58402 0
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181
Country 58402 0
Australia
Phone 58402 0
+61 3 9076 5030
Fax 58402 0
Email 58402 0
[email protected]
Contact person for public queries
Name 58403 0
Dr Rebecca Segrave
Address 58403 0
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181
Country 58403 0
Australia
Phone 58403 0
+61 3 9076 5030
Fax 58403 0
Email 58403 0
[email protected]
Contact person for scientific queries
Name 58404 0
Dr Rebecca Segrave
Address 58404 0
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181
Country 58404 0
Australia
Phone 58404 0
+61 3 9076 5030
Fax 58404 0
Email 58404 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.