Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000806763
Ethics application status
Approved
Date submitted
25/05/2022
Date registered
8/06/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
8/06/2022
Date results provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interaction between learning bias and stress as modulator of cognitive flexibility and fear extinction.
Scientific title
Stress exposure modulation of fear acquisition, extinction and cognitive flexibility in positive and negative learners.
Secondary ID [1] 307214 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning bias 326452 0
Condition category
Condition code
Mental Health 323729 323729 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, all participants will complete the probabilistic selection task which has been described as measure of trial-and-error procedural learning, and can be used to identify whether one is better at learning from trials that are most likely to be reinforced (also known as a positive learning bias) or from avoiding trials with the least positively reinforced (or most punished) items. Depending on accuracy performance on the above trials, participants will be categorized as either being positive or negative learners.
This cognitive task will be administered online (through a platform called Pavlovia) and will last approximately 10 minutes.

Following categorization of participants as either positive or negative learners, a group of participants (n=70) will complete a test of cognitive flexibility known as the Wisconsin Card Sorting test. The test will be administed in the lab and lasts approximately 30 minutes.

All participants will then be randomly assigned to take part in either the socially evaluated cold pressor test (experimental treatment) or the socially evaluated warm test (control condition). In the former condition, the researcher will be dressed up in a lab coat and will instruct participants to immerge their right hand into ice-cold water (0-4 Celcius; to be measured using a thermemoter before the participant immerges his/her hand) for as long as possible and a maximum duration of 3 minutes. Participants will also be instructed that their facial expression will be recorded for further analysis.

Following the stress exposure, a group of participants (n=70) will complete the cognitive flexibility task for a second time, whereas a second group of participants (n=30), will have their electrodermal activity recorded (by attaching two electrodes to the middle and ring finger of a participant) during a fear acquisition and extinction task. In the fear acquisition task, a visual stimulus (CS+) will predict the occurrence of a 95db loud sound (delivered through headphones for 1 second), whereas a second visual stimulus (CS-) will predict the occurrence of a neutral fixation dot.
In the fear extinction phase, the CS- will no longer be paired with the loud stimulus. The task lasts 15 minutes.
Intervention code [1] 323658 0
Treatment: Other
Intervention code [2] 323714 0
Behaviour
Comparator / control treatment
The comparison/control condition is identical to the experimental condition with the exception that participants will immerge their hand in water that is 35-37 degree celsius.
Control group
Active

Outcomes
Primary outcome [1] 331479 0
Electrodermal activity responses during fear acquisition by the application of two metal electrodes (1cm in diameter) attached to the middle and ring finger of a participant via isotonic gel and secured by tape.
Timepoint [1] 331479 0
10 minutes following the Socially Evaluated Cold Pressor Test.
Primary outcome [2] 331480 0
Electrodermal activity responses during fear extinction by the application of two metal electrodes (1cm in diameter) attached to the middle and ring finger of a participant via isotonic gel and secured by tape.
Timepoint [2] 331480 0
20 minutes following the Socially Evaluated Cold Pressor Test.
Primary outcome [3] 331481 0
Total errors in the Wisconsin Card Sorting task
Timepoint [3] 331481 0
Immediately before the Socially Evaluated Cold Pressor Test. and 10 minutes following the Socially Evaluated Cold Pressor Test.
Secondary outcome [1] 410045 0
Perseverative errors in Wisconsin Card Sorting Test
Timepoint [1] 410045 0
Immediately before the Socially Evaluated Cold Pressor Test. and 10 minutes following the Socially Evaluated Cold Pressor Test.
Secondary outcome [2] 410046 0
Reaction times in the Wisconsin Card Sorting task
Timepoint [2] 410046 0
Immediately before the Socially Evaluated Cold Pressor Test. and 10 minutes following the Socially Evaluated Cold Pressor Test.

Eligibility
Key inclusion criteria
• You are in good health
• You agree to fast 3 hours prior to testing
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Suffer from cardiac, hepatic, renal, and/or neurological disorders
• Have a history of alcohol or drug addiction, or severe psychiatric illness
• Are pregnant
• Are sleep deprived (less than 6 hours a day)

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)
I, as the researcher randomising the participant do not know what the next treatment allocation will be as A) testing is carried out by my students B) assignment to the cold pressor or warm pressor test is dependent on participant performance on the probabilistic seleciton task.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Factorial mixed design ANOVAs.
This is a factorial design as there are two interventions (or independent variables) each with two levels and forming the following groups:
1) categorized as positive learner + exposed to the socially evaualted cold pressor test
2) categorized as positive learner + exposed to the socially evaluated warm pressor test
3) categorized as negative learner+exposed to the socially evaualted cold pressor test
4) categorized as negative learner+ exposed to the socially evaluated warm pressor test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2022
Date of last participant enrolment
Anticipated
16/09/2022
Actual
2/09/2022
Date of last data collection
Anticipated
16/09/2022
Actual
16/09/2022
Sample size
Target
100
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311514 0
University
Name [1] 311514 0
Murdoch University
Country [1] 311514 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, 6150, WA.
Country
Australia
Secondary sponsor category [1] 312925 0
None
Name [1] 312925 0
Address [1] 312925 0
Country [1] 312925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310975 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 310975 0
Ethics committee country [1] 310975 0
Australia
Date submitted for ethics approval [1] 310975 0
Approval date [1] 310975 0
12/05/2022
Ethics approval number [1] 310975 0

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

Contacts
Principal investigator
Name 119554 0
Dr Luca Aquili
Address 119554 0
Murdoch University
90 South Street,
Murdoch, 6150,
WA
Country 119554 0
Australia
Phone 119554 0
+61 89360 2348
Fax 119554 0
Email 119554 0
[email protected]
Contact person for public queries
Name 119555 0
Luca Aquili
Address 119555 0
Murdoch University
90 South Street,
Murdoch, 6150,
WA
Country 119555 0
Australia
Phone 119555 0
+61 89360 2348
Fax 119555 0
Email 119555 0
[email protected]
Contact person for scientific queries
Name 119556 0
Luca Aquili
Address 119556 0
Murdoch University
90 South Street,
Murdoch, 6150,
WA
Country 119556 0
Australia
Phone 119556 0
+61 89360 2348
Fax 119556 0
Email 119556 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?

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
SourceTitleYear of PublicationDOI
Dimensions AILearning bias predicts fear acquisition under stress but not cognitive flexibility2023https://doi.org/10.1016/j.physbeh.2023.114384
N.B. These documents automatically identified may not have been verified by the study sponsor.