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Trial registered on ANZCTR


Registration number
ACTRN12618000100291
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
23/01/2018
Date last updated
17/02/2020
Date data sharing statement initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of stress on cortisol, endocannabinoids and cognitive processing
Scientific title
A Translational Investigation of the Influence of Ovarian Hormones on Endocannabinoid-Modulated Negative Feedback of the HPA Stress Response
Secondary ID [1] 293456 0
Nil known
Universal Trial Number (UTN)
U1111-1205-7784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPA stress response 305635 0
Condition category
Condition code
Mental Health 304856 304856 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 304857 304857 0 0
Normal metabolism and endocrine development and function
Neurological 304858 304858 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure to acute stress - Maastricht Acute Stress Test (MAST). In this paradigm, participants alternate between submerging their non-dominant hand in very cold (0-2 degrees) water (ICE) and completing a mental arithmetic (ARIT) task (counting backwards in 17s from 2043) for 10 minutes. In addition, they are informed that they will be monitored by the experimenter during the task and that their facial expressions would be video recorded for later examination. During the arithmetic task, the experimenter will monitor for incorrect reponses and they will be instructed to start again from 2043 whenever they get a number incorrect. Participants are not told how long each task will last, but that it will be a maximum of 90 seconds. The trial durations are as follows: ICE 90sec, ARIT 45sec, ICE 60sec, ARIT 60sec, ICE 60sec, ARIT 90sec, ICE 90sec, ARIT 45sec, ICE 60sec.
Intervention code [1] 299912 0
Behaviour
Comparator / control treatment
Participants may also be assigned to the MAST placebo, which is the same duration as the MAST and does not produce any stress response. Participants alternate between submerging their non-dominant hand in room temperature water (WATER) and completing a mental arithmetic (ARIT) task (counting backwards in 17s from 2043) for 10 minutes. In contrast to the stress condition, participants are not told they will be videotaped, and they complete the arithmetic task at their own pace, without any experimenter monitoring or feedback on incorrect responses. The trial durations are as follows: WATER 90sec, ARIT 45sec, WATER 60sec, ARIT 60sec, WATER 60sec, ARIT 90sec, WATER 90sec, ARIT 45sec, WATER 60sec.
Control group
Active

Outcomes
Primary outcome [1] 304057 0
anandamide (endocannabinoid) levels in saliva (and in blood for males only)
Timepoint [1] 304057 0
baseline, 5 minutes (primary endpoint), 30 minutes, 45 minutes
Primary outcome [2] 304058 0
Cortisol levels in saliva (and in blood for males only)
Timepoint [2] 304058 0
baseline, 5 minutes, 30 minutes (primary endpoint), 45 minutes
Primary outcome [3] 304286 0
2-AG (endocannabinoid) levels in saliva (and in blood for males only)
Timepoint [3] 304286 0
baseline, 5 minutes , 30 minutes, 45 minutes (primary endpoint)
Secondary outcome [1] 340811 0
reaction time on the n-back and attentional network tasks (females only)
Timepoint [1] 340811 0
Baseline and post-stress task completion
Secondary outcome [2] 341504 0
accuracy on the n-back and attentional network tasks (females only)
Timepoint [2] 341504 0
Baseline and post-stress task completion
Secondary outcome [3] 341505 0
Event-related potential measures of brain activity measured using electroencephalography (EEG) - N1 amplitude during performance of the attentional network task and n-back task (females only)
Timepoint [3] 341505 0
Baseline and post-stress task completion
Secondary outcome [4] 341506 0
Event-related potential measures of brain activity measured using electroencephalography (EEG) - N2 amplitude during performance of the attentional network task and n-back task (females only)
Timepoint [4] 341506 0
Baseline and post-stress task completion
Secondary outcome [5] 341508 0
Event-related potential measures of brain activity measured using electroencephalography (EEG) - P3 amplitude during performance of the attentional network task and n-back task (females only)
Timepoint [5] 341508 0
Baseline and post-stress task completion
Secondary outcome [6] 341509 0
The Subjective Units of Distress Scale (SUDS) is a brief self-report measure of acute distress The SUDS is rated on a scale of 0-100, with a rating of 0 being no distress, 50 being moderate distress and 100 being extreme distress. The SUDS has been recently validated as a clinically accurate measure of participant distress (Tanner, 2012).
Timepoint [6] 341509 0
5 minutes post-stress test completion

Eligibility
Key inclusion criteria
Participants will be healthy males and females in an age range of 18-40.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have a current psychiatric medication schedule or psychiatric diagnosis, current or history of regular illicit drug use, have an AUDIT score of 16 or above (indicative of heavy alcohol use), current tobacco use, history of head trauma, current pregnancy, epilepsy or seizures, sleep disorder, sleeping difficulties, skin sensitivities, existing cardiac or neurological condition, or uncorrected visual or auditory difficulties. In addition, given that we are measuring brain activity to verbal stimuli, participants will all have English as a first language. Participants will also be required to not have undergone the MAST stressor in the past.

Study design
Purpose of the study
Diagnosis
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
Type of endpoint/s
Statistical methods / analysis
A priori power analyses using G-Power 3.1.9.2 with a = 0.05 and ß = 0.20 were conducted. These analyses indicated that we will require approximately 24-30 male participants, with males being divided into conditions experiencing either the MAST or MAST placebo condition. This will allow us to detect an effect size of approximately f = 0.25, which was detectable in a similar study using the cold pressure test (Cheung, Chervonsky, Felmingham, & Bryant, 2013) and in the MAST validation studies (Smeets et al., 2012). Power analyses further indicated that we will require an additional 50 females to detect an effect of f = 0.2, with estrogen as a continuous predictor.

For the hormonal component of the study, we will adopt the analysis strategy of a previous study (Chouker et al., 2010) that used time as a within-subjects factor, with hormonal status as a continuous predictor, instead of using a median split on the oestrogen measurements. This analysis will therefore be a 4(Time: baseline, post+5, post+30, post+45) RM-ANOVA design on each of the lipid concentrations (anandamide, cortisol and 2-AG),

Data analysis for the cognitive tasks tasks will be achieved using mixed model ANOVAs for each dependent variable. For instance, for the attenional network task, reaction time will be assessed using 2(Task: before MAST, after MAST) x 2(Cue: no cue, central, spatial) x 2(Congruency: congruent and incongruent) mixed models ANOVA, with oestrogen levels as a covariate. For P1, N1, N2 and P3 ERP components, analyses will be conducted in the form 2(Task: before MAST, after MAST) x 2(Cue: no cue, central, spatial) x 2(Congruency: congruent and incongruent) x 2(Hemisphere: left and right), with oestrogen as a covariate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2018
Actual
13/04/2018
Date of last participant enrolment
Anticipated
31/03/2019
Actual
21/02/2019
Date of last data collection
Anticipated
13/04/2019
Actual
21/02/2019
Sample size
Target
80
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 18160 0
7001 - Hobart

Funding & Sponsors
Funding source category [1] 298081 0
University
Name [1] 298081 0
University of Melbourne
Country [1] 298081 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Division of Psychology
School of Medicine
University of Tasmania
Private Bag 30
Hobart, Tasmania, Australia, 7001
Country
Australia
Secondary sponsor category [1] 297159 0
None
Name [1] 297159 0
Address [1] 297159 0
Country [1] 297159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299103 0
University of Tasmania HREC - Health and Medical
Ethics committee address [1] 299103 0
Ethics committee country [1] 299103 0
Australia
Date submitted for ethics approval [1] 299103 0
21/08/2017
Approval date [1] 299103 0
04/12/2017
Ethics approval number [1] 299103 0
H0016793

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

Contacts
Principal investigator
Name 79298 0
Dr Allison Matthews
Address 79298 0
Division of Psychology
School of Medicine
University of Tasmania
Private Bag 30
Hobart, Tasmania, 7001
Country 79298 0
Australia
Phone 79298 0
+61 3 62267236
Fax 79298 0
Email 79298 0
Allison.Matthews@utas.edu.au
Contact person for public queries
Name 79299 0
Allison Matthews
Address 79299 0
Division of Psychology
School of Medicine
University of Tasmania
Private Bag 30
Hobart, Tasmania, 7001
Country 79299 0
Australia
Phone 79299 0
+61 3 62267236
Fax 79299 0
Email 79299 0
Allison.Matthews@utas.edu.au
Contact person for scientific queries
Name 79300 0
Allison Matthews
Address 79300 0
Division of Psychology
School of Medicine
University of Tasmania
Private Bag 30
Hobart, Tasmania, 7001
Country 79300 0
Australia
Phone 79300 0
+61 3 62267236
Fax 79300 0
Email 79300 0
Allison.Matthews@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not currently decided to share any IPD


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.