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Trial registered on ANZCTR


Registration number
ACTRN12619000681156p
Ethics application status
Submitted, not yet approved
Date submitted
3/05/2019
Date registered
7/05/2019
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Environmental Enrichment and Stress on Psoriasis
Scientific title
The Effect of Environmental Enrichment Interventions and Stress on Psoriasis Outcomes in Adults with Chronic Plaque Psoriasis
Secondary ID [1] 298131 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 312664 0
Psychological Stress 312714 0
Condition category
Condition code
Skin 311164 311164 0 0
Dermatological conditions
Mental Health 311209 311209 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Interaction with the companion robot, Paro
Participants will be exposed to a laboratory stress task (the Trier Social Stress Task) to induce psychological stress. stress. In this speech task, participants will be instructed by the researcher that they are going to be giving a 5 minute speech to convince the experimenter to give them their dream job. They will be told that their speech will be recorded and that their performance on the task will be evaluated in terms of fluency and the winner will receive a $100 voucher. They will have 3 minutes to prepare their speech, and then 5 minutes to present their speech to the researcher and video-camera.
After this, participants will be randomised to either received the seal companion robot, Paro, as a form of environmental enrichment or to a control group. The Paro seal robot is a therapeutic robot designed to provide a safer alternative to animal-assisted therapy. Paro uses sensors to respond to human contact in a socially supportive and comforting way and has a soft fur coat to provide tactile comfort. Participants will be asked to interact with Paro during a 30 minute recovery period. They will be left alone with the Paro robot, during this time.
The intervention will only be delivered to the participants in a one-off, 90 minute session. This procedure will occur in a research clinic at the University of Auckland
Intervention code [1] 314356 0
Treatment: Devices
Comparator / control treatment
The control group will have no form of enrichment during the 30 minute recovery period and will instead be asked to sit quietly for 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 319935 0
Change in trans-epidermal water loss (TEWL) as measured using the Tewameter TM 300
Timepoint [1] 319935 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention
Primary outcome [2] 319936 0
Change in chemical and biological composition of the psoriatic lesion as measured using Raman Spectroscopy
Timepoint [2] 319936 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention
Secondary outcome [1] 369927 0
Mood as measured by the PANAS scale
Timepoint [1] 369927 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention
Secondary outcome [2] 369928 0
Changes in current stress levels as measured using 100mm visual analogue scales
Timepoint [2] 369928 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention
Secondary outcome [3] 369929 0
Changes in current anxiety levels as measured using 100mm visual analogue scales
Timepoint [3] 369929 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention
Secondary outcome [4] 369930 0
Changes in current pain levels as measured using 100mm visual analogue scales
Timepoint [4] 369930 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention
Secondary outcome [5] 369931 0
Changes in current relaxation levels as measured using 100mm visual analogue scales
Timepoint [5] 369931 0
Baseline, immediately after the stress task and immediately after the 30 minute intervention

Eligibility
Key inclusion criteria
Have chronic plaque psoriasis
Over 16 years of age
Can read and write in English fluently
Can provide written informed consent
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have another significant dermatological condition
People on any current systemic (oral) therapy for psoriasis including cyclosporin, methotrexate, acitretin, biologic agents or phototherapy. If they have recently stopped systemic treatments for psoriasis, they must be off all systemic treatments for at least 3 months
People on any other immunosuppressive medication, such as systemic corticosteroids
People who have recently changed depression or anxiety medications

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)
Randomisation to condition will be done by another researcher who is not conducting the experiment. Group allocation will be concealed from the participant and researcher until the time of the intervention. At this point, the researcher will open a sealed envelope which contains the randomised group allocation for that participant.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21450 0
New Zealand
State/province [1] 21450 0
Auckland

Funding & Sponsors
Funding source category [1] 302660 0
University
Name [1] 302660 0
The University of Auckland
Address [1] 302660 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 302660 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 302589 0
None
Name [1] 302589 0
Address [1] 302589 0
Country [1] 302589 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303283 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 303283 0
Office of the Vice Chancellor, Research Office
Alfred Nathan House, The University of Auckland
Private Bag 92019, Auckland 1142
Ethics committee country [1] 303283 0
New Zealand
Date submitted for ethics approval [1] 303283 0
30/04/2019
Approval date [1] 303283 0
Ethics approval number [1] 303283 0

Summary
Brief summary
This study aims to investigate whether the seal companion robot, Paro, can improve psoriasis outcomes and decrease physiological and psychological stress after exposure to an experimental stress task in patients with chronic plaque psoriasis. It is hypothesised that those psoriasis patients provided with a Paro robot will have better psoriasis outcomes (as measured by TEWL and Raman micro-spectroscopy) and lower psychological and physiological stress levels than control participants who are not given the Paro robot .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93126 0
Prof Elizabeth Broadbent
Address 93126 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 93126 0
New Zealand
Phone 93126 0
+649 373 7599 Ext. 86756
Fax 93126 0
Email 93126 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 93127 0
Prof Elizabeth Broadbent
Address 93127 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 93127 0
New Zealand
Phone 93127 0
+649 373 7599 Ext. 86756
Fax 93127 0
Email 93127 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 93128 0
Prof Elizabeth Broadbent
Address 93128 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 93128 0
New Zealand
Phone 93128 0
+649 373 7599 Ext. 86756
Fax 93128 0
Email 93128 0
e.broadbent@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Each individual’s data will be pooled together with the data of the other participants of the study and subjected to statistical analysis. Confidentiality will be maintained at all times. The results of any group analysis may be published in peer reviewed scientific journals, presented at conferences and used in a doctoral thesis. The raw videos will not be used in any outputs or be publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results