Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12620001068954
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluating mental health professional attitudes of a new treatment for post-traumatic stress disorder (PTSD)
Query!
Scientific title
Evaluating the atittudes of Australian psychologists, psychiatrists and mental health researchers towards 3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for the treatment of PTSD: A double-blind, randomised controlled trial
Query!
Secondary ID [1]
302100
0
NIL known
Query!
Universal Trial Number (UTN)
U1111-1257-2811
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Attitudes of mental health professionals
318729
0
Query!
Post-traumatic stress disorder
319354
0
Query!
Condition category
Condition code
Mental Health
316733
316733
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Potential participants are being directed to an online survey, via a URL received in an online advertisment. The survey was designed specificaly for this study and takes approximately 10 minutes to complete.
The intervention involves reading a vignette of a hypothetical patient with a diagnosis of PTSD, who has tried several pharmacological and psychotherapeutic treatments that have failed to ameliorate their symptoms. The patient is seeking advice about participating in a Phase-III clinical trial assessing a novel pharmacotherapy treatment. The vignettes are identical except for the descriptions of the treatments. 1) Experimental group: “Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for the treatment of PTSD, as part of a phase 3 clinical trial. MDMA is commonly known as the active chemical from the party drug ‘ecstasy’”; 2) Control group: “JB-4801-assisted psychotherapy for the treatment of PTSD, as part of a phase 3 clinical trial. JB-4801 is a new drug being developed by the University”. Both vignettes stated “preliminary studies have suggested this treatment has worked for a high proportion of people with PTSD and has very low chance for negative side-effects”.
Once participants complete the questions on the page containing the vignette and progress through the survey, they can no longer read the vignette. They are able to complete the survey using any device that can connect to the internet, at any time within the data collection period. There is no time limit to complete the survey, so long as it falls within this period. They require no direct contact with study personnel. The vignettes were designed by three mental health professionals, working within psychiatry, psychology and mental health research.
Query!
Intervention code [1]
318406
0
Behaviour
Query!
Comparator / control treatment
The control intervention is the vignette description of a fabricated pharmcotherapy for the treatment of PTSD: "JB-4801-assisted psychotherapy". A fabricated compound ensures participants have no prior beliefs about the described treatment.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
324900
0
The subjective level of concern about the safety of the described treatment, assessed on a 10-point likert scale (1="not at all"; 10="extremely")
Query!
Assessment method [1]
324900
0
Query!
Timepoint [1]
324900
0
Single timepoint, ranging from February 2020 to November 2020.
Query!
Secondary outcome [1]
386166
0
The predicted efficacy of the described treatment, measured on a 10-point likert scale.
Query!
Assessment method [1]
386166
0
Query!
Timepoint [1]
386166
0
Single timepoint, ranging from February 2020 to November 2020.
Query!
Secondary outcome [2]
386167
0
The likelihood of objecting to participating in the described treatment, measured on a 10-point likert scale.
Query!
Assessment method [2]
386167
0
Query!
Timepoint [2]
386167
0
Single timepoint, ranging from February 2020 to November 2020.
Query!
Secondary outcome [3]
386168
0
The likelihood that they would recommend participating in the described treatment, as measured by a 10 point likert scale.
Query!
Assessment method [3]
386168
0
Query!
Timepoint [3]
386168
0
Single timepoint, ranging from February 2020 to November 2020.
Query!
Eligibility
Key inclusion criteria
Participants must be working within Australia as a psychologist, psychiatrist or mental health researcher.
Psychologists and psychiatrists must be registered with AHPRA.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
People under the age of 18.
People who do not work in Australia.
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer software,
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation, stratified by primary profession (i.e. psychiatrist, psychologist or mental health researcher)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/02/2020
Query!
Date of last participant enrolment
Anticipated
1/11/2020
Query!
Actual
Query!
Date of last data collection
Anticipated
2/11/2020
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
100
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
306518
0
University
Query!
Name [1]
306518
0
University of Sydney, School of Psychology
Query!
Address [1]
306518
0
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Query!
Country [1]
306518
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Sydney
Query!
Address
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Query!
Country
Australia
Query!
Secondary sponsor category [1]
307051
0
None
Query!
Name [1]
307051
0
Query!
Address [1]
307051
0
Query!
Country [1]
307051
0
Query!
Other collaborator category [1]
281435
0
Individual
Query!
Name [1]
281435
0
Professor Nick Glozier
Query!
Address [1]
281435
0
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Query!
Country [1]
281435
0
Australia
Query!
Other collaborator category [2]
281436
0
Individual
Query!
Name [2]
281436
0
Associate Professor Ben Colagiuri
Query!
Address [2]
281436
0
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Query!
Country [2]
281436
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
306722
0
University of Sydney Human Research Ethics Committee
Query!
Ethics committee address [1]
306722
0
Research Integrity & Ethics Administration Research Portfolio Level 3, F23 Administration Building The University of Sydney NSW 2006 Australia
Query!
Ethics committee country [1]
306722
0
Australia
Query!
Date submitted for ethics approval [1]
306722
0
Query!
Approval date [1]
306722
0
12/12/2019
Query!
Ethics approval number [1]
306722
0
2019/872
Query!
Summary
Brief summary
We aim to evaluate the attitudes of mental health professionals towards MDMA-therapy trials by a comparison of attitudes to a neutrally-labelled pharmacotherapy, using a double-blind, randomised controlled vignette study design. We hypothesise that mental health professionals will have the following differences in attitudes towards MDMA-therapy, when compared a neutrally-labelled pharmacotherapy: 1) higher concerns for safety; 2) Lower predicted efficacy; 3) stronger objections to participation and/or lower levels of recommending participation. By assessing professional attitudes towards MDMA-therapy for PTSD using an experimental study, we can understand if there are any biases that may be inhibiting conducting research in this area, or inhibiting the uptake of this potential new treatment by clinicians.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
104794
0
Prof Nick Glozier
Query!
Address
104794
0
Brain and Mind Centre, University of Sydney
94 Mallett St, Camperdown NSW 2050
Query!
Country
104794
0
Australia
Query!
Phone
104794
0
+61 2 9515 1596
Query!
Fax
104794
0
Query!
Email
104794
0
nick.glozier@sydney.edu.au
Query!
Contact person for public queries
Name
104795
0
Dean Wright
Query!
Address
104795
0
Brain and Mind Centre, University of Sydney
94 Mallett St, Camperdown NSW 2050
Query!
Country
104795
0
Australia
Query!
Phone
104795
0
+61 2 9114 4343
Query!
Fax
104795
0
Query!
Email
104795
0
dean.wright@sydney.edu.au
Query!
Contact person for scientific queries
Name
104796
0
Dean Wright
Query!
Address
104796
0
Brain and Mind Centre, University of Sydney
94 Mallett St, Camperdown NSW 2050
Query!
Country
104796
0
Australia
Query!
Phone
104796
0
+61 2 9114 4343
Query!
Fax
104796
0
Query!
Email
104796
0
dean.wright@sydney.edu.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified responses to outcome variables, including demographic information.
Query!
When will data be available (start and end dates)?
Available after July 2021, until July 2026
Query!
Available to whom?
Scientific community
Query!
Available for what types of analyses?
Any analyses approved by a recognised ethics committee.
Query!
How or where can data be obtained?
via email to dean.wright@sydney.edu.au
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Statistical analysis plan
dean.wright@sydney.edu.au
Informed consent form
dean.wright@sydney.edu.au
Clinical study report
dean.wright@sydney.edu.au
Available upon study completion and publication
Study protocol
dean.wright@sydney.edu.au
Ethical approval
dean.wright@sydney.edu.au
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Evaluating the attitudes of mental health professionals towards trials of MDMA: a randomised vignette trial.
2022
https://dx.doi.org/10.1136/bmjopen-2021-060360
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF