Trial Review

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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)
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
Secondary ID [1] 302100 0
NIL known
Universal Trial Number (UTN)
U1111-1257-2811
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attitudes of mental health professionals 318729 0
Post-traumatic stress disorder 319354 0
Condition category
Condition code
Mental Health 316733 316733 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318406 0
Behaviour
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.
Control group
Active

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")
Timepoint [1] 324900 0
Single timepoint, ranging from February 2020 to November 2020.
Secondary outcome [1] 386166 0
The predicted efficacy of the described treatment, measured on a 10-point likert scale.
Timepoint [1] 386166 0
Single timepoint, ranging from February 2020 to November 2020.
Secondary outcome [2] 386167 0
The likelihood of objecting to participating in the described treatment, measured on a 10-point likert scale.
Timepoint [2] 386167 0
Single timepoint, ranging from February 2020 to November 2020.
Secondary outcome [3] 386168 0
The likelihood that they would recommend participating in the described treatment, as measured by a 10 point likert scale.
Timepoint [3] 386168 0
Single timepoint, ranging from February 2020 to November 2020.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People under the age of 18.
People who do not work in Australia.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer software,
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/02/2020
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
2/11/2020
Actual
Sample size
Target
200
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306518 0
University
Name [1] 306518 0
University of Sydney, School of Psychology
Country [1] 306518 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 307051 0
None
Name [1] 307051 0
Address [1] 307051 0
Country [1] 307051 0
Other collaborator category [1] 281435 0
Individual
Name [1] 281435 0
Professor Nick Glozier
Address [1] 281435 0
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Country [1] 281435 0
Australia
Other collaborator category [2] 281436 0
Individual
Name [2] 281436 0
Associate Professor Ben Colagiuri
Address [2] 281436 0
Brain and Mind Centre, University of Sydney
94 Mallet St, Camperdown, NSW 2050
Country [2] 281436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306722 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306722 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 306722 0
Australia
Date submitted for ethics approval [1] 306722 0
Approval date [1] 306722 0
12/12/2019
Ethics approval number [1] 306722 0
2019/872

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104794 0
Prof Nick Glozier
Address 104794 0
Brain and Mind Centre, University of Sydney
94 Mallett St, Camperdown NSW 2050
Country 104794 0
Australia
Phone 104794 0
+61 2 9515 1596
Fax 104794 0
Email 104794 0
[email protected]
Contact person for public queries
Name 104795 0
Dr Dean Wright
Address 104795 0
Brain and Mind Centre, University of Sydney
94 Mallett St, Camperdown NSW 2050
Country 104795 0
Australia
Phone 104795 0
+61 2 9114 4343
Fax 104795 0
Email 104795 0
[email protected]
Contact person for scientific queries
Name 104796 0
Dr Dean Wright
Address 104796 0
Brain and Mind Centre, University of Sydney
94 Mallett St, Camperdown NSW 2050
Country 104796 0
Australia
Phone 104796 0
+61 2 9114 4343
Fax 104796 0
Email 104796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified responses to outcome variables, including demographic information.
When will data be available (start and end dates)?
Available after July 2021, until July 2026
Available to whom?
Scientific community
Available for what types of analyses?
Any analyses approved by a recognised ethics committee.
How or where can data be obtained?
via email to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8933Statistical analysis plan  [email protected]
8935Informed consent form  [email protected]
8936Clinical study report  [email protected] Available upon study completion and publication
8937Study protocol  [email protected]
8939Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the attitudes of mental health professionals towards trials of MDMA: a randomised vignette trial.2022https://dx.doi.org/10.1136/bmjopen-2021-060360
N.B. These documents automatically identified may not have been verified by the study sponsor.