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Evaluating mental health professional attitudes of a new treatment for post-traumatic stress disorder (PTSD)

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001068954
Enrollment
100
Registered
2020-10-16
Start date
2020-02-11
Completion date
2020-11-01
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 tr

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants must be working within Australia as a psychologist, psychiatrist or mental health researcher. Psychologists and psychiatrists must be registered with AHPRA.

Exclusion criteria

People under the age of 18. People who do not work in Australia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026