RecruitingACTRN12620001068954

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


Sponsor

University of Sydney

Enrollment

200 participants

Start Date

Feb 11, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study explores how mental health professionals — psychologists, psychiatrists, and mental health researchers — feel about a relatively new treatment for post-traumatic stress disorder (PTSD) involving MDMA-assisted therapy. PTSD can be a debilitating condition, and while MDMA-therapy has shown promise in clinical trials, there are concerns that professionals may have biases about it due to the drug's recreational history. To test this, participants will be randomly shown one of two scenarios describing the same treatment approach: one labelled as MDMA-therapy and one described with a neutral name. They'll then answer questions about their perceived safety concerns, predicted effectiveness, and willingness to recommend the treatment. This clever design helps reveal whether the name of the substance — not the actual science — is shaping professional attitudes. You are eligible to participate if you currently work in Australia as a registered psychologist, psychiatrist, or mental health researcher registered with AHPRA, and you are 18 years of age or older. People who do not work in Australia or are under 18 are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 co

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12620001068954