None listed
Conditions
Brief summary
Traumatic experiences and consequent development of trauma disorder (PTSD, complex-PTSD) frequently occurs in people diagnosed with borderline personality disorder (BPD). The only evidence-based treatment for BPD is psychotherapy, however this does not directly address the impact of trauma disorder which reduces the likelihood of achieving remission and recovery. The recent decision of the TGA to approve the prescription of 3,4-methylenedioxy-methamphetamine (MDMA) as an adjunct to psychotherapy represents a break-through that could dramatically improving treatment outcomes for BPD and post-traumatic stress disorder (PTSD or Complex-PTSD) when they co-occur. Spectrum is a specialist public mental health service that provides treatment for people experiencing severe, complex, and high-risk clinical presentations of BPD and trauma throughout Victoria. In this pilot study, we will conduct a controlled before and after pilot study to assess the feasibility and acceptability of offering MDMA-assisted psychotherapy in our specialist public mental health service. Given that the efficacy and safety of MDMA for the treatment of PTSD has already been established, our study will assess efficacy, safety, and cost-effectiveness as secondary outcomes. MDMA will be administered within an evidence-based psychotherapy program. The pilot study will entail recruiting participants diagnosed with PTSD (or C-PTSD) and co-occurring BPD. There are two arms in the study. In the first, six to eight participants will receive psychotherapy + MDMA while in the second arm, six to eight matched participants will receive psychotherapy only. A wide range of assessment and evaluation measures will be used, utilising quantitative and qualitative approaches to examine clinician assessed and participant self-reported outcomes.
Interventions
A treatment that combines BPD-specific psychotherapy and 3,4-Methylenedioxymethamphetamine (MDMA) within the public mental health sector.
The initial recruitment effort will focus on identifying participants for the MDMA treatment arm. Once MDMA treatment arm participants have commenced treatment, recruitment will target psychotherapy-only participants who will be matched on sex, age (within 2 years), education, and similarity in clinical presentation. The comparator participants will receive
A treatment that combines BPD-specific psychotherapy and 3,4-Methylenedioxymethamphetamine (MDMA) within the public mental health sector. The initial recruitment effort will focus on identifying participants for the MDMA treatment arm. Once MDMA treatment arm participants have commenced treatment, recruitment will target psychotherapy-only participants who will be matched on sex, age (within 2 years), education, and similarity in clinical presentation. The comparator participants will receive the same psychological treatment without the MDMA sessions. Following comprehensive assessment, all participants will participate in a pre-treatment module. This comprises one-hour individual psychotherapy sessions each week for six weeks which provide psychoeducation about PTSD and BPD, describe the course of treatment, role of the clinician, expectations of participants, likely challenges that will arise, co-development of treatment and crisis plans, and (if they are in the MDMA arm) preparatory sessions prior to the first administration of MDMA. The psychotherapy approach that will be used is ‘Good’ or ‘General Psychiatric Management’ (GPM), which has been shown in a large randomized control trial to be as efficacious as Dialectical Behavior Therapy (DBT) across different outcomes such as reducing symptomatic distress, suicidal behaviour, utilisation of disability benefits, and overall BPD pathology. This generalist psychotherapy approach to managing BPD is able to be individualised and is flexible in its application for patients who experience severe presentations of BPD. For participants in the MDMA arm, between two and five MDMA sessions will be offered during a six-month course of GPM-Complex with at least one-month intervals between the sessions. According to the patient's response to MDMA and the psychiatrist's clinical judgement, the psychiatrist will decide on the number of MDMA sessions (two, three, four or five sessions). MDMA treatment sessions will last for up to eight hours. The starting dose for the first session will be 80mg, with a possible additional dose of 40mg as clinically indicated. Depending on each participant’s response to MDMA, the dosing schedule may vary in subsequent sessions. Blood pressure and heart rate will be measured at 1.5 to 2 hours after the initial dose. A session checklist will be used to record the adherence to the intervention components. MDMA treatment sessions will take place in a dedicated space staffed with two therapists – one male and one female. One will be the principal therapist (a psychiatrist) who will prescribe the MDMA, and the other will be the co-therapist, an experienced DBT clinician. Both will be familiar to participants from previous treatment sessions. Informed consent will be requested prior to each MDMA session. MDMA in the form of an oral tablet will be administered at the beginning of the session. All sessions will be videotaped for review (if required) in case of conflict resolution or clinical supervision. The content of MDMA sessions will be guided by the participant rather than directed by the therapist. Therapists will provide an empathetic, safe, and validating environment to assist the participant in processing traumatic experiences. Therapists are able to provide more active support as needed. Post-MDMA treatment sessions will continue weekly, focusing on integration of experiences arising from the MDMA session(s) using a GPM-Complex approach. The integration process helps the participant with meaning-making, creating awareness, and translating insights that the participant experienced during the MDMA treatment session. The comparator group will continue receiving one-hour weekly GPM-Complex sessions for six months. Apart from the integration sessions, the structure and content of GPM-Complex will be similar for participants in both treatment arms. The key study outcomes will be evaluated during and after six months for participants in both arms. Some evaluation instruments will be completed again at three and six months’ post-discharge. In the case that participants continue in treatment for an additional six months (DBT psychotherapy will be offered if clinically indicated), outcomes will continue to be measured after three and six months of DBT and then at three and six months’ post-treatment. If at the end of six-month study period, further treatment is indicated for participants in either treatment arm, they will be offered an additional six months of dialectical behavior therapy (DBT) – the most widely used specialist manualised treatment for BPD. As a specialist public mental health service, Spectrum’s purpose is to support clients to meet their treatment goals. This usually entails achieving clinical remission from symptoms of BPD. Two of Spectrum’s doctors (psychiatrists) have completed the specialist MDMA training (MAPS19) and have appropriate qualifications to prescribe MDMA. Several female DBT-trained Spectrum clinicians will be trained in-house to assist the study doctors with the MDMA psychological treatment sessions as co-therapists will be present for the pre-MDMA preparation sessions, during MDMA treatment days, at post-MDMA integration sessions, and available to facilitating regular psychotherapy sessions when the study doctors are unavailable. If required, the co-therapists will also facilitate the additional six months of psychological treatment using DBT once the 6 month study period has ended. Spectrum’s medical team will conduct all clinical assessments. Spectrum’s research team (led by study investigator) will oversee completion of the evaluation measures.
Sponsors
Spectrum Personality Disorder Service for Victoria
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
• Female clients aged 18 years or older who are eligible for treatment from Spectrum’s Complex Care Team (reserved for clients with severe and high risk presentations for whom manualised specialised treatment programs are not indicated) • Diagnosis of PTSD (or Complex PTSD) • Diagnosis of BPD • Effective method of contraception if of child-bearing age • Fluent in written and spoken English language
Exclusion criteria
• Diagnosis of Narcissistic or Antisocial Personality Disorder (which lack the attachment pathology we believe is amenable to the actions of MDMA) • Diagnosis or likely diagnosis of Autism Spectrum Disorder or traits • Currently taking prescription medication for attention deficit hyperactivity disorder (ADHD) • Intellectual disability severe enough to affect the provision of informed consent and preclude engagement in psychological treatment programs • Serious medical illness (particularly those affecting the cardiovascular system) • Pregnant or breast-feeding • Medication prescribed to treat psychiatric symptoms. Contraindicated substances and medications include MDMA metabolites or analogues, anaesthetics, muscle relaxants, amphetamines and stimulants, benzodiazepines, ethanol, opioids, antidepressants (e.g. bupropion, sertraline, venlafaxine, moclobemide, and citalopram), olanzapine and any medication that increases the concentration of serotonin. Study participation will require cessation of these medications prior to commencing the study.22 In practice, a washout period will be required, generally two weeks for most psychotropic medications. The tapering and ceasing will only be initiated when a MDMA dosing date is determined and then the tapering start will be backdated from this. It is possible that a participant's symptoms will worsen during this tapering and ceasing phase. Cessation of medication will be carried out under clinical supervision where it is considered safe to do so. The decision to cease medications will be for the participant and their usual treating practitioner to determine.
Outcome results
None listed