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Trial registered on ANZCTR
Registration number
ACTRN12624000871549
Ethics application status
Approved
Date submitted
23/05/2024
Date registered
16/07/2024
Date last updated
16/07/2024
Date data sharing statement initially provided
16/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study
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Scientific title
Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study
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Secondary ID [1]
312205
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
borderline personality disorder (BPD)
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post-traumatic stress disorder (PTSD)
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Condition category
Condition code
Mental Health
330559
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0
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
328652
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Treatment: Drugs
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Intervention code [2]
328759
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Treatment: Other
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Comparator / control treatment
The comparator participants will receive BPD-specific psychotherapy without the MDMA sessions.
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.
GPM is a therapeutic approach that helps patients with BPD manage their emotions and behaviours. It focuses on understanding how patients' hypersensitivity to relationship stressors impacts their emotions and behaviours.
GPM emphasizes the importance of relationships and how they can be a source of both stress and support. Therapists work with patients to identify and manage relationship stressors, improve communication skills, and build healthier relationships.
GPM incorporates practical tools and strategies such as problem-solving, education, and goal-setting to help patients manage their symptoms and improve their overall functioning
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Control group
Active
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Outcomes
Primary outcome [1]
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Safety
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Assessment method [1]
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Any adverse effects reported from the intervention will be recorded in a checklist that is specifically designed for this study.
Some of the reported risks associated with ingestion of MDMA include:
Rise in blood pressure (assessed using a digital sphygmomanometer) and/or heart rate (assessed using pulse oximeter)
Measurement of BP and HR at 1.5 to 2 hours after the initial dose, before the supplemental dose is administered
Elevated temperature
Measurement of temperature at 1.5 to 2 hours after the initial dose, before the supplemental dose is administered (assessed using a digital thermometer)
Hyponatremia
Recording the fluid intake (litre).
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Timepoint [1]
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Adverse events will be assessed at every session throughout the 6 to 12-month intervention
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Primary outcome [2]
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Feasibility from the perspectives of Spectrum clinicians
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Assessment method [2]
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We will assess feasibility from the perspectives of Spectrum clinicians using a study-specific survey.
For Spectrum clinicians, we will assess their impressions of clinical response and treatment engagement in participants, and sustainability of adding MDMA treatment to our psychotherapy program, with particular attention to staffing factors arising from the eight-hour treatment sessions.
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Timepoint [2]
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Feasibility will be assessed at every session throughout the 6 to 12-month intervention
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Primary outcome [3]
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Cost
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Assessment method [3]
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We will estimate the additional cost associated with providing MDMA-assisted treatment (medication, psychiatrist involvement, staffing additional treatment sessions/duration), and determine whether these costs are offset by (for example) a reduction in the duration of treatment required to achieve treatment goals that are comparable to longer psychotherapy-only treatments that Spectrum currently offers. Medication costs determined from MBS and staff costs will be determined from Spectrum records.
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Timepoint [3]
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At the end of the intervention when the treatment arm completed the treatment course
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Secondary outcome [1]
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State of mood
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Assessment method [1]
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Profile of Mood States (POMS) – short form
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Timepoint [1]
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Two month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [2]
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Dissociation
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Assessment method [2]
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Dissociative Experiences Scale (DES)
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Timepoint [2]
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Two month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [3]
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Dissociative symptoms
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Assessment method [3]
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Dissociative Subtype of PTSD Scale (DSPS)
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Timepoint [3]
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Two month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [4]
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DSM-5 criteria for PTSD
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Assessment method [4]
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Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)
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Timepoint [4]
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Admission and discharge
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Secondary outcome [5]
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Symptoms of PTSD
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Assessment method [5]
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PTSD checklist for DSM 5 (PCL-5)
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Timepoint [5]
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Admission and discharge; 3 and 6 months post-discharge
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Secondary outcome [6]
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Composite core features of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD)
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Assessment method [6]
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International Trauma Questionnaire (ITQ)
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Timepoint [6]
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Admission and discharge; 3 and 6 months post-discharge
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Secondary outcome [7]
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Borderline Symptoms
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Assessment method [7]
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Borderline Symptom List (BSL-23)
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Timepoint [7]
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Two-month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [8]
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Self-compassion
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Assessment method [8]
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Self-Compassion Scale (SCS)
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Timepoint [8]
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Two-month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [9]
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A composite measure for Suicidality/self-harm ideation/behaviours
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Assessment method [9]
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Covered in the BSL-23: Supplementary Behavioural Questions
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Timepoint [9]
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Two-month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [10]
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A composite measure for state guilt and shame
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Assessment method [10]
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Personal Feelings Questionnaire-2 (PFQ-2)
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Timepoint [10]
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Two-month intervals from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [11]
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Clinical review checklist completed by the principal therapist that includes a validated single-item psychiatric rating instrument for quantifying serial change during the course of clinical trials
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Assessment method [11]
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Clinical Global Impressions Scale (CGI)
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Timepoint [11]
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Fortnightly while engaged in treatment
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Secondary outcome [12]
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How participants' condition has changed
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Assessment method [12]
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Patients’ Global Impression of Change (PGI)
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Timepoint [12]
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Fortnightly while engaged in treatment
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Secondary outcome [13]
435415
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A composite measure assessing the three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond
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Assessment method [13]
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Working Alliance Inventory- Short Form (WAI-SF)
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Timepoint [13]
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Monthly while engaged in treatment
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Secondary outcome [14]
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Clinical supervisors' perceptions of therapist countertransference behaviour in a given session
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Assessment method [14]
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Inventory of Countertransference Behavior (ICB)
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Timepoint [14]
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Following MDMA sessions
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Secondary outcome [15]
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Quality of life of people with different mental health conditions, focusing on the process of recovery for people using mental health services
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Assessment method [15]
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Recovering Quality of Life Questionnaire (ReQoL-10)
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Timepoint [15]
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Monthly from admission to discharge; 3 and 6 months post-discharge
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Secondary outcome [16]
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Acceptability of a healthcare intervention
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Assessment method [16]
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Theoretical Framework of Acceptability (TFA)
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Timepoint [16]
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Monthly while engaged in treatment (and after MDMA sessions)
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Secondary outcome [17]
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Suicidality
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Assessment method [17]
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Columbia Suicide Severity Rating Scale (C-SSRS) Self Report – Since Last Visit
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Timepoint [17]
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Monthly while engaged in treatment (and after MDMA sessions)
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Secondary outcome [18]
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Treatment Engagement
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Assessment method [18]
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Treatment Engagement Rating Scale (TER)
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Timepoint [18]
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Monthly while engaged in treatment
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Secondary outcome [19]
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Acute psychologically insightful experiences that may occur during exposure to psychedelic medication
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Assessment method [19]
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Psychological Insight Questionnaire (PIQ)
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Timepoint [19]
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Following MDMA sessions
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Secondary outcome [20]
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Feasibility from the perspectives of Spectrum clients (This is a primary outcome)
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Assessment method [20]
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We will assess feasibility from the perspectives of Spectrum clients using the study records.
For clients, we will record the proportion of eligible clients who accepted the invitation to participate in MDMA-assisted psychotherapy, proportion of participants who commenced/completed the intervention, proportion completing the follow-up evaluation, and attrition rates throughout.
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Timepoint [20]
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Feasibility will be assessed at every session throughout the 6 to 12-month intervention
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/07/2024
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Actual
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Date of last participant enrolment
Anticipated
25/07/2025
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Actual
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Date of last data collection
Anticipated
26/06/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
42612
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3121 - Richmond
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Spectrum Personality Disorder Service for Victoria
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Spectrum Personality Disorder Service for Victoria
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318761
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Country [1]
318761
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315369
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Eastern Health Human Research Ethics Committee
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Ethics committee address [1]
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https://www.easternhealth.org.au/site/item/34-research-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/11/2023
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Approval date [1]
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27/03/2024
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Ethics approval number [1]
315369
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E23-013-102057
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Sathya Rao
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Address
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Spectrum - Personality Disorder and Complex Trauma Service, Eastern Health, 110 Church Street, Richmond, VIC 3121
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Country
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Australia
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Phone
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+61 417560979
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Jillian Broadbear
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Address
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Spectrum - Personality Disorder and Complex Trauma Service, Eastern Health, 110 Church Street, Richmond, VIC 3121
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Country
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Australia
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Phone
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+61 3 8413 8674
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Jillian Broadbear
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Address
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Spectrum - Personality Disorder and Complex Trauma Service, Eastern Health, 110 Church Street, Richmond, VIC 3121
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Country
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Australia
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Phone
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+61 3 8413 8674
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The whole psychotherapy will be tape-recorded, so the researchers have decided to make the data confidential at this stage.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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