Developing Optimal Psychedelic Assisted Psychotherapy for Obsessive-Compulsive Disorder

MDMA + Psychotherapy: Session plan – minimum of 2 preparation sessions, 3 MDMA sessions (2-6 weeks apart), 4 integration sessions, for example: Week 1 Preparation session 1 Week 2 Preparation session 2 Week 3 MDMA 1 + integration session 1 Week 4 Preparation session 3 (optional) Week 5 MDMA 2 + Integration session 2 Week 6 Preparation session 4 (optional) Week 7 MDMA 3 + Integration session 3 Week 8 Integration session 4 The therapists conducting these sessions are health/healing professionals (doctor, psychiatrist, psychologist, psychotherapist, counsellor, nurse) trained in the administration of psychedelic assisted psychotherapy. Adherence will be recorded electronically through a session attendance checklists as part of their study file. Overview of 2 x preparation sessions for MDMA: There will be a minimum of two 90-minute preparation sessions conducted remotely or in person with a therapist. There also will be an opportunity for participants to engage in an optional preparation session prior to the second and third medication session. The participant will have the opportunity to meet the therapists/staff who will be present in the MDMA dosing session prior to dosing, during this preparation phase (more preparation sessions will be provided if deemed necessary by the therapist). Preparation session 1: Alliance development and formulation: the primary aims of the initial session will be the development of a therapeutic alliance, build trust and safety between the study therapists and the participant. Clarify participant intentions for the MDMA session, anxieties and hopes for the experience. Discuss ethical considerations and participant choices around use of touch, grounding techniques, and preferences such as music playlist, utilising eye mask, what will happen in the MDMA session, expectations and concerns and previous experience, media awareness or knowledge of psychedelic therapy. Inform them about what to expect during the MDMA sessions, psychological and physiological effects, who will be present, and the integration process. Preparing social support and integration for after the dosing session. Support person should be informed of the nature of the study. Gain an understanding of participant’s obsessional thoughts and associated avoidance, rituals or compulsive behaviours, and the situations which act as triggers for them. Eliciting and defining the range of OCD thoughts and behaviours via a thorough symptom review, using the Yale-Brown Obsessive Compulsive Scale (YBOCS). Between session task: Participant completes an OCD self-monitoring worksheet (this will take no more than 5 minutes per day to complete). Preparation Session 2: Therapist/s continue to build trust and rapport with participant. Participant meets one or two of the therapists who will be present during the dosing session. Review self-monitoring sheet and further clarify intentions, including exposure hierarchy, for the MDMA session. Psychoeducation around OCD, and the role of avoidance in maintaining OCD. Goals are developed collaboratively between the therapists and the participant, based around anxiety provoking situations of increasing difficulty during MDMA sessions. Discuss common experiences in MDMA session including transpersonal, spiritual aspects and approaching difficult and intense experiences. Information on non-ordinary states of consciousness, preparing to be open and curious in observing what arises. Practical guidance and safety instructions, including departure requirements. Optional Preparation Session 3: Occurs after the first MDMA session, and before the second MDMA session. Review intentions for the second MDMA session flexibly, as these may have changed since the first MDMA session. Building upon the first integration session, reflect on insights gained. Where applicable, collaboratively review psychotherapeutic tools and goals. Overview of dosing sessions: The medication sessions will be conducted at Monarch Mental Health Group (MMHG) clinical facilities in Sydney and Melbourne. There will be three dosing sessions conducted between 2 and 6 weeks apart. A single dose of 100mg MDMA in an oral capsule will be administered by a medical practitioner or nurse to the participant. Each session will last up to 8 hours and will be conducted with each individual participant separately. Prior to the participant’s arrival, the room will be prepared such that it provides a safe, warm, private atmosphere with the provision for music, eye shades, gentle lighting, and the ability for the participant to lie down with an appropriate blanket and pillow. Overview of 4 x MDMA integration sessions: The participant will be engaged in a 90-minute debriefing / integration session within 72 hours after each medication session. These may be conducted in person or remotely. The purpose of the debriefing / integration sessions is to support the participant in their ability to reflect on the medication sessions and to help them to make meaning and clarify insights that may have been developed using psychotherapeutic tools. Integration session 1: Occurs within a week after the first dosing. Participant and therapist reflect on insights gained in the first dosing; any new adaptive information gained. Psychotherapy processes conducted. Create space to discuss new concerns which may emerge in the medicine session, normalise experience and begin to establish intentions for the next MDMA session. Integration session 2: Occurs within a week after the second dosing. As above, participant and therapist reflect on insights gained in the second dosing; any new adaptive information gained.Psychotherapy processes conducted. Create space to discuss new concerns which may emerge in the medicine session, normalise experience and begin to establish intentions for the third and final MDMA session. Integration session 3: Occurs within a week after the third dosing. As above, participant and therapist reflect on insights gained in the first dosing; any new adaptive information gained. Psychotherapy processes conducted. Preparation for the end of the trial and plan for ongoing support and aftercare. Integration session 4: Occurs 2 weeks after the last dosing session. Final session with study therapists and participant together, focused on consolidating insights and gains, review progress with psychotherapeutic tools and relapse prevention strategies. Values work. Importantly, the therapists acknowledge participant’s hard work, and provide warm handovers for any outstanding concerns. Identify any new goals in recovery. Explore barriers to accessing ongoing support and address same. Potential to bring in a family member or loved one for support with their plan for ongoing recovery. EEG Component: A subset of participants will also undergo an electroencephalogram (EEG) recording session on three occasions: at baseline, and following the first and third drug session. These recordings will be conducted by trained research staff. Please note, the subset of participants receiving EEG recordings will be determined by equipment availability.