Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth.

A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

ACTRN12624000776505.

V.2.3, 20 March 2025.

Patients with node-positive breast cancer having primary surgery currently undergo axillary node clearance (ANC) to reduce the risk of breast cancer recurrence. Evidence that this highly morbid procedure improves survival is lacking, but approximately 30% of patients will develop lifelong complications which significantly impact their quality of life.

Targeted axillary dissection (TAD) may be a safe, less morbid alternative to ANC and will be evaluated in the upcoming Targeted Axillary Dissection versus axillary node clearance in patients with POsitive axillary Lymph nodes in Early breast cancer (TADPOLE) randomised controlled trial.

TAD is not currently routine practice in patients having primary surgery, so it is vital that the procedure is performed in an agreed upon, standardised way within the trial and procedure fidelity monitored to ensure the results are generalisable and will be accepted by the surgical community. Robust surgical quality assurance (SQA) is essential. Here we describe the first phase of the TADPOLE SQA, a consensus process with the breast surgical community to agree upon how (1) surgery should be performed and standardised; (2) procedure fidelity will be monitored and (3) requirements for surgeon credentialling within the trial.

The consensus process will have three phases:

Ethical approval has been obtained from the University of Bristol Faculty of Health Sciences Ethics Committee. Educational materials including videos and webinars will be developed and shared with surgeons participating in TADPOLE. Results will be presented at national/international meetings and published in peer-reviewed journals.

Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial is the first study to consider psilocybin-assisted psychotherapy as a potential treatment for prolonged grief.

PARTING is an open-label pilot trial of psilocybin-assisted psychotherapy for approximately 15 people with cancer-related PGD. It aims to investigate feasibility, safety, acceptability, participant experience and participant-reported therapeutic effects. Over a 5-week intervention period, participants will undergo three preparation sessions before receiving a psychoactive (25 mg) dose of psilocybin alongside non-directive supportive guidance, followed by four integration sessions. All sessions will be delivered by a psychologist and either a nurse or Indigenous Therapist. An artificial intelligence-assisted tool will be used to create an artwork of participants’ psychedelic experience.

Outcomes will be investigated over a 12-month follow-up period. Feasibility will be assessed through recruitment/retention rates and completion of follow-up assessments. Safety will be evaluated via adverse events over 12 months and the comparison of physiological measures (vital signs, biochemistry, haematology, ECG) recorded during screening and 1 day after the psilocybin dose. Qualitative thematic analysis of semistructured interviews with participants and trial therapists will assess acceptability and the therapeutic potential of the treatment. Diagnostic clinical interviews for PGD and quantitative participant-reported measures of therapeutic effects are also being collected. Participant-reported measures include grief severity, depression, anxiety, grief avoidance, psychological flexibility, connectedness, and quality of life.

Ethics approval has been obtained from QIMR Berghofer Medical Research Institute Human Research Ethics Committee (P3801). Dissemination of results will occur via conference presentations, peer-reviewed publications and media.

Australian New Zealand Clinical Trials Registry (ACTRN12623000827639).