Effect of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer (EMMAC): study protocol for a double-blind, randomised controlled trial.

BACKGROUND: Symptoms of anxiety and depression are common in patients with terminal illness and multiple challenges exist with timely and effective care in this population. Several centres have reported that one dose of the serotonergic psychedelic psilocybin, combined with therapeutic support, improves these symptoms for up to 6 months in this patient group. Drawing upon related therapeutic mechanisms, 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy may have the potential to achieve similar, positive mental health outcomes in this group. Preliminary evidence also supports the tolerability of MDMA-assisted therapy for anxiety and depression in advanced-stage cancer. METHODS: Up to 32 participants with advanced-stage cancer and associated depression and anxiety will be randomised in a 1:1 ratio into one of two blinded parallel treatment arms. The intervention group will receive 120 mg (+ 60 mg optional supplemental dose) MDMA-assisted therapy. The psychoactive control group will receive 20 mg oral (+ 10 mg optional supplemental dose) methylphenidate-assisted therapy. For each medication-assisted therapy session, participants will undergo two 90-min therapeutic support sessions in the week preceding, and one 90-min support session the day after the experimental session. A battery of measures (mood, anxiety, quality of life, mystical experience, spiritual wellbeing, attitudes towards death, personality traits, holistic health and wellbeing, connectedness, demoralisation, expectations, qualitative data and safety measures) will be assessed at baseline and through to the end of the protocol. Participants will be followed up until either 12 months post-randomisation or death, whichever occurs first. DISCUSSION: This study will examine the effect of MDMA-assisted therapy on symptoms of anxiety and depression in advanced-stage cancer. Potential therapeutic implications include establishing the safety and effectiveness of a novel treatment that may relieve mental suffering in patients with life-threatening illness. TRIAL REGISTRATION: Trial registered on Australian New Zealand Clinical Trials Registry. REGISTRATION NUMBER: ACTRN12619001334190p. Date registered: 30/09/2019. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true.

The lived experience of chronic pain for Maori: how can this inform service delivery and clinical practice? A systematic review and qualitative synthesis.

AIM: To synthesise the literature describing experiences of chronic pain and pain management for Maori, and to understand how this experience could inform service delivery and clinical practice. METHOD: We systematically searched for qualitative research on Maori chronic pain experiences (Scopus, Medline, APA PsycINFO, NZ Research, Research Square). Data extracted were coded and synthesised using thematic analysis. RESULTS: Seven studies were included. Three themes encapsulated the data: 1) a multidimensional view of pain and pain management: Maori expressed a holistic and integrated understanding of the multiple factors that influence pain and its management, 2) a responsibility: respectful tikanga-informed care: the experiences of Maori participants with healthcare highlight a need for antiracist approaches, and a clinical responsibility to practice manaakitanga and tikanga, and 3) tino rangatiratanga: a desire for knowledge, choice and autonomy in pain management: Maori valued the empowering nature of knowledge about pain, and information and support to make decisions about treatment, including considerations regarding Western and traditional Maori medicine. CONCLUSION: Health services need to understand and respect the multidimensional aspects of pain, minimise racism and discrimination, use whakawhanaungatanga, manaakitanga, and tikanga-informed practices, and provide appropriate information to support tino rangatiratanga for pain management.

PAM trial protocol: a randomised feasibility study of psychedelic microdosing-assisted meaning-centred psychotherapy in advanced stage cancer patients.

BACKGROUND: An advanced cancer diagnosis can be associated with a significant profile of distress. Psychedelic compounds have shown clinically significant effects in the treatment of psychological distress in patients with advanced-stage cancer. Given the challenges of delivering timely and effective intervention in the advanced cancer context, it is possible that an alternative, more pragmatic, approach lies in psychedelic 'microdosing'. Microdosing refers to repeated administration of psychedelics in sub-hallucinogenic doses. The purpose of this study is to evaluate the feasibility of conducting a full-scale randomised controlled trial comparing psychedelic microdose-assisted-meaning-centred psychotherapy (PA-MCP) to standard meaning-centred psychotherapy (MCP) in New Zealand indigenous (Maori) and non-indigenous people with advanced cancer and symptoms of anxiety and/or depression. Although MCP is a well-established psychotherapeutic treatment in advanced cancer populations, the potential efficacy and effectiveness of this therapy when delivered alongside a standardised microdose regimen of a psychedelic compound have not been investigated. METHODS: Participants with advanced-stage cancer and symptoms of anxiety and/or depression (N = 40; 20 Maori, 20 non-Maori) will be randomised under double-blind conditions to receive 7 sessions of MCP alongside 13 doses of either an LSD microdose (4-20 µg) (PA-MCP) or inactive placebo (placebo-MCP). The feasibility, acceptability, and safety of this intervention and physiological and psychological measures will be recorded at baseline, at each session of MCP, and at a 1-month and 6-month follow-up. DISCUSSION: Our findings will evaluate the feasibility, acceptability, and safety of a larger randomised controlled trial and provide an initial indication of the potential benefits of psychedelic microdosing for psychological distress in advanced-stage indigenous and non-indigenous cancer patients. TRIAL REGISTRATION: NZCTR, ACTRN12623000478617. Registered 11 May 2023.  https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385810&isReview=true .

The perceptions of cancer health-care practitioners in New Zealand and the USA toward psychedelic-assisted therapy with cancer patients: A cross-sectional survey.

OBJECTIVES: A resurgence of research investigating the administration of psychedelic compounds alongside psychotherapy suggests that this treatment is a promising intervention for anxiety, depression, and existential distress in people with cancer. However, psychedelic treatment that induces a mind-altering experience potentially poses barriers to vulnerable cancer patients, and health-care practitioners may have concerns about referring their patients to trials investigating this approach. The aim of the current study was to investigate the perceptions of cancer health-care practitioners based in New Zealand and the USA related to psychedelic-assisted therapy. METHODS: This study utilized a cross-sectional survey of cancer health-care practitioners in New Zealand and the USA via convenience sampling to identify their perceptions about the concept of conducting psychedelic-assisted therapy with cancer patients. RESULTS: Participants perceived that (1) psychedelic-assisted therapy has the potential to provide benefit for cancer patients, (2) research in this area across a variety of domains is important, (3) work should consider spiritual and indigenous perspectives of health, and (4) there was willingness to refer patients to trials in this area, especially patients with advanced disease who were no longer going through curative treatment. Participants in the USA had greater awareness of psychedelics than the New Zealand sample; however, New Zealand participants more strongly believed that spiritual/indigenous factors should be considered in psychedelic-assisted therapy. SIGNIFICANCE OF RESULTS: Cancer health-care practitioners in our sample considered research investigating the potential for psychedelic-assisted therapies to be important and may be more open to studies that start in palliative and end-of-life contexts.

Illness perceptions and diabetes self-care behaviours in Maori and New Zealand Europeans with type 2 diabetes mellitus: a cross-sectional study.

AIMS: This study investigated differences in illness perceptions and self-care behaviours between Maori and New Zealand (NZ) Europeans with type 2 diabetes mellitus (T2DM), and how these perceptions were related to clinical outcomes. METHODS: Participants were 85 Maori and 85 NZ European adults, recruited from outpatient clinics, who completed a cross-sectional questionnaire on illness perceptions and self-care behaviours. Clinical data, including HbA1c, retinopathy, neuropathy and nephropathy, were collected from medical records. RESULTS: Compared to NZ Europeans, Maori had higher HbA1c, lower adherence to medication and a healthy diet, and were more likely to smoke. Maori reported greater perceived consequences of diabetes on their lives, and more severe symptoms than NZ Europeans did. Maori were more likely to attribute T2DM to food and drink, whereas NZ Europeans were more likely to attribute T2DM to weight. Perceiving that treatment could help control diabetes was associated with lower HbA1c and higher medication adherence in Maori and NZ Europeans independently. CONCLUSIONS: Maori experienced and perceived worse T2DM outcomes than NZ Europeans did. Research is needed to develop and test clinical interventions to address these inequities and improve outcomes, possibly by asking patients about their perceptions, providing tailored and culturally appropriate education, and discussing patients' concerns.

Well-being app to support young people during the COVID-19 pandemic: randomised controlled trial.

OBJECTIVES: To evaluate the efficacy and acceptability of 'Whitu: seven ways in seven days', a well-being application (app) for young people. DESIGN: Prospective randomised controlled trial of Whitu against waitlist control, with 45 participants in each arm. PARTICIPANTS: 90 New Zealand young people aged 16-30 recruited via a social media advertising campaign. SETTING: Participants' homes. INTERVENTIONS: Developed during the COVID-19 pandemic, and refined from a prototype version that was evaluated during a smaller qualitative study, 'Whitu: seven ways in seven days' is a well-being app that, as its name suggests, contains seven modules to help young people (1) recognise and rate emotions, (2) learn relaxation and mindfulness, (3) practice self-compassion and (4) gratitude, (5) connect with others, (6) care for their physical health and (7) engage in goal-setting. It can be completed within a week or as desired. MAIN OUTCOME MEASURES: Primary outcomes were changes in well-being on the WHO 5-item Well-Being Index and Short Warwick-Edinburgh Mental Well-Being Scale. Secondary outcomes were changes in depression on the Centre for Epidemiological Studies Depression Scale, anxiety on the Generalised Anxiety Disorder 7-item Scale, self-compassion on the Self Compassion Scale-Short Form, stress on the 10-item Perceived Stress Scale, sleep on the single-item Sleep Quality Scale and user engagement on the end-user version of the Mobile Application Rating Scale and via qualitative feedback during an online survey. Outcomes were evaluated at baseline, 4 weeks (primary study endpoint) and 3 months, and analysed using linear mixed models with group, time and a group-time interaction. RESULTS: At 4 weeks, participants in the Whitu group experienced significantly higher emotional (Mean difference (md) 13.19 (3.96 to 22.42); p=0.005) and mental (md 2.44 (0.27 to 4.61); p=0.027) well-being, self-compassion (md 0.56 (0.28 to 0.83); p<0.001) and sleep (md 1.13 (0.24 to 2.02); p=0.018), and significantly lower stress (md -4.69 (-7.61 to -1.76); p=0.002) and depression (md -5.34 (-10.14 to -0.53); p=0.030), compared with the waitlist controls. Group differences remained statistically significant at 3 months for all outcomes. Symptoms of anxiety were also lower in the intervention group at 4 weeks (p=0.096), with statistically significant differences at 3 months (md -2.31 (-4.54 to -0.08); p=0.042). Usability of Whitu was high (subjective ratings of 4.45 (0.72) and 4.38 (0.79) out of 5 at 4 weeks and 3 months, respectively) and qualitative feedback indicated individual and cultural acceptability of the app. CONCLUSIONS: Given the evolving psychological burden of the COVID-19 pandemic, Whitu could provide a clinically effective and scalable means of improving the well-being, mental health and resilience of young people. Replication of current findings with younger individuals and in other settings is planned. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620000516987).

Pilot study of a well-being app to support New Zealand young people during the COVID-19 pandemic.

BACKGROUND: Well-being apps represent a promising and scalable approach for improving mental health outcomes in youth, especially during a global pandemic when access to face-to-face interventions may be limited. Whitu (meaning 7 in the New Zealand Maori language Te Reo) is a newly developed well-being app with 7 modules that support young people to learn and practice evidence-based coping skills, including relaxation, mindfulness, self-compassion, and goal-setting. OBJECTIVE: During this pilot, we explored the acceptability, usability, and preliminary efficacy of Whitu before refining the app for a randomized controlled trial (RCT). METHODS: We recruited 20 New Zealand young people aged 16-25 years via social media to trial the first prototype of the Whitu app over 6 weeks. Within-group differences from baseline to 2- and 6-weeks post intervention in self-reported well-being, depression, anxiety, stress, self-compassion, optimism and sleep quality were evaluated using repeated-measures ANOVA. A further 21 participants aged 16-30 years were recruited to participate in 4 focus groups to give feedback on the app's usability and cultural acceptability. Feedback was analysed using directed content analysis. RESULTS: Statistically significant improvements in anxiety (p = 0.024) and stress (p = 0.017) were observed from baseline to 2-weeks post intervention. Improvements in well-being (p = 0.021), depression (p = 0.031), anxiety (p = 0.005), and stress (p = 0.004) were also observed from baseline to 6-weeks. No statistically significant changes were seen in self-compassion, optimism, or sleep quality. Effect sizes (partial η2s) ranged from 0.25 (depression) to 0.42 (stress). Qualitative feedback comprised of five key themes, namely: factors affecting engagement, issues with functionality, preferences regarding aesthetics, effectiveness and adverse effects, and cultural acceptability. CONCLUSIONS: Our preliminary results suggest that Whitu may be an effective app for improving multiple dimensions of young people's well-being. Modifications to the look and feel, cultural content, and onboarding have been undertaken based on the qualitative feedback, and an RCT is currently underway.

Coping Skills Mobile App to Support the Emotional Well-Being of Young People During the COVID-19 Pandemic: Protocol for a Mixed Methods Study.

BACKGROUND: The COVID-19 pandemic is likely to increase anxiety and distress in young people worldwide. It is important to prioritize mental health during crisis events to mitigate the negative and often long-term effects of the crises on young people, families, and society. Mental health and well-being apps represent a scalable approach for improving psychological outcomes in young people and have potential to improve the equity of service access. OBJECTIVE: The Whitu: 7 Ways in 7 Days well-being app was recently developed by our group to address the urgent need for innovative approaches to reach young New Zealanders who are struggling to cope with the COVID-19 pandemic. The aim of this study is twofold: to evaluate the acceptability of the prototype app and to examine the effectiveness of the refined app at improving mental and emotional well-being and reducing depression, anxiety, and stress in young people in New Zealand. METHODS: A two-phase mixed methods study will be undertaken to achieve these aims. During the first phase, 20 young people aged 16-30 years (including those of Maori and Pacific ethnicity) will participate in a qualitative study to help refine the prototype app. During the second phase, 90 young people aged 16-30 years will participate in a randomized waitlist-controlled trial (RCT) to evaluate the efficacy of the refined Whitu app at 4 weeks and 3 months after baseline. Outcomes will be evaluated using validated web-based questionnaires at baseline, 4 weeks, and 3 months. RESULTS: The study received ethics approval in May 2020, and recruitment for the focus groups commenced in June 2020. Recruitment for the RCT is expected to commence in October 2020. Participants for both study phases will be recruited via social media and web-based communities. Data collection for the RCT is expected to be completed by January 2021, and analyses are expected to be completed by March 2021. Linear mixed modelling will be used to determine between-group differences in psychological outcomes. CONCLUSIONS: There is an urgent need to develop culturally appropriate, scalable mental health interventions to address the psychological consequences of the COVID-19 pandemic. In this study, we will develop and test an evidence-based well-being app that, if effective, can be made available to all young people in New Zealand and internationally. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12620000516987); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379597. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/23716.

Differences in patients' perceptions of Schizophrenia between Maori and New Zealand Europeans.

OBJECTIVE: Maori (the Indigenous people of New Zealand) are disproportionately affected by mental illness and experience significantly poorer mental health compared to New Zealand Europeans. It is important to understand cultural differences in patients' ideas about mental illness in treatment settings. The aim of the present study was to investigate differences in illness perceptions between Maori and New Zealand Europeans diagnosed with schizophrenia. METHOD: A total of 111 users of mental health services (68 Maori, 43 New Zealand European) in the greater Auckland and Northland areas who had been diagnosed with schizophrenia or other psychotic disorder were interviewed using the Brief Illness Perception Questionnaire and the Drug Attitude Inventory. District Health Board staff completed the Global Assessment of Functioning for each patient. RESULTS: Maori with schizophrenia believed that their illness would continue significantly less time than New Zealand European patients did. Chance or spiritual factors were listed as causes of mental illness by only five Maori patients and no New Zealand European patients. Other illness perceptions, as well as attitudes towards medication, were comparable between groups. Across groups, the top perceived causes were drugs/alcohol, family relationships/abuse, and biological causes. CONCLUSION: Illness perceptions provide a framework to assess patients' beliefs about their mental illness. Differences between Maori and New Zealand European patients' beliefs about their mental illness may be related to traditional Maori beliefs about mental illness. Knowledge of differences in illness perceptions provides an opportunity to design effective clinical interventions for both Maori and New Zealand Europeans.