RESULTS from a recent study conducted by the authors suggest that mental disorders are the most common illness among Aboriginal and Torres Strait Islander peoples (herein respectfully referred to as Indigenous Australians). Despite this, no robust evidence regarding efficacious and culturally acceptable treatments for mental health disorders currently exist.

For Indigenous Australians, the role of good mental health and wellbeing is grounded in holistic concepts of social and emotional wellbeing. This concept, which recognises the importance of land, culture, spirituality, ancestry, family and community, is paramount to the understanding of mental health for Indigenous peoples. Therefore, a model of care for the mental health of Indigenous Australians that is designed and developed in collaboration with Indigenous communities, embedding social and emotional wellbeing concepts alongside traditional western models of treatment or therapy, is fundamental for the successful implementation and treatment of any mental health disorders.

Considering the safety and health of Indigenous communities, we must take precautions to mitigate the exposure of Indigenous communities to COVID-19. The effects of COVID-19 on the continuation of critical research trials has created a challenging scenario for researchers. Particularly, for high risk and vulnerable populations, the decision to suspend or modify ongoing research activities is a dilemma not experienced before. Research teams across Australia have been asked to consider what “critical research” is and what plans can be put in place to protect the health and safety of researchers and, more importantly, their participants. With a national response to COVID-19 and a pandemic preparedness management plan in place for Indigenous Australians, now more than ever, it is essential to engage and work with Indigenous Australians and communities to develop culturally appropriate research contingency plans to continue already established research. We share our experiences and lessons learnt below in the hope that other similar research can benefit from these experiences in the current new and evolving research environment.

Funded by a National Health and Medical Research Council (NHMRC) of Australia Global Alliance for Chronic Diseases grant (GNT1144765), this research team is in the process of evaluating an innovative, culturally acceptable Indigenous Model of Mental Health Care (IMMHC) through a randomised controlled trial (RCT) (ANZCTRN12618001746224). The RCT ensures the evidence from the study is robust and reliable. This trial and the treatment approaches were designed with and led by community through extensive consultation and participatory research approaches. A description of the trial is provided in a study protocol by Toombs and colleagues (2020). Briefly, the trial will implement a model of mental health care developed by the Indigenous community and based on cognitive behavioural therapy, and will determine if the IMMHC is more effective than treatment as usual in Indigenous patients diagnosed with depression.

The IMMHC has had serious implications to consider because of the requirements to meet current guidance from the NHMRC on clinical trials. Although this document provides a thorough overview of general guidelines for public health and other researchers, it does not explicitly explain logistical and practical approaches for our trial. Understandably, every research project, as well as every researcher, would be navigating new and difficult research territory. Nevertheless, in order to maintain scientific rigour, community engagement, and acceptability for the trial, it was necessary we continued to try to deliver this research to support participants diagnosed with depressive disorders, to continue their treatment plans. Restrictions to on-site access, implementation of the protocol while working remotely, and difficulties in communication with participants resulted in multiple challenges.

Impact on community

This project was initially developed after local communities and Indigenous Elders expressed concern about the level of mental illness in their community and a culturally acceptable way of managing it would be beneficial. Any plans to modify the study protocol needed to be discussed with the community to maintain a culturally acceptable connection with community participants who are already enrolled and receiving the IMMHC treatments and/or waiting to commence treatment in the study. In addition to other factors, increased risk, the effects of isolation, social distancing, job loss and economic burden associated with the COVID-19 pandemic makes already vulnerable groups disproportionately more vulnerable.

Given the potential implications of discontinuing the study, the decision to amend the RCT protocol was put forward to community members and feedback was sought. The main community recommendation was to provide ongoing support and continuation of established connections with our participants to ensure they were aware of any changes being made. In addition, it was important that we ensured existing and future participants were healthy and happy to continue in the trial at all times. Open communication regarding potential difficulties participants may be facing to continue their participation in the trial was also a contributing factor to the protocol amendments. Lastly, being mindful of any impacts participants might be experiencing because of the pandemic (ie, job loss, mental health effects, home schooling, government restrictions, and guidelines specific for Indigenous communities) was necessary when implementing any changes to the trial.

Although the continuation of the RCT is a significant challenge in itself, a majority of our participants and community identified that halting the project would cause more harm than good and suggested ways to modify the protocol while still remaining culturally acceptable and adhering to government and research guidelines. As such, the IMMHC protocol has been temporarily amended to include conditional measures to continue this essential project at a time when many from the study population would be experiencing adverse mental health.

The study will now also facilitate the conduct of a remote telehealth model of participant recruitment, screening and participation using available video-consultation technology. Participants with access to video-consultation resources in their homes will be able to participate at home; those without such resources will have the option to use a telehealth service set up in a private room located at the participating Indigenous medical service. All existing participants in the study will be informed of protocol amendments resulting from COVID-19 implications and will be given the option to continue (under the revised protocol) or withdraw from the study. The use of existing technologies such as telehealth may be a vital tool to investigate during a time when it is unknown when this population can attend traditional health services again.

Impact on researchers

For many researchers, the switch to a telehealth mode of research may seem a quick and easy solution. For Indigenous communities, who are heavily reliant on face-to-face engagement, interaction and establishing connections to pursue positive research environments, the continuation of the RCT with participants and engaging with communities using this mode of RCT delivery will no doubt be challenging. In any case, despite the challenges, this project will provide significant outcomes for participants, the collaborating Aboriginal medical services, and other Indigenous communities and medical services.

If successful, the study will have a substantial impact on standard health and telehealth service delivery in the Indigenous health sector and should inform and motivate changes in policy that direct more mental health resources into primary health care services used by Indigenous Australians. Although the amendments to the protocol may not result in the initial outcomes the researchers intended, any outcomes that result from the involvement and empowerment of participants are a beneficial step forward.

Impact on funding

Lastly, impacts on project funding are worth mentioning. Due to the change in research environment during this pandemic, limited access to and use of resources has had a significant impact on the way the trial is conducted. Restrictions on funding expenditure, for example for travel, and other support mechanisms provided to participants in the trial, has had significant hindrances to the conduct of the trial. A revision to the allocated project budget is always a difficult decision; however, given the current situation, it has no doubt been necessary. In this instance, we are mindful and appreciative of the NHMRC’s support and provision of amendments to currently funded projects.


During times of crisis, it is imperative that the potential benefits of critical research is re-evaluated and balanced against potential negative impacts. In such a situation, it is vital that engagement and participatory research approaches are maintained with Indigenous communities. For a trial that aims to provide an Indigenous model of mental health care, the importance of taking care of participant’s mental health is paramount. The effects on communities, researchers and funding described herewith have provided important insights for other projects involving the research of Indigenous mental health. Without a doubt, the impact of the COVID-19 pandemic on Indigenous research has been substantial. Ongoing challenges will continue to be faced and implications will continue to arise into the future. As an Indigenous-led and community-designed trial, the unique insights we have gained because of necessary protocol amendments have proven to be immensely valuable for future design and delivery of clinical trials involving Indigenous communities.

Dr Bushra Farah Nasir is an epidemiologist, and a Research Fellow at the Rural Clinical School, Faculty of Medicine, The University of Queensland.

Professor Sharon Brennan-Olsen is a social epidemiologist, Professor of Social Inclusion, Director of the Centre for Health through Action on Social Exclusion at Deakin University’s School of Health and Social Development and Institute for Health Transformation.

Associate Professor Maree Toombs is a senior Indigenous academic, Associate Dean of Indigenous Engagement in the Faculty of Medicine and the Director of Indigenous Health at the Rural Clinical School Faculty of Medicine, The University of Queensland.



The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.

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