None listed
Conditions
Brief summary
Diabetes mellitus is a National Health Priority Area in Australia because of its impact on the Australian community. The MILES Study of Australian community found that 28% of people with T1DM had severe diabetes-related distress, slightly less for T2DM participants (17.22%). For participants with insulin treated T2DM, 35% reported moderate to severe depressive symptoms compared to 22% in T1DM and 23% of noninsulin treatment T2DM participants. Preliminary findings from our pilot studies at St. Vincent’s support this data highlighting the presence of mental health concerns in this population. Government reports have also highlighted the nationwide burden with The Australian Institute of Health and Welfare Report (2011) found 31.0-41.6% of people with diabetes had either medium, high, or very high levels of psychological distress. Underrecognition and undertreatment of mental health disorders, in particular depression, is common in this field however and there is need for further mental health data specific to diabetes. Individuals and their families can experience difficulties and adjustments following a diagnosis of diabetes. Not only is there shock and adjustment to the diagnosis itself, but also challenges adapting to daily self-management regimens. A person’s sense of identity can be affected as they process what it means to be ‘diabetic’ and any associated social, legal and medical implications. A focus on diabetes is especially needed given increased rates of depression and anxiety as well as a near two fold increase of eating disorders in adolescent females with T1DM compared to the general population. There is strong overlap between mental health and diabetes, yet gaps remain in service provision. A recent report by Marrero et al. highlighted the importance of behavioural medicine in diabetes given the significant impact of behaviour on the disease process and management of diabetes. The authors emphasise that developing behavioural change interventions will be as important as medical advances, as people are living longer and will need to adopt regimens for chronic conditions with ways to manage new information and sophisticated treatments. There is some evidence that psychological/behavioural treatments can assist, and these have been shown to improve metabolic control, selfmanagement, quality of life, and blood glucose awareness. Mental Health in Diabetes Optimal Health Program (MINDS OHP) The MINDS OHP is a multidisciplinary collaborative therapy and self-efficacy intervention supporting people with mental or physical illness. The program promotes hope, growth and partnership by providing a comprehensive therapeutic approach for consumers, clinicians, services and other to work systematically towards the achievement of optimal health outcomes. The concept of self-efficacy and care coordination are integral components of OHP. The OHP model is focused on wellbeing with a capacity to include additional components addressing particular mental or physical health problems. OHP is delivered in nine sequential sessions comprising: i) interagency collaboration; ii) care coordination ; and iii) support information and identifying community supports. The MINDS OHP incorporates diabetes-specific information to support the self-efficacy and wellbeing of people living with diabetes. This purpose of this research study is to compare the benefits of an 8week (plus booster session) MINDS OHP targeting wellbeing versus the current standard treatment that is provided. This program aims to teach coping and planning skills that may reduce anxiety and depression in people with diabetes. This study is part of a wider program of research designed to inform the OHP adaptation to chronic illness settings including carers of people with stroke and dialysis. The self-management foundations of OHP are particularly relevant for adults with diabetes, who are faced daily with managing aspects of diabetes including insulin delivery (for some), carbohydrate counting, monitoring blood sugar levels, and of course coping with the emotional impact of this. The collaborative focus of OHP also provides a growth facilitative environment for patients to develop confidence, learn strategies for self-care, and know where to seek further assistance if required. References available upon request
Interventions
The self-management (Optimal Health) program will utilise the Collaborative Therapy Framework delivered by an OHP facilitator. This program is composed of three core components adapted to suit the specific needs of the adult with type I or type II diabetes. This is part of a larger program of larger research study known as the Translational Research, Integrated Public Health Outcomes and Delivery (TRIPOD). TRIPOD is a collaborative effort between three research projects aimed at understanding th
The self-management (Optimal Health) program will utilise the Collaborative Therapy Framework delivered by an OHP facilitator. This program is composed of three core components adapted to suit the specific needs of the adult with type I or type II diabetes. This is part of a larger program of larger research study known as the Translational Research, Integrated Public Health Outcomes and Delivery (TRIPOD). TRIPOD is a collaborative effort between three research projects aimed at understanding the efficacy and impact OHP has on the wellbeing of people with specific chronic health problems and their carers. The study of OHP in carers of stroke survivors has been previously registered as a trial (ACTRN12613000064707.) a) The OHP framework utilises a modular format. Each module encompasses a manualised discrete skill development intervention run over 8 weeks (plus booster session) involving: health promotion, interagency collaboration, accessible support care coordinator, information about diabetes and resources, understanding stress, family and community support and living with diabetes including adjustment to diagnosis and self-management of blood sugar and lifestyle targets. The modular format allows for tailoring of the intervention to suit the needs of adults with type I or type II diabetes at various stages of the illness. Similarity across modules in terms of the core intervention, plus overlap between modules, enhances implementation through familiarity with the methods and style. This also addresses efficiency and cost-effectiveness with respect to training staff. Each session is designed to build on the learnings from the previous session with the ‘I Can Do model’ as the core theme. It is one of the unique components of the Optimal Health Program. b) Self-efficacy is a pivotal part of the process and is taught using a systematic approach to both clinicians and consumers with each module, regardless of content, delivers education, coping strategies, skills development and adaptation paradigms. This supports the philosophy that a person’s illness should not be ‘dependent on’ but ‘supported by’ the services they need to utilise. c) Smooth integration through acute and community services is paramount. Therapeutic and systemic collaboration with consumers and clinicians will be an integral part of the process. Based on the pilot study data, literature, and anecdotal experience the OHP used in the RCT phase 'Mental Health in Diabetes Optimal Health Program' (MINDS OHP) will be specifically tailored to people with diabetes. The MINDS OHP facilitator will draw on diabetes-specific information in concordance with the multidisciplinary team, for example information on the relationship between stress and hypoglycaemia, availability of diabetes supports in the community, and coping strategies for addressing anxiety related to self-management. MINDS OHP sessions will be conducted 1 hour per week for 8 weeks. There may be some unavoidable variation depending on participant circumstances (e.g. ill health may lead to longer break between sessions). Sessions will be conducted one-to-one and sessions are facilitated by a trained OHP facilitator. A single booster session will be conducted with participants 3 months post completion of intervention. The booster session is also one hour duration and the overall theme for this session is to address 'what is my health like now' for participants. This booster session will involve review of health plans 1, 2, and 3, consolidation of progress and reflection on achievements towards health-related goals. Two post-intervention focus groups for patients and clinician participants (nurses, physicians, allied health workers) will also be run to assist in the evaluation of MINDS OHP. Focus groups will be 1 hour duration and dual moderated by a senior member of the investigator team and a student researcher. Post intervention focus groups with clinicians and participants in the RCT will be conducted 3 months after the intervention phase of the trial. Focus groups with OHP participants will be conducted by members of the research team who are not OHP facilitators. OHP facilitators will receive training, and regular weekly supervision to discuss problems and minimise non-standardised activity. In addition, thematic issues will be raised at supervision meetings. OHP faciliators will also maintain session notes and attendance records for each participant to assist with supervision and monitoring of adherence to OHP protocol.
Sponsors
St. Vincent's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years and older with a diagnosis of type I diabetes or type II diabetes and able to converse in English without an interpreter.
Exclusion criteria
Participants who are 1) non-English speaking and 2) unable to consent.
Outcome results
None listed