None listed
Conditions
Brief summary
The current study aims to address a major gap in care for people with diabetes distress (DD). By conducting a pragmatic randomised controlled trial, the goal is to compare three models of care for people with DD: i) SMOC (recommend GP to refer patient to a psychologist via the mental health care plan) ii) IMOC (individual assessment and management of DD by a DM-informed psychologist) and iii) GMOC (6-session behavioural therapy program delivered via Virtual Care group by DM-informed psychologist and diabetes educator; 3-6 participants per group). Specifically, the study aims to determine the comparative efficacy of GMOC, IMOC and SMOC in improving DD, glycaemic control and reducing hospitalisations in patients with T1DM and DD. The cost effectiveness of each Model of Care will also be examined. The research will generate new knowledge and evidence regarding sustainable models of care addressing an urgent clinical need, as diabetes places an increasing burden on our health system.
Interventions
Participants will be randomly allocated to three different models of care for management of diabetes distress:
1. Individual model of care (IMOC): assessment and management of diabetes distress
IMOC delivered by a clinical psychologist is supported by international clinical trial evidence, recommended in guidelines, and is standard care at the 4 hospitals with a DM Service clinical psychologist (Speight, 2026). Patients referred to IMOC will be contacted to organise an initial assessment with t
Participants will be randomly allocated to three different models of care for management of diabetes distress: 1. Individual model of care (IMOC): assessment and management of diabetes distress IMOC delivered by a clinical psychologist is supported by international clinical trial evidence, recommended in guidelines, and is standard care at the 4 hospitals with a DM Service clinical psychologist (Speight, 2026). Patients referred to IMOC will be contacted to organise an initial assessment with the clinical psychologist at each of the 3 sites currently using IMOC. Appointments will be organized in the usual clinical care manner at each site. The clinical psychologist making the initial assessment and management will organise follow-up appointments at a frequency and number determined by their clinical judgement for each individual patient participant (usually 3-4 sessions, but individualised). Appointments are usually up to 60 mins in duration and the treatment methods are individually tailored for each participant. Sessions with the psychologist are focused solely managing diabetes distress; treatment is integrated with DM multi-disciplinary care. It can be delivered either face to face (F2F) or virtually. There are no physical or informational materials provided to all participants assigned to this group. However, some psychologists may provided individual patients with individually tailored informational resources. 2. Group model of care (GMOC): online group assessment and management of diabetes distress GMOC is a virtual behavioural intervention, based on functional-analytic and behavioural self-management models, delivered in small groups of 3-6 patients. The program is facilitated by a psychologist, who is assisted by a diabetes educator. The program comprises a 6-session multi-component intervention, involving two-hour long group sessions that are held weekly for first 5 weeks followed by a 1-month follow-up, after a 4 week planned ‘self-management’ for maintenance phase. In the program, each patient is provided with a workbook which they will work through individually each session, with the assistance of facilitators. 3. Standard model of care (SMOC): recommendation to participant and their GP to refer participant to a clinical psychologist under a mental health care plan. This is currently standard clinical care in most parts of Australia. The duration of the allocated intervention will depend on which model of care a participant is randomised to. For the IMOC and SMOC, the duration will be individualised and determined by the treating clinical psychologist. For the GMOC, the intervention will de delivered over 9 weeks. In the IMOC and GMOC, facilitators will complete a questionnaire for each participant, each session, to assess and monitor program activities and participants' attendance, engagement and progress, where relevant.
Sponsors
University of Sydney - Faculty of Medicine and Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has type 1 diabetes 2. Age: 16 years or older 3. Has moderate to high diabetes distress, defined by score on Type 1 – DDAS questionnaire of 2.5 or higher. 4. Has - poor glycaemic control with HbA1c = 8% or -recent diabetes related hospital admission and/or -conflict with the treating MDT or family over DM management. 5. Willingness to provide informed consent and willingness to participate and comply with the study requirements. 6. Received their type 1 diabetes diagnosis at least 12 months prior.
Exclusion criteria
1. Has a diabetes type other than type 1 diabetes 2. Age <16 years, 3. Has type 1 diabetes diagnosed less than 1 year ago (rationale for this is that people are quite likely to experience diabetes distress at this time due to recency of diagnosis. This may resolve with increased education and competence at self-management) 4. Is pregnant (rationale: additional stressors in pregnancy, glucose targets lower in pregnancy and often women start on insulin pumps/intensive management, which rapidly improves HbA1c) 5. Does not have the cognitive ability to consent to participation 6. Does not have an adequate level of English language skills to be able to participate in the study without use of an interpreter. This will be especially important for participants assigned to the GMOC, which will be conducted only in English. 7. Imminent/high suicide risk (as judged by clinician seeing them, as they need immediate referral to the local acute mental health care team for assessment and management as a priority) 8. Acute psychosis or severe mood disturbance - patients in 6 and 7 will be referred to the acute mental health care team, as per usual practice, 9. Residing in residential care or prison facility (the rationale for this is that they are likely to have more constraints on their ability to attend the intervention appointments, as this is often either beyond their control or less under their control than for people living independently.). 10. Diagnosis of dementia, organic brain syndrome or severe intellectual disability, 11. Alcohol or substance misuse meeting criteria for a disorder within the last 3 months
Outcome results
None listed