None listed
Conditions
Brief summary
Approval # H11321 Approved by the Human Research Ethics Committee at Western Sydney University Type 2 diabetes (T2D) is an increasing health and economic burden in Australia that is frequently associated with depression and psychological distress. The annual incidence of T2D in Australia could be higher than 10% for adults with depression who have impaired glucose regulation (‘pre-diabetes’). Lifestyle programs aimed at achieving and maintaining a healthy weight are recommended for the primary prevention of T2D, especially for people with pre-diabetes. Lifestyle guidelines, based on findings of several large-scale clinical trials that excluded people with prevalent psychopathology, cannot be generalised to people with depression, who are least likely to engage in or adhere to healthy lifestyle recommendations and may be taking diabetogenic medications (e.g. some anti-depressants). Depression presents a major barrier to effective and sustained healthy lifestyle changes (especially exercise) that needs to be addressed to prevent T2D in this high-risk population group. While both collaborative, multidisciplinary care (‘team-based care’) and lifestyle programs are known to be effective interventions for depression treatment and diabetes prevention, respectively, there is a lack of information on how to effectively prevent T2D in community-based patients with co-morbid depression and pre-diabetes in the Australian primary health care system. Specific aims 1.To provide preliminary evidence on the effectiveness of collaborative, multidisciplinary health services covered by the Medicare Benefits Schedule (MBS) for preventing T2D in community-based patients with co-morbid depression and pre-diabetes (DPD care) compared with usual general practitioner (GP) care 2.To assess the feasibility of conducting a large, full-scale study
Interventions
Collaborative care Collaborative care includes the use of both the Chronic Disease Management items (for pre-diabetes) and the GP Mental Health Treatment items (for depression) to prepare two separate but integrated, concurrent care plans. 1. GP Mental Health Treatment Plan for Depression The MBS (Medicare Benefits Schedule) items provide a structured framework for GPs to undertake early intervention, assessment and management of patients with mental disorders, as well as providing referral pathways to clinical psychologists, registered psychologists, and appropriately trained social workers and occupational therapists. *Psychological Services Eligible participants may be offered referrals for up to 10 individual services per calendar year. These will be used to assess and treat depression, and to identify and modify maladaptive behaviours (healthy behaviour modification counselling). Patients refusing to see the clinical psychologist will be offered counselling by the study GP as per usual care. The GP will complete the Mental Health Care Plan and refer the patient to the psychologist. The psychologist is required to send a report to the GP to document progress after 6 sessions and then the GP will write another referral for a further 4 sessions if deemed necessary. 2. Chronic Disease Management items for Pre-diabetes There are four relevant Chronic Disease Management items that provide rebates for study GPs to manage the ‘pre-diabetes’ by preparing, coordinating, reviewing or contributing to Chronic Disease Management plans. *Allied Health Services (Exercise Physiologists) A Medicare rebate is available for a maximum of 5 individual services per calendar year. Accredited exercise physiologists have the ability to combine general nutritional principles with exercise advice to increase the effectiveness of their health and wellbeing interventions, especially for weight loss. Participants will be encouraged to achieve a 5% reduction in weight per calendar year, and be advised to monitor and record their own weight weekly to promote weight-loss by the study GP. The GP will communicate this goal to the exercise physiologist, who is required to send a report to the GP to document progress after 5 sessions. Participants who smoke will be encouraged to discuss smoking cessation program options with the GP, given the excess risk of diabetes associated with active smoking.
Sponsors
Study design
Eligibility
Inclusion criteria
We will include participants meeting all of the following criteria: 1. Give freely written informed consent 2. Aged 40 to 74 years; the arbitrary lower age limit was chosen because of the sharp rise in the prevalence and incidence of diabetes in middle-aged Australians. The arbitrary upper age limit of 74 years was chosen because of the sharp rise in deaths in Australians aged 75 years or older 3. At least overweight defined by body mass index greater than or equal to 25 kg/m2 computed from measured height and weight 4. Confirmed pre-diabetes defined by impaired fasting glucose (IFG) (FPG levels plasma glucose levels 5.6–6.9mmol/L), or impaired glucose tolerance (IGT) (2-h PG Oral Glucose Tolerance Test [OGTT] levels of 7.8–11.0mmol/L), or HbA1c levels 5.7–6.4% according to the American Diabetes Association (ADA) criteria; pre-diabetes patients treated with Metformin are eligible 5. Clinically significant depression (using scores greater than or equal to 10 for moderate to severe symptoms) with the Patient Health Questionnaire-9 (PHQ-9) 6. Be at either (1) pre-contemplation, (2) contemplation, or (3) preparation stage of readiness to lose weight using the following question and response options based on the Prochaska Stage of Behavior Change model
Exclusion criteria
1. Diabetes (type 1 or monogenic or type 2 or gestational diabetes) determined by self-report (doctor diagnosis or prescriptions for anti-diabetes medications) 2. Current or previous psychotic symptoms by standard medical history/self-report 3. Currently receiving treatment for breast, liver cancer or other malignancy, which could affect compliance with the protocol or interpretation of study results. Non-melanoma skin cancer(s) treated with curative intent are eligible 4. Unable to communicate effectively in English judged by the Investigator during face-to-face or telephone contact to screen for study eligibility 5. Current or planned pregnancy