RecruitingACTRN12608000587303

Innovative ways of treating comorbid diabetes type II and depression: the "MADE-IT" Program

Assessing the effectiveness in reducing depressive symptomatology of single focussed Cognitive Behaviour therapy (CBT), minimal intervention and integrated CBT and diabetes education treatment for people with comorbid diabetes type II and depression.

Sponsor

Centre for Rural & Remote Mental Health (University of Newcastle)

Enrollment

300 participants

Start Date

Apr 30, 2007

Study Type

Interventional

Conditions

Diabetes type II and Depression

Summary

Research has shown that people with Type II Diabetes are at increased risk of developing depression, and the combination of both disorders increases the likelihood of the development of diabetes related complications. Diabetes related complications often means increased need for medical interventions, increased hospitalizations and generally poorer health outcomes for patients. This research projects aims to evaluate interventions for depression in patients with Diabetes type II. Minimal intervention (self help resources and regular monitoring) single focused intervention (depression alone treatment) and integrated treatment (depression intervention and diabetes education) will be compared. Participants in the depression focussed or integrated treatments will attend small group sessions for 90 minutes each week over eight weeks. Outcomes (depressive symptoms, self care beahviours and HbA1c) will be measured post treatment, three and six months.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who have both type 2 diabetes and depression, as these two conditions often occur together and each makes the other worse. Researchers are comparing three approaches: minimal support (self-help resources and check-ins), treatment focused only on depression, and an integrated approach that treats both depression and diabetes education together. Group sessions run for 90 minutes each week over 8 weeks. Researchers will measure depression symptoms, diabetes self-care, and blood sugar levels over 6 months. You may be eligible if: - You have been diagnosed with type 2 diabetes - You have a Beck Depression Inventory score above 15, suggesting moderate to severe depression - You are 18 years of age or older You may NOT be eligible if: - You have moderate or severe problems with memory or thinking (cognitive impairment) - You are not able to communicate in English - You have a psychotic illness (such as schizophrenia) - You have type 1 diabetes Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants with diabetes type II and depression will be randomly allocated to Intervention Group 1(depression focussed CBT) or Intervention Group 2 (integrated CBT & diabetes education) Depression

Participants with diabetes type II and depression will be randomly allocated to Intervention Group 1(depression focussed CBT) or Intervention Group 2 (integrated CBT & diabetes education) Depression focussed treatment covers relationship between thoughts and feelings, thought challenging, behavioural activation, problem solving, mindfulness, schema therapy and relapse prevention. Integrated treatments cover relationship between thoughts and feelings, thought challenging, behavioural activation, problem solving, mindfulness, schema therapy and relapse prevention, understanding diabetes and the diabetes pathway, medications, foot care, dietary information (Glycaemic Index, fats, sodium & sugar), label reading, health plans. Both interventions are delivered in small groups, for 90 minutes sessions once a week, over eight weeks.

Locations(1)

Australia

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ACTRN12608000587303