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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000587303

Acronym

MADE-IT study

Enrollment

300

Registered

2008-11-21

Start date

2007-04-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diabetes type II and Beck Depression Inventory score of >15.

Exclusion criteria

people with moderate or severe cognitive impairment people who are not competent in English people with a psychotic illness People with diabetes type I

Outcome results