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Trial registered on ANZCTR


Registration number
ACTRN12608000587303
Ethics application status
Approved
Date submitted
2/04/2007
Date registered
21/11/2008
Date last updated
21/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Innovative ways of treating comorbid diabetes type II and depression: the "MADE-IT" Program
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
MADE-IT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes type II and Depression 2142 0
Condition category
Condition code
Metabolic and Endocrine 2238 2238 0 0
Diabetes
Mental Health 2239 2239 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3709 0
Treatment: Other
Comparator / control treatment
Minimal intervention involves fortnightly collection of measures (Beck Depression Inventory-fast screen (BDI-FS) and Problem Areas in Diabetes Scale (PAID), and Fasting glucose for that day . Phone calls are brief, around ten minutes in duration.
The participants for minimal intervention are provided with basic depression information handouts and a self help book on depression after BDI at week 4, when their scores fall below fifteen, and exclude them from randomisation to intervention groups. Self help information and resources are mailed out.
Control group
Active

Outcomes
Primary outcome [1] 3098 0
Reduced depressive symptomatology on Beck Depression Scale and by Clinical Assessment (using SCID - Depression rating)
Timepoint [1] 3098 0
Depression ratings are conducted at Baseline, Post treatment, 3 months and 6 months post treatment.
Secondary outcome [1] 5195 0
Improved self care behaviours (Blood Glucose Level (BGL) monitoring, medication adherence, exercise, diet ahderence) and improved glycosated Hameoglobin levels(HbA1c).
Timepoint [1] 5195 0
ratings are conducted at Baseline, Post treatment, 3 months and 6 months post treatment
Secondary outcome [2] 5196 0
Self report by participants' on BGL's, medication adherence (or changes), levels of exercise, and dietary adherence are recorded fortnightly by researcher
Timepoint [2] 5196 0
ratings are conducted at Baseline, Post treatment, 3 months and 6 months post treatment

Eligibility
Key inclusion criteria
Diabetes type II and Beck Depression Inventory score of >15.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants undergo comprehensive assessment and then are tracked for fasting BGL, scores on BDI-FS and PAID Scale measures each two weeks for four weeks.
At four weeks participants with BDI-FS< 15 will be allocated to the minimal intervention, and those with BDI-FS >15 will be randomly allocated to either depression alone or integrated treatment conditions. A computer generated sequence has been given to a central register person(blinded). Allocation for participants is made by phone call to this register.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence by computer generated randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1302 0
2800
Recruitment postcode(s) [2] 1303 0
2795

Funding & Sponsors
Funding source category [1] 2397 0
Commercial sector/Industry
Name [1] 2397 0
Novo Nordisk competitive grants
Country [1] 2397 0
Australia
Funding source category [2] 4177 0
Other Collaborative groups
Name [2] 4177 0
NSW Institute of Psychiatry - Research Fellowship 2007
Country [2] 4177 0
Australia
Primary sponsor type
University
Name
Centre for Rural & Remote Mental Health (University of Newcastle)
Address
Bloomfield Campus
Forest Road
Orange NSW
Country
Australia
Secondary sponsor category [1] 3749 0
Other
Name [1] 3749 0
NSW Institute of Psychiatry
Address [1] 3749 0
C/-Cumberland Hosptial
Phillip Street
North Parramatta NSW
Country [1] 3749 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4228 0
Greater Western Area Health Service (sites at Orange and Bathurst)
Ethics committee address [1] 4228 0
Ethics committee country [1] 4228 0
Australia
Date submitted for ethics approval [1] 4228 0
Approval date [1] 4228 0
10/04/2007
Ethics approval number [1] 4228 0
GW2007/09
Ethics committee name [2] 4229 0
North Sydney/Central Coast Area Health Service HREC
Ethics committee address [2] 4229 0
Ethics committee country [2] 4229 0
Australia
Date submitted for ethics approval [2] 4229 0
Approval date [2] 4229 0
01/07/2007
Ethics approval number [2] 4229 0
0707-069M
Ethics committee name [3] 6231 0
University of Newcastle HREC
Ethics committee address [3] 6231 0
Ethics committee country [3] 6231 0
Australia
Date submitted for ethics approval [3] 6231 0
Approval date [3] 6231 0
10/04/2007
Ethics approval number [3] 6231 0
H-428-3007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27790 0
Address 27790 0
Country 27790 0
Phone 27790 0
Fax 27790 0
Email 27790 0
Contact person for public queries
Name 10876 0
Leigh Underwood
Address 10876 0
C/- Centre for Rural & Remote Mental Health
Bloomfield Campus
Forest Road
Orange NSW 2800
Country 10876 0
Australia
Phone 10876 0
+ 61 2 63 607828
Fax 10876 0
+61 2 63 61 2457
Email 10876 0
Leigh.Underwood@gwahs.health.nsw.gov.au
Contact person for scientific queries
Name 1804 0
Prof Brian Kelly
Address 1804 0
C/- Centre for Rural & Remote Mental Health
Bloomfield Campus
Forest Road
Orange NSW 2800
Country 1804 0
Australia
Phone 1804 0
+ 61 2 63 607828
Fax 1804 0
+61 2 63 61 2457
Email 1804 0
Brian.Kelly@gwahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.