Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000255381
Ethics application status
Approved
Date submitted
9/04/2008
Date registered
20/05/2008
Date last updated
17/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Problem solving in people with diabetes and depressive symptoms
Scientific title
In people with diabetes and depressive symptoms is problem solving therapy plus self help and a letter to the GP better than self help and a letter to the GP alone in reducing depressive symptoms and improving diabetes management after 6 months.
Secondary ID [1] 252039 0
Nil
Universal Trial Number (UTN)
Trial acronym
PSAD (Problem solving and diabetes)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 3022 0
Condition category
Condition code
Metabolic and Endocrine 3171 3171 0 0
Diabetes
Mental Health 3172 3172 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Problem solving therapy - 6 to 8 sessions of problem solving therapy plus self help materials and a letter to the GP. Problem solving therapy will be 60 minute sessions once a week for 6 to 8 weeks. (See www.problemsolvingtherapy.ac.nz for more details of the problem solving therapy).
Intervention code [1] 2763 0
Treatment: Other
Comparator / control treatment
Self help information and a letter to the GP. Self help information is leaflets and web site about depression and diabetes. Letter to the GP notes that they have screened positive for depression with some brief advice about current treatments for depression in diabetes.
Control group
Active

Outcomes
Primary outcome [1] 4056 0
Depressive symptoms - score on the Hospital and Anxiety Depression Scale below 11
Timepoint [1] 4056 0
3 and 6 months
Secondary outcome [1] 6829 0
HbA1C (routine blood test)
Timepoint [1] 6829 0
3 and 6 months

Eligibility
Key inclusion criteria
1. Consecutive patients attending the diabetic clinics at Waitemata DHB, Auckland will be screened with the Hospital Anxiety and Depression Scale [12]. This is a self rating scale that is designed to assess the severity of anxiety or depressive symptoms in medical out patients. Patients scoring 11 or over on the depressive sub scale or with a total score over 20 will be invited to take part in the study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitive impairment
2. Currently psychotic

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment outside Australia
Country [1] 884 0
New Zealand
State/province [1] 884 0

Funding & Sponsors
Funding source category [1] 3278 0
University
Name [1] 3278 0
University of Auckland
Country [1] 3278 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1
Country
New Zealand
Secondary sponsor category [1] 2930 0
None
Name [1] 2930 0
Address [1] 2930 0
Country [1] 2930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5265 0
Ethics committee address [1] 5265 0
Ethics committee country [1] 5265 0
Date submitted for ethics approval [1] 5265 0
11/04/2008
Approval date [1] 5265 0
Ethics approval number [1] 5265 0

Summary
Brief summary
The primary purpose of the study is to see if a brief psychological intervention plus self help and a letter to the GP is better than self help and a GP letter alone in the management of people with diabetes and depressive symptoms. The self help material consists of leaflets and a web site. The letter to the GP tells the GP that the person with diabetes has depressive symptoms and provides some information about treatment options. Participants will be followed up for six months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28509 0
Address 28509 0
Country 28509 0
Phone 28509 0
Fax 28509 0
Email 28509 0
Contact person for public queries
Name 11666 0
Dr. Simon Hatcher
Address 11666 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1
Country 11666 0
New Zealand
Phone 11666 0
+64 9 373 7599 x86750
Fax 11666 0
Email 11666 0
s.hatcher@auckland.ac.nz
Contact person for scientific queries
Name 2594 0
Dr. Simon Hatcher
Address 2594 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1
Country 2594 0
New Zealand
Phone 2594 0
+64 9 373 7599 x86750
Fax 2594 0
Email 2594 0
s.hatcher@auckland.ac.nz

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.