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A randomised controlled trial of cognitive behaviour therapy and motivational interviewing for people with type 1 diabetes mellitus and suboptimal glycaemic control
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| ISRCTN |
ISRCTN77044517
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| ClinicalTrials.gov identifier |
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| Public title |
A randomised controlled trial of cognitive behaviour therapy and motivational interviewing for people with type 1 diabetes mellitus and suboptimal glycaemic control
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| Scientific title |
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| Acronym |
ADaPT
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| Serial number at source |
HTA 01/17/05
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| Study hypothesis |
1. To test whether brief computer assisted motivational interviewing (MI) is more effective than usual medical care in improving glycaemic control in a population based sample of younger adults with type 1 diabetes
2. To test whether cognitive behaviour therapy (CBT) is more effective than usual medical care in improving glycaemic control in a population based sample of younger adults with type 1 diabetes and persistent suboptimal glycaemic control after brief MI
3. To examine cognitive, behavioural and biological predictors of outcome after MI and after CBT
4. To examine the cost effectiveness and cost utility of each intervention
5. To examine factors which may modify or mediate the process of change
6. To assess whether training and supervision can lead to a change in the consultation behaviour of nurses
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Ethics approval
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Not provided at time of registration
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| Study design |
Randomised controlled trial
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| Countries of recruitment |
United Kingdom
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| Disease/condition/study domain |
Diabetes
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| Participants - inclusion criteria |
Patients who have had glycated haemoglobin values of 8.2% and greater in the past 12 months and currently, will be defined as having persistent sub-optimal glycaemic control and are eligible for the study.
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| Participants - exclusion criteria |
Does not meet the inclusion criteria
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| Anticipated start date |
01/02/2003
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| Anticipated end date |
31/05/2007
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| Status of trial |
Completed
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| Patient information material |
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| Target number of participants |
344 (added as of 17/12/2008)
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| Interventions |
Please note that, as of 17 January 2008, the start and end date of this trial were updated from 1 January 2002 and 31 December 2004 to 1 February 2003 and 31 May 2007, respectively.
Interventions:
1. Brief therapy: motivational interviewing (MI)
2. Intensive therapy: motivational interviewing followed by cognitive behaviour therapy (CBT)
3. No therapy
All patients will continue to receive their usual diabetes care.
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| Primary outcome measure(s) |
Added as of 17/12/2008:
12-month change in haemoglobin A1c levels
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| Secondary outcome measure(s) |
Added as of 17/12/2008:
1. Hypoglycaemic events
2. Depression
3. Quality of life
4. Fear of hypoglycaemia
5. Diabetes self-care activities
6. Body mass index
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| Sources of funding |
NIHR Health Technology Assessment Programme - HTA (UK)
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| Trial website |
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| Publications |
2008 results: http://www.ncbi.nlm.nih.gov/pubmed/19017589
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| Contact name |
Dr
Khalida
Ismail
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| Address |
Clinical Trials Unit
Dept. of Psychological Medicine
Institute of Psychiatry
1st Floor
103 Denmark Hill
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| City/town |
London
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| Zip/Postcode |
SE5 8AZ
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| Country |
United Kingdom
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| Tel |
+44 (0)20 7848 5131
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| Fax |
+44 (0)20 7848 5468
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| Email |
Khalida.Ismail@iop.kcl.ac.uk
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| Sponsor |
Department of Health (UK)
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| Address |
Quarry House
Quarry Hill
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| City/town |
Leeds
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| Zip/Postcode |
LS2 7UE
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| Country |
United Kingdom
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| Email |
Sheila.Greener@doh.gsi.gov.uk
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| Sponsor website |
http://www.dh.gov.uk/en/index.htm
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| Date applied |
18/08/2003
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| Last edited |
17/12/2008
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| Date ISRCTN assigned |
18/08/2003
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