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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
ISRCTN ISRCTN77044517
ClinicalTrials.gov identifier
Public title A randomised controlled trial of cognitive behaviour therapy and motivational interviewing for people with type 1 diabetes mellitus and suboptimal glycaemic control
Scientific title
Acronym ADaPT
Serial number at source HTA 01/17/05
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

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.

Please note that the target number of participants was added as of 17/12/2008.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Diabetes
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.
Participants - exclusion criteria Does not meet the inclusion criteria
Anticipated start date 01/02/2003
Anticipated end date 31/05/2007
Status of trial Completed
Patient information material
Target number of participants 344
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.
Primary outcome measure(s) Added as of 17/12/2008:
12-month change in haemoglobin A1c levels
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
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2008 results: http://www.ncbi.nlm.nih.gov/pubmed/19017589
Contact name Dr  Khalida  Ismail
  Address Clinical Trials Unit
Dept. of Psychological Medicine
Institute of Psychiatry
1st Floor
103 Denmark Hill
  City/town London
  Zip/Postcode SE5 8AZ
  Country United Kingdom
  Tel +44 (0)20 7848 5131
  Fax +44 (0)20 7848 5468
  Email Khalida.Ismail@iop.kcl.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website http://www.dh.gov.uk/en/index.htm
Date applied 18/08/2003
Last edited 08/09/2009
Date ISRCTN assigned 18/08/2003