A randomised controlled trial of cognitive behaviour therapy and motivational interviewing for people with type 1 diabetes mellitus and suboptimal glycaemic control

ISRCTN	ISRCTN77044517
DOI	https://doi.org/10.1186/ISRCTN77044517
Secondary identifying numbers	HTA 01/17/05

Submission date: 18/08/2003
Registration date: 18/08/2003
Last edited: 08/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Khalida Ismail
Scientific

Clinical Trials Unit
Dept. of Psychological Medicine
Institute of Psychiatry
1st Floor
103 Denmark Hill
London
SE5 8AZ
United Kingdom

Phone	+44 (0)20 7848 5131
Email	Khalida.Ismail@iop.kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study acronym	ADaPT
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Diabetes
Intervention	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.
Intervention type	Other
Primary outcome measure	Added as of 17/12/2008: 12-month change in haemoglobin A1c levels
Secondary outcome measures	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
Overall study start date	01/02/2003
Completion date	31/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	344
Key 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.
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/02/2003
Date of final enrolment	31/05/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Trials Unit

London
SE5 8AZ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results:	18/11/2008		Yes	No