Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/08/2003
Date assigned
18/08/2003
Last edited
08/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Khalida Ismail

ORCID ID

Contact details

Clinical Trials Unit
Dept. of Psychological Medicine
Institute of Psychiatry
1st Floor
103 Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 7848 5131
Khalida.Ismail@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/17/05

Study information

Scientific title

Acronym

ADaPT

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2003

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

344

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/02/2003

Recruitment end date

31/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results: http://www.ncbi.nlm.nih.gov/pubmed/19017589

Publication citations

  1. Results

    Ismail K, Thomas SM, Maissi E, Chalder T, Schmidt U, Bartlett J, Patel A, Dickens CM, Creed F, Treasure J, Motivational enhancement therapy with and without cognitive behavior therapy to treat type 1 diabetes: a randomized trial., Ann. Intern. Med., 2008, 149, 10, 708-719.

Additional files

Editorial Notes