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CBT in Adolescents With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00360061
First Posted: August 3, 2006
Last Update Posted: August 3, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Diabetes UK
Information provided by:
University of Bristol
August 1, 2006
August 3, 2006
August 3, 2006
September 2001
Not Provided
HBA1c
Same as current
No Changes Posted
  • Well Being Questionnaire, Children’s Health locus of control,
  • Diabetes Quality of Life for Youths (modified from DCCT),
  • Self Efficacy for Diabetes Scale (modified version,),
  • Diabetes Family Behaviour Scale, Diabetes Readiness to Change Questionnaire,
  • Modified Health Care Climate Questionnaire (at baseline only).
Same as current
Not Provided
Not Provided
 
CBT in Adolescents With Type 1 Diabetes
Randomised Controlled Trial of Cognitive Behaviour Therapy: Efficacy and Acceptability for Adolescents With Type 1 Diabetes.
The effectiveness of cognitive behavioural therapy (CBT) for adolescents with type 1 diabetes will be tested. This structured, time-limited, problem-orientated therapy will be used to impact on psychosocial factors influencing diabetic control, with the patient and therapist working together on specific goals to develop adaptive strategies.
Ninety 11-16 year olds with T1DM (duration >1 year), attending paediatric diabetes outpatient clinics based in 4 centres in South-West England, UK, will be recruited to a randomised controlled trial of one to one sessions of CBT versus non-directive supportive counselling. Participants will attend up to 6 sessions (weekly) with either a CBT therapist or a counsellor, with 2 further sessions at 6 and 12 months. Follow up will continue for 12 months post intervention. HbA1c is the primary outcome measure. Psychological measures will also be measured.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Behavioral: Cognitive Behaviour Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2005
Not Provided

Inclusion Criteria:

  • Attendance at out-patients clinics at Bristol Royal Hospital for Children, Southmead Hospital in Bristol, Weston General Hospital, The Royal United Hospital in Bath, Gloucestershire Royal Hospital in Gloucester or the Musgrove Park branch of the Taunton and Somerset Hospital Aged 11-16 years old (inclusive) on the first day of the study Type 1 diabetes Duration at least 12 months on the first day of the study

Exclusion Criteria:

  • chronic illnesses with dietary management implications (e.g. cystic fibrosis and coeliac disease) special educational needs (e.g. Down's syndrome) making the patient unable to co-operate with CBT in care of social services primary responsibility for care elsewhere English not spoken as a first language Known psychological/ psychiatric problems for which the patient has already been referred
Sexes Eligible for Study: All
11 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00360061
ECCRA/2001
DUK grant BDA: RD01/0002114
Not Provided
Not Provided
Not Provided
Not Provided
University of Bristol
Diabetes UK
Principal Investigator: Elizabeth C Crowne, MD UBHT
Study Chair: Ruth J Allen, PhD University of Bristol
University of Bristol
June 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP