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CBT in Adolescents With Type 1 Diabetes

This study has been completed.
ClinicalTrials.gov Identifier:
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.
Diabetes UK
Information provided by:
University of Bristol
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.

Condition Intervention
Type 1 Diabetes Mellitus Behavioral: Cognitive Behaviour Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Cognitive Behaviour Therapy: Efficacy and Acceptability for Adolescents With Type 1 Diabetes.

Resource links provided by NLM:

Further study details as provided by University of Bristol:

Primary Outcome Measures:
  • HBA1c

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 90
Study Start Date: September 2001
Estimated Study Completion Date: June 2005
Detailed Description:
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.

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360061

United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University of Bristol
Diabetes UK
Principal Investigator: Elizabeth C Crowne, MD UBHT
Study Chair: Ruth J Allen, PhD University of Bristol
  More Information

ClinicalTrials.gov Identifier: NCT00360061     History of Changes
Other Study ID Numbers: ECCRA/2001
DUK grant BDA: RD01/0002114
First Submitted: August 1, 2006
First Posted: August 3, 2006
Last Update Posted: August 3, 2006
Last Verified: June 2001

Keywords provided by University of Bristol:
Type 1 Diabetes Mellitus
Cognitive Behaviour Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases