CBT in Adolescents With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Diabetes UK
Information provided by:
University of Bristol
ClinicalTrials.gov Identifier:
NCT00360061
First received: August 1, 2006
Last updated: NA
Last verified: June 2001
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360061

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

No publications provided

ClinicalTrials.gov Identifier: NCT00360061     History of Changes
Other Study ID Numbers: ECCRA/2001, DUK grant BDA: RD01/0002114
Study First Received: August 1, 2006
Last Updated: August 1, 2006
Health Authority: United Kingdom: Department of Health

Keywords provided by University of Bristol:
Type 1 Diabetes Mellitus
Adolescents
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

ClinicalTrials.gov processed this record on August 01, 2014