CBT in Adolescents With Type 1 Diabetes
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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. |
- HBA1c
- 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 |
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 |
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| United Kingdom | |
| Bristol Royal Hospital for Children | |
| Bristol, United Kingdom, BS2 8BJ | |
| 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 May 16, 2013