CBT in Adolescents With Type 1 Diabetes

• Sponsor: University of Bristol (Other)
• Overall Status: Completed
• CT.gov ID: NCT00360061
• Collaborator: Diabetes UK (Other)
• Enrollment: 90
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Behavioral: Cognitive Behaviour Therapy	N/A

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.

Study Design

• Study Type: Interventional
• 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.
• Study Start Date: Sep 1, 2001
• Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. HBA1c []

Secondary Outcome Measures

1. Well Being Questionnaire, Children's Health locus of control, []

2. Diabetes Quality of Life for Youths (modified from DCCT), []

3. Self Efficacy for Diabetes Scale (modified version,), []

4. Diabetes Family Behaviour Scale, Diabetes Readiness to Change Questionnaire, []

5. Modified Health Care Climate Questionnaire (at baseline only). []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 16 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00360061
• Other Study ID Numbers: ECCRA/2001; DUK grant BDA: RD01/0002114
• First Posted: Aug 3, 2006
• Last Update Posted: Aug 3, 2006
• Last Verified: Jun 1, 2001

• Keywords provided by , ,: Type 1 Diabetes Mellitus; Adolescents; Cognitive Behaviour Therapy
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Aug 3, 2006