CBT in Adolescents With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Randomised Controlled Trial of Cognitive Behaviour Therapy: Efficacy and Acceptability for Adolescents With Type 1 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360061
• Other study ID #: ECCRA/2001
• Secondary ID: DUK grant BDA: R
• Status: Completed
• Phase: N/A
• First received: August 1, 2006
• Last updated: August 1, 2006
• Start date: September 2001
• Est. completion date: June 2005

Study information

• Verified date: June 2001
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Cognitive Behaviour Therapy

Locations

Country	Name	City	State
United Kingdom	Bristol Royal Hospital for Children	Bristol

Sponsors (2)

Lead Sponsor	Collaborator
University of Bristol	Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBA1c
Secondary	Well Being Questionnaire, Children’s Health locus of control,
Secondary	Diabetes Quality of Life for Youths (modified from DCCT),
Secondary	Self Efficacy for Diabetes Scale (modified version,),
Secondary	Diabetes Family Behaviour Scale, Diabetes Readiness to Change Questionnaire,
Secondary	Modified Health Care Climate Questionnaire (at baseline only).