CBT in Adolescents With Type 1 Diabetes

NCT00360061 | Completed

• 2 other identifiers: ECCRA/2001DUK grant BDA: RD01/0002114
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus; Adolescents; Cognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (1)

• HBA1c

Secondary Outcomes (5)

• 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).

Interventions

Cognitive Behaviour Therapy BEHAVIORAL

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bristol: lead
• Diabetes UK: collaborator

Study Sites (1)

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elizabeth C Crowne, MD

  UBHT

  PRINCIPAL INVESTIGATOR

• Ruth J Allen, PhD

  University of Bristol

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 3, 2006
• Study Start: September 1, 2001
• Study Completion: June 1, 2005
• Last Updated: August 3, 2006

Record last verified: 2001-06

Locations

GB (1)