Back to resultsCBT in Adolescents With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behaviour Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Adolescents, Cognitive Behaviour Therapy
Eligibility 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
Sites / Locations
- Bristol Royal Hospital for Children
Outcomes
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).
Full Information
NCT ID
NCT00360061
First Posted
August 1, 2006
Last Updated
August 1, 2006
Sponsor
University of Bristol
Collaborators
Diabetes UK
1. Study Identification
Unique Protocol Identification Number
NCT00360061
Brief Title
CBT in Adolescents With Type 1 Diabetes
Official Title
Randomised Controlled Trial of Cognitive Behaviour Therapy: Efficacy and Acceptability for Adolescents With Type 1 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2001
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bristol
Collaborators
Diabetes UK
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Adolescents, Cognitive Behaviour Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behaviour Therapy
Primary Outcome Measure Information:
Title
HBA1c
Secondary Outcome Measure Information:
Title
Well Being Questionnaire, Children's Health locus of control,
Title
Diabetes Quality of Life for Youths (modified from DCCT),
Title
Self Efficacy for Diabetes Scale (modified version,),
Title
Diabetes Family Behaviour Scale, Diabetes Readiness to Change Questionnaire,
Title
Modified Health Care Climate Questionnaire (at baseline only).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Crowne, MD
Organizational Affiliation
UBHT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruth J Allen, PhD
Organizational Affiliation
University of Bristol
Official's Role
Study Chair
Facility Information:
Facility Name
Bristol Royal Hospital for Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
CBT in Adolescents With Type 1 Diabetes
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