Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of diabetes management training combined with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range 13-20 years) compared to a control group. The investigators assess motivational changes and effects on metabolic control.

Detailed Description
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Diabetes mellitus type1 requires lifelong insulin substitution, aiming at near normal glycaemia. Insufficient metabolic control (HbA1c > 8 %) leads to micro and macro- vascular complications. Especially in adolescence a lack of compliance leads to deteriorated metabolic control. Motivational factors play a pivotal role in this age-group, however they have neither been studied so far nor considered in interventions with diabetes patients. Therefore, the aim of this study is to evaluate in a multi-centred randomized controlled trial the effectiveness of diabetes management training with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support. Sixty adolescents within the age group of 13-20 years and HbA1c levels > 8 % will - after a refresher course in diabetes education - be involved to 2-weekly individual interventions sessions including motivational interviewing and CBT-modules with a psychologist and weekly e-mail support for a period of six month in order to improve HbA1c levels, self- efficacy in diabetes management and general quality of life. As control group sixty adolescents within the age group of 13-20 years and HbA1c levels > 8 will - after a refresher course in diabetes education - get treatment as usual, including routine medical support visits, unspecific psychological consultations and unspecific e-mail support to match with the intervention group for time bonus. We assess motivational changes and effects on metabolic control (HbA1c) and define the predictors of positive effects on glycaemic control.

Official Title
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Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Motivational Interviewing, CBT and E-mail support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus, type1 HbA1c>8 1 year of diagnosis Access to Internet available Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational Interviewing, CBT and E-mail support<br> | Behavioral: Motivational Interviewing, CBT and E-mail support<br>* Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support<br>* Other names: Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents;|
| Active Comparator: E-Mail-support<br> | Behavioral: Motivational Interviewing, CBT and E-mail support<br>* Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support<br>* Other names: Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C | Metabolic control | after 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of positive effects on glycaemic control |  | after 6 months and after 12 months | 
| Motivational changes |  | after 6 months and 12 months | 
| HbA1c | Metabolic control | after 12 months |