An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy

Study Overview
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Brief Summary
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Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.

Detailed Description
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Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life. Single center study was conducted to describe participation and efficacy of internet cognitive-behavioral intervention for youth with type 1 diabetes. Adolescents with type 1 diabetes, aged 13-20 years, treated at a Juvenile Diabetes Center, were offered to participate in the intervention. Recruitment period lasted for 2 months, during January-February, 2011. HbA1c measures of adolescents that agreed to participate, were obtained from medical records.The adolescents, that logged in, were asked to complete questionnaires before the intervention assessing their expectations of the program, quality of life and parental support. After completion of questionnaires, the adolescents were encouraged to complete 6 virtual sessions. Satisfaction was assessed after each session. In the end of the program, participants were asked again to complete questionnaires. HbA1c levels were obtained again for participants that logged in, and for participants that passively refused, 3 months or more after the recruitment.

Official Title
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An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: An Internet Cognitive-Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis with diabetes for at least 1 year treated at Juvenile Diabetes Center fluent Hebrew speakers Exclusion Criteria: no previous diagnosis of a psychiatric condition (such as an eating disorder) no opposition to the internet due to religious issues.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet CBT intervention<br>Eligible candidates were offered to participate in an internet cognitive behavioral intervention. | Behavioral: An Internet Cognitive-Behavioral Intervention<br>* We developed a cognitive behavioral program for adolescents with type 1 Diabetes and their parents, that consists of six virtual sessions at https://minustress.com/diabetes/gate.asp.<br>* Other names: An Internet CBT for Youth with Type 1 Diabetes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire) | Filled in the intervention website. | Change from baseline to the end of intervention (3 to 6 months from baseline) | 
| Perceived parent support. (Short version of the Social Provision Scale) | Short version of the Social Provision Scale -filled in the intervention website. | Change from baseline to the end of intervention (3 to 6 monts) | 
| Youth satisfaction of the program. (Questionnaire regarding the degree that the session was helpful.) | Questionnaire regarding the degree that the session was helpful. | Measured at the end of every virtual session (2 days to 6 months from baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control. (HbaA1c levels, obtained from medical records) | HbaA1c levels, obtained from medical records twice - the closest measurement available before the trial period, and closest measurement available 3 months or more after the trial period. | Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, cognitive behavioral internet intervention