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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: An Internet Cognitive-Behavioral Intervention

• Registration Number: NCT02361606
• Lead Sponsor: Dr. Orit Hamiel

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-02
• Study Completion: 2013-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet CBT intervention	An Internet Cognitive-Behavioral Intervention	Eligible candidates were offered to participate in an internet cognitive behavioral intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in glycemic control. (HbaA1c levels, obtained from medical records)	Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).	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.