An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
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|ClinicalTrials.gov Identifier: NCT02361606|
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : February 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: An Internet Cognitive-Behavioral Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||January 2013|
Experimental: Internet CBT intervention
Eligible candidates were offered to participate in an internet cognitive behavioral intervention.
Behavioral: An Internet Cognitive-Behavioral Intervention
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.
- Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire) [ Time Frame: 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) [ Time Frame: 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.) [ Time Frame: Measured at the end of every virtual session (2 days to 6 months from baseline). ]Questionnaire regarding the degree that the session was helpful.
- Change in glycemic control. (HbaA1c levels, obtained from medical records) [ Time Frame: 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.
- Youth expectations of the program. (Questionnaire regarding the expectations of the possible benefits of the program.) [ Time Frame: Baseline ]Questionnaire regarding the expectations of the possible benefits of the program.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361606
|Study Director:||Orit Pinhas Hamiel, MD||Sheba Medical Center|
|Study Director:||Daniel Hamiel, PhD||The Interdisciplinary Center|
|Principal Investigator:||Irena Vusiker, MA||Sheba Medical Center|