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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361606
• Other study ID #: 2009108
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: February 6, 2015
• Start date: March 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 20 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Orit Hamiel	Academic College of Tel Aviv-Jaffa, Maccabi Healthcare Services, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Youth expectations of the program. (Questionnaire regarding the expectations of the possible benefits of the program.)	Questionnaire regarding the expectations of the possible benefits of the program.	Baseline	No
Primary	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)	No
Primary	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)	No
Primary	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).	No
Secondary	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).	No