Clinical trial NCT02361606: An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
Official title: An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: adolescents
cognitive behavioral internet intervention
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Academic College of Tel Aviv-Jaffa
name: Maccabi Healthcare Services, Israel
First posted: 2015-02-12
Enrollment: 89
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)
timeFrame: Change from baseline to the end of intervention (3 to 6 months from baseline)
measure: Perceived parent support. (Short version of the Social Provision Scale)
timeFrame: Change from baseline to the end of intervention (3 to 6 monts)
measure: Youth satisfaction of the program. (Questionnaire regarding the degree that the session was helpful.)
timeFrame: Measured at the end of every virtual session (2 days to 6 months from baseline).
Secondary outcomes:
measure: Change in glycemic control. (HbaA1c levels, obtained from medical records)
timeFrame: Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).
Other outcomes:
measure: Youth expectations of the program. (Questionnaire regarding the expectations of the possible benefits of the program.)
timeFrame: Baseline
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Orit Pinhas Hamiel, MD
role: STUDY_DIRECTOR
affiliation: The Interdisciplinary Center
name: Daniel Hamiel, PhD
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Irena Vusiker, MA
role: PRINCIPAL_INVESTIGATOR
References: