An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
An Internet Cognitive-Behavioral Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring adolescents, cognitive behavioral internet intervention
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet CBT intervention
Arm Description
Eligible candidates were offered to participate in an internet cognitive behavioral intervention.
Outcomes
Primary Outcome Measures
Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)
Filled in the intervention website.
Perceived parent support. (Short version of the Social Provision Scale)
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.)
Questionnaire regarding the degree that the session was helpful.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02361606
First Posted
February 3, 2015
Last Updated
February 6, 2015
Sponsor
Dr. Orit Hamiel
Collaborators
Academic College of Tel Aviv-Jaffa, Maccabi Healthcare Services, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02361606
Brief Title
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
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Orit Hamiel
Collaborators
Academic College of Tel Aviv-Jaffa, Maccabi Healthcare Services, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
adolescents, cognitive behavioral internet intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet CBT intervention
Arm Type
Experimental
Arm Description
Eligible candidates were offered to participate in an internet cognitive behavioral intervention.
Intervention Type
Behavioral
Intervention Name(s)
An Internet Cognitive-Behavioral Intervention
Other Intervention Name(s)
Minustress For Type 1 Diabetes Program, An Internet CBT for Youth with Type 1 Diabetes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)
Description
Filled in the intervention website.
Time Frame
Change from baseline to the end of intervention (3 to 6 months from baseline)
Title
Perceived parent support. (Short version of the Social Provision Scale)
Description
Short version of the Social Provision Scale -filled in the intervention website.
Time Frame
Change from baseline to the end of intervention (3 to 6 monts)
Title
Youth satisfaction of the program. (Questionnaire regarding the degree that the session was helpful.)
Description
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).
Secondary Outcome Measure Information:
Title
Change in glycemic control. (HbaA1c levels, obtained from medical records)
Description
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.
Time Frame
Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).
Other Pre-specified Outcome Measures:
Title
Youth expectations of the program. (Questionnaire regarding the expectations of the possible benefits of the program.)
Description
Questionnaire regarding the expectations of the possible benefits of the program.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orit Pinhas Hamiel, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Hamiel, PhD
Organizational Affiliation
The Interdisciplinary Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Irena Vusiker, MA
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
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