search
Back to results

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
Dr. Orit Hamiel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring adolescents, cognitive behavioral internet intervention

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    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
    search

    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

    We'll reach out to this number within 24 hrs