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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
Sponsor:
Collaborators:
Academic College of Tel Aviv-Jaffa
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Dr. Orit Hamiel, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE February 3, 2015
First Posted Date  ICMJE February 12, 2015
Last Update Posted Date February 12, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2015)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
Official Title  ICMJE An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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.
Other Names:
  • Minustress For Type 1 Diabetes Program
  • An Internet CBT for Youth with Type 1 Diabetes
Study Arms  ICMJE Experimental: Internet CBT intervention
Eligible candidates were offered to participate in an internet cognitive behavioral intervention.
Intervention: Behavioral: An Internet Cognitive-Behavioral Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2015)
89
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02361606
Other Study ID Numbers  ICMJE 2009108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Orit Hamiel, Sheba Medical Center
Study Sponsor  ICMJE Dr. Orit Hamiel
Collaborators  ICMJE
  • Academic College of Tel Aviv-Jaffa
  • Maccabi Healthcare Services, Israel
Investigators  ICMJE
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
PRS Account Sheba Medical Center
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP