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Trial record 7 of 2791 for:    Type 1 Diabetes

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:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Type 1 Diabetes Behavioral: An Internet Cognitive-Behavioral Intervention

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
Study Start Date : March 2009
Primary Completion Date : February 2011
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Internet CBT intervention
Eligible candidates were offered to participate in an internet cognitive behavioral 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.
Other Names:
  • Minustress For Type 1 Diabetes Program
  • An Internet CBT for Youth with Type 1 Diabetes


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361606


Sponsors and Collaborators
Dr. Orit Hamiel
Academic College of Tel Aviv-Jaffa
Maccabi Healthcare Services, Israel
Investigators
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
More Information

Responsible Party: Dr. Orit Hamiel, Specialist in Pediatric Endocrinology, Pediatric Endocrinology and Juvenile Deibetes Head Department, Sheba Medical Center; Head of Juvenile Diabetes Center, Maccabi Health Services, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02361606     History of Changes
Other Study ID Numbers: 2009108
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Dr. Orit Hamiel, Sheba Medical Center:
adolescents
cognitive behavioral internet intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases