An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy

February 6, 2015 updated by: Dr. Orit Hamiel
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to the end of intervention (3 to 6 months from baseline)
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.
Change from baseline to the end of intervention (3 to 6 monts)
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.
Measured at the end of every virtual session (2 days to 6 months from baseline).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Orit Hamiel

Collaborators

Maccabi Healthcare Services, Israel
Academic College of Tel Aviv-Jaffa

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on An Internet Cognitive-Behavioral Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe