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

NCT ID: NCT02361606

Last Updated: 2015-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Internet CBT intervention

Eligible candidates were offered to participate in an internet cognitive behavioral intervention.

Group Type EXPERIMENTAL

An Internet Cognitive-Behavioral Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Minustress For Type 1 Diabetes Program An Internet CBT for Youth with Type 1 Diabetes

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academic College of Tel Aviv-Jaffa

OTHER

Sponsor Role collaborator

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role collaborator

Dr. Orit Hamiel

OTHER_GOV

Sponsor Role lead

Responsible Party

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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

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Orit Pinhas Hamiel, MD

Role: STUDY_DIRECTOR

Sheba Medical Center

Daniel Hamiel, PhD

Role: STUDY_DIRECTOR

The Interdisciplinary Center

Irena Vusiker, MA

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Other Identifiers

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2009108

Identifier Type: -

Identifier Source: org_study_id

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