NCT02361606

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

February 3, 2015

Last Update Submit

February 6, 2015

Conditions

Type 1 Diabetes

Keywords

adolescentscognitive behavioral internet intervention

Outcome Measures

Primary Outcomes (3)

  • Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)

    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)

    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.)

    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 Outcomes (1)

  • Change in glycemic control. (HbaA1c levels, obtained from medical records)

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

Other Outcomes (1)

  • Youth expectations of the program. (Questionnaire regarding the expectations of the possible benefits of the program.)

    Baseline

Study Arms (1)

Internet CBT intervention

EXPERIMENTAL

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

Behavioral: An Internet Cognitive-Behavioral Intervention

Interventions

An Internet Cognitive-Behavioral InterventionBEHAVIORAL

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.

Also known as: Minustress For Type 1 Diabetes Program, An Internet CBT for Youth with Type 1 Diabetes
Internet CBT intervention

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis with diabetes for at least 1 year
  • treated at Juvenile Diabetes Center
  • fluent Hebrew speakers

You may not qualify if:

  • no previous diagnosis of a psychiatric condition (such as an eating disorder)
  • no opposition to the internet due to religious issues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Orit Pinhas Hamiel, MD

    Sheba Medical Center

    STUDY DIRECTOR

  • Daniel Hamiel, PhD

    The Interdisciplinary Center

    STUDY DIRECTOR

  • Irena Vusiker, MA

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist in Pediatric Endocrinology, Pediatric Endocrinology and Juvenile Deibetes Head Department, Sheba Medical Center; Head of Juvenile Diabetes Center, Maccabi Health Services

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 12, 2015

Study Start

March 1, 2009

Primary Completion

February 1, 2011

Study Completion

January 1, 2013

Last Updated

February 12, 2015

Record last verified: 2015-02