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Completed

NCT Number: NCT02361606

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

An Internet Cognitive-Behavioral Intervention

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.

Other names: Minustress For Type 1 Diabetes Program, An Internet CBT for Youth with Type 1 Diabetes

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dr. Orit Hamiel

Other Gov

Collaborators

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

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Feb 12, 2015
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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