Mindfulness for Adolescents With Type 1 Diabetes

Duquesne University

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Mindfulness Based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03942471

2015/10/14

Details and patient eligibility

About

Adolescents with Type 1 Diabetes will be invited to the Mindfulness study. They will be randomly assigned to a Control or Active Group. The Active Group will learn Mindfulness Based Stress Reduction (MBSR) through an online website designed to teach the basic principles of MBSR in six week-long modules. They will be measured in three main areas: before learning the intervention, directly after learning it and 3 months after learning it to determine any changes in their Mindful attention awareness, Diabetes Quality of Life and HbA1c. The Control Group will also take the questionnaires at the beginning of the study, 6 weeks after it begins and then 3 months from the beginning to obtain data for all three time points when they have not received access to the modules/intervention.

Full description

Research Design and Procedures This study will utilize a between group repeated measures design to measure the effects of the learned MBSR intervention over time. MBSR will be the independent variable. Dependent variables include mindfulness, diabetic quality of life and HbA1c. Adolescents with Type 1 diabetes will be randomly assigned to an intervention group or a wait list/control group that will be taught MBSR after all data has been collected. The study will utilize a 2 (experimental versus wait-list control group) by 3 (pretest [Time 1], posttest [Time 2], and 3 month follow-up [Time 3]) to examine within and between group differences overtime on two psychosocial measures including mindfulness and quality of life. The physiological measure understudy, HbA1c, reflects glucose control over the previous three month period and will be measured at Time 1 and Time 3. MBSR training will be provided via an online website and secure data collection site called MySweetMind.org.

Enrollment: 65 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adolescents between the ages of 12 - 19
• Diagnosis of Type 1 Diabetes
• Fluent in English
• No diagnosed cognitive impairments
• 6th grade education completion
• Access to a Computer
• Access to the internet

Exclusion Criteria: under 12, over 19 - no access to a computer/internet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Intervention Mindfulness Based Stress Reduction

Other group

Description:

Six Modules each delivering an important principle of Mindfulness Based Stress Reduction

Treatment:

Behavioral: Mindfulness Based Stress Reduction

Control Group

No Intervention group

Description:

Wait Group - received no mindfulness teaching