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NCT06140030 Clinical Trial

Mindfulness Training in Adolescents With Type 1 Diabetes

Anxiety Clinical Trial

Official title:
Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06140030
Other study ID # STUDY004827
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date December 1, 2025

Study information
Verified date November 2023
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with Type 1 diabetes. Aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with Type 1 diabetes.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 19 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Type 1 diabetes for 6 months or longer - Anxiety score of 5 or higher on the Generalized Anxiety Disorder 7-item scale - Must be able to read and speak English Exclusion Criteria: - Clinical diagnosis of a chronic medical condition requiring intensive daily management

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mindfulness training
Mindfulness-training mobile health application

Locations
Country Name City State
United States University of South Florida College of Nursing Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
University of South Florida National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety Symptoms Generalized Anxiety Disorder 7-item Score range: 0 to 21 Higher scores indicate more anxiety 12 weeks
Secondary Diabetes-specific quality of life Pediatric Quality of Life Inventory 3.2 Diabetes Module Range 0 to 100 Higher scores indicate better quality of life 12 weeks
Secondary Glycemic control HbA1c 12 weeks
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