Mindfulness Training in Adolescents With Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes; Quality of Life; Anxiety
• Interventions: Behavioral: Mindfulness training

• Registration Number: NCT06140030
• Lead Sponsor: University of South Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07
• Primary Completion: 2025-03-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• Clinical diagnosis of a chronic medical condition requiring intensive daily management

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness training mobile health application	Mindfulness training	Use of a mindfulness training mobile health application

Primary Outcome Measures

Name	Time	Method
Anxiety Symptoms	12 weeks	Generalized Anxiety Disorder 7-item Score range: 0 to 21 Higher scores indicate more anxiety

Secondary Outcome Measures

Name	Time	Method
Diabetes-specific quality of life	12 weeks	Pediatric Quality of Life Inventory 3.2 Diabetes Module Range 0 to 100 Higher scores indicate better quality of life
Glycemic control	12 weeks	HbA1c

Trial Locations

Locations (1)

University of South Florida College of Nursing; 🇺🇸 Tampa, Florida, United States