Anxiety Clinical Trial
Official title:
Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes
Verified date | November 2023 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida College of Nursing | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Institute of Nursing Research (NINR) |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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