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Clinical Trials/NCT06140030
NCT06140030
Recruiting
Not Applicable

Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes

University of South Florida1 site in 1 country40 target enrollmentOctober 1, 2023
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ConditionsAnxietyType 1 DiabetesQuality of Life

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of South Florida
Enrollment
40
Locations
1
Primary Endpoint
Anxiety Symptoms
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
December 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Anxiety Symptoms

Time Frame: 12 weeks

Generalized Anxiety Disorder 7-item Score range: 0 to 21 Higher scores indicate more anxiety

Secondary Outcomes

  • Diabetes-specific quality of life(12 weeks)
  • Glycemic control(12 weeks)

Study Sites (1)

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