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Mindfulness Training in Adolescents With Type 1 Diabetes

NCT ID: NCT06140030

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Anxiety Type 1 Diabetes Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness training mobile health application

Use of a mindfulness training mobile health application

Group Type EXPERIMENTAL

Mindfulness training

Intervention Type BEHAVIORAL

Mindfulness-training mobile health application

Interventions

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Mindfulness training

Mindfulness-training mobile health application

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of South Florida College of Nursing

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Kaitlyn Rechenberg, PhD

Role: primary

Other Identifiers

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STUDY004827

Identifier Type: -

Identifier Source: org_study_id