Mindfulness Training in Adolescents With Type 1 Diabetes

Sponsor

University of South Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT06140030

Collaborator

National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Type 1 Diabetes Quality of Life	Behavioral: Mindfulness training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness training mobile health application Use of a mindfulness training mobile health application	Behavioral: Mindfulness training Mindfulness-training mobile health application

Arm

Intervention/Treatment

Experimental: Mindfulness training mobile health application

Use of a mindfulness training mobile health application

Behavioral: Mindfulness training

Mindfulness-training mobile health application

Outcome Measures

Primary Outcome Measures

Anxiety Symptoms [12 weeks]
Generalized anxiety disorder - 7

Secondary Outcome Measures

Diabetes-specific quality of life [12 weeks]
Pediatric quality of life inventory, diabetes-specific
Glycemic control [12 weeks]
HbA1c

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Type 1 diabetes > 6 months; reads and speaks English fluently; GAD-7 score > 5 -

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida College of Nursing	Tampa	Florida	United States	33612

Sponsors and Collaborators

University of South Florida
National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of South Florida

ClinicalTrials.gov Identifier:

NCT06140030

Other Study ID Numbers:

K23NR019911-03

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 18, 2023