Mindfulness Training in Adolescents With Type 1 Diabetes | NCT06140030

Studies
Mindfulness Training in Adolescents With Type 1 Diabetes

NCT06140030

Sponsor

University of South Florida

Status

Unknown status

Last Update Posted

Dec 7, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Anxiety
Type 1 Diabetes
Quality of Life

Interventions

Mindfulness training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2023

Last Update Posted Date

Dec 7, 2023Actual

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness training mobile health application	Experimental	Use of a mindfulness training mobile health application	Behavioral: Mindfulness training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness training	Behavioral	Mindfulness-training mobile health application	Mindfulness training mobile health application

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Glycemic control	HbA1c

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida College of Nursing	Recruiting	Tampa	Florida	33612	United States

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D001523	Mental Disorders
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided