NCT06140030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

November 14, 2023

Last Update Submit

November 30, 2023

Conditions

AnxietyType 1 DiabetesQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Anxiety Symptoms

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

    12 weeks

Secondary Outcomes (2)

  • Diabetes-specific quality of life

    12 weeks

  • Glycemic control

    12 weeks

Study Arms (1)

Mindfulness training mobile health application

EXPERIMENTAL

Use of a mindfulness training mobile health application

Behavioral: Mindfulness training

Interventions

Mindfulness trainingBEHAVIORAL

Mindfulness-training mobile health application

Mindfulness training mobile health application

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical diagnosis of a chronic medical condition requiring intensive daily management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida College of Nursing

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Mental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

October 1, 2023

Primary Completion

March 1, 2025

Study Completion

December 1, 2025

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

US(1)