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Behavioral Intervention
Mindfulness Training for Type 1 Diabetes Anxiety
N/A
Recruiting
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Type 1 diabetes > 6 months
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a mobile app designed to help teens with Type 1 diabetes reduce anxiety through regular mindfulness exercises. The app aims to improve their mental health by teaching them to focus on the present moment and manage stress better.
Who is the study for?
This trial is for adolescents who have been living with Type 1 diabetes for more than six months, can read and speak English fluently, and are experiencing some anxiety as indicated by a GAD-7 score greater than five.
What is being tested?
The study is testing a mobile health app that provides mindfulness training. The goal is to see if practicing mindfulness daily can help reduce anxiety symptoms in these young individuals with Type 1 diabetes.
What are the potential side effects?
Mindfulness training typically does not involve physical side effects but may bring up emotional discomfort or distress as participants become more aware of their thoughts and feelings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had Type 1 diabetes for more than 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety Symptoms
Secondary study objectives
Diabetes-specific quality of life
Glycemic control
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mindfulness training mobile health applicationExperimental Treatment1 Intervention
Use of a mindfulness training mobile health application
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness training
2005
Completed Phase 3
~1920
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mindfulness-Based Stress Reduction (MBSR) and similar treatments improve Quality of Life (QoL) by employing mindfulness techniques such as meditation, deep breathing, and body awareness exercises. These methods work by reducing the body's stress response, lowering cortisol levels, and improving emotional regulation.
This leads to better mental health outcomes, including reduced anxiety and depression, which are essential for enhancing overall QoL. Additionally, these practices increase self-awareness and promote a sense of well-being, aiding patients in managing chronic conditions and improving daily functioning.
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,676 Total Patients Enrolled
University of South FloridaLead Sponsor
427 Previous Clinical Trials
192,591 Total Patients Enrolled