What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) are generally considered safe with minimal side effects. However, some individuals may experience temporary increases in anxiety or emotional discomfort as they confront distressing thoughts and feelings during therapy. Additionally, relaxation-induced panic can occur in rare cases, where individuals feel increased anxiety during relaxation exercises. Overall, the benefits of these therapies in improving quality of life typically outweigh the risks.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at improving Quality of Life, particularly for conditions like anxiety and depression. While specific mindfulness-based stress reduction (MBSR) mobile health applications have not been explicitly approved, related treatments such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have been approved for managing anxiety and depression, which can significantly impact Quality of Life. These pharmacological treatments, including drugs like fluoxetine (Prozac) and venlafaxine (Effexor), are often used alongside non-pharmacological interventions like cognitive-behavioral therapy (CBT) to enhance overall well-being.

What other types of research exist?

Promising alternatives to MBSR mobile health applications for improving quality of life in patients include: 1) Cognitive Behavioral Therapy (CBT) delivered via digital platforms, which has shown high-quality evidence for short-term pain and stress reduction. 2) Acceptance and Commitment Therapy (ACT) delivered online, which has demonstrated efficacy in managing chronic pain and associated stress. 3) Guided imagery and progressive muscle relaxation techniques, which have been effective in reducing pain and improving psychological outcomes in cancer patients. 4) Telemedicine-based interventions, which have expanded access to care and shown positive outcomes in chronic disease management, including stress and anxiety reduction.

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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

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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

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

0 / 1Eligibility criteria met

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

598 Previous Clinical Trials

10,378,122 Total Patients Enrolled

University of South FloridaLead Sponsor

422 Previous Clinical Trials

189,187 Total Patients Enrolled

~12 spots leftby Mar 2025

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