Mindfulness Training for Type 1 Diabetes Anxiety

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of South Florida

Disqualifiers: Chronic condition, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness training for anxiety in Type 1 diabetes, so it's best to ask the trial organizers for more details.

What data supports the effectiveness of the treatment Mindfulness Training for Type 1 Diabetes Anxiety?

Research shows that mindfulness-based interventions can help reduce worry and thought suppression in people with diabetes, leading to improved sleep and relaxation. Additionally, mindfulness practices have been associated with lower levels of anxiety and depression in people with diabetes, suggesting they may help manage emotional distress. ^{1 2 3 4 5}

Is mindfulness training safe for people with diabetes?

Mindfulness training, including meditation and mindfulness-based stress reduction, has been studied in people with diabetes and other conditions. It is generally considered safe and can lead to improvements in stress, anxiety, and overall well-being. Most studies report positive effects on mental health without significant safety concerns. ^{1 3 5 6 7}

How is mindfulness training different from other treatments for anxiety in type 1 diabetes?

Mindfulness training is unique because it focuses on improving emotional well-being by teaching skills like awareness and acceptance, which can reduce anxiety and stress. Unlike medications, it doesn't involve taking drugs and instead uses techniques like meditation to help manage emotional distress. ^{1 2 3 4 8}

Eligibility Criteria

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.

Inclusion Criteria

Your GAD-7 score is higher than 5.

Reads and speaks English fluently

I have had Type 1 diabetes for more than 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a mindfulness training mobile health application designed for adolescents with Type 1 diabetes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mindfulness Training (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Mindfulness training mobile health application Experimental Treatment 1 Intervention

Use of a mindfulness training mobile health application

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

A six-week mindfulness and meditation intervention was piloted with 40 participants who had diabetes or coronary heart disease, showing high acceptability with 90% completing at least 5 sessions.

The intervention significantly reduced worry and thought suppression, suggesting that mindfulness can improve psychological health by helping individuals develop better coping skills related to their illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-methods pilot study of the acceptability and effectiveness of a brief meditation and mindfulness intervention for people with diabetes and coronary heart disease. Keyworth, C., Knopp, J., Roughley, K., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) provided sustained reductions in perceived stress, anxiety, and depressive symptoms for up to six months in 139 outpatients with diabetes, demonstrating its effectiveness in improving emotional well-being.

However, MBCT did not significantly impact diabetes distress or glycemic control (HbA1c), indicating that while it helps with emotional issues, it may not directly address diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial. van Son, J., Nyklíček, I., Pop, VJ., et al.[2022]

In a study of 666 participants with diabetes, certain mindfulness traits (like acting with awareness and non-judging) were found to significantly reduce symptoms of anxiety and depression, indicating that mindfulness can be beneficial for emotional well-being in diabetic individuals.

Mindfulness also appeared to help buffer the negative effects of stressful life events on emotional distress, suggesting it could be a protective factor, although it did not significantly moderate the impact of comorbid health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between mindfulness and emotional distress in adults with diabetes: could mindfulness serve as a buffer? Results from Diabetes MILES: The Netherlands. van Son, J., Nyklíček, I., Nefs, G., et al.[2022]

Mindfulness-Based Stress Reduction (MBSR) was found to be highly acceptable and feasible for a small group of 10 older adolescents and young adults with poorly controlled type 1 diabetes, showing high satisfaction rates among participants.

Preliminary results suggest that MBSR may help reduce stress and improve blood glucose levels, indicating its potential as a supportive intervention for diabetes management, although further research in larger trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Stress Reduction for Older Adolescents and Young Adults with Poorly Controlled Type 1 Diabetes. Ellis, DA., Carcone, A., Slatcher, R., et al.[2022]

Mind-body training, including mindfulness and yoga, has been shown to significantly reduce anxiety, depression, and stress levels in adults with type 2 diabetes mellitus (T2DM), based on a systematic review of eight randomized controlled trials.

The interventions varied in duration from 8 weeks to 6 months, with four studies showing significant improvements in anxiety and six demonstrating effectiveness in treating depression, highlighting the importance of integrating mental health care into diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mind-Body Training as a Mental Health Therapy in Adults with Diabetes Mellitus Type II: A Systematic Review. Ruiz-Ariza, B., Hita-Contreras, F., Rodríguez-López, C., et al.[2023]

Meditation-based strategies can significantly reduce psychological distress in individuals with diabetes, leading to improvements in stress levels, emotional wellbeing, and coping skills.

Mindfulness meditation has shown modest benefits in managing diabetes-related health outcomes, such as body weight, glycaemic control, and blood pressure, making it a valuable complementary approach alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-Body Interactions and Mindfulness Meditation in Diabetes. Priya, G., Kalra, S.[2022]

A low-dose mindfulness-based stress reduction (MBSR) intervention was successfully delivered to prediabetes and diabetes patients, showing feasibility in a clinical setting with a recruitment rate of 55.9% and an attrition rate of 26.3%.

Participants experienced significant improvements post-intervention, including a reduction in depression scores, increased engagement in flexibility exercises, and a decrease in glycosylated hemoglobin (HbA1c) levels, indicating potential benefits for both mental and physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. Xia, T., Lopes, S., Chen, L., et al.[2022]

Mindfulness interventions have been found to be effective and acceptable for improving psychosocial and glycemic outcomes in adolescents and young adults with type 1 diabetes (T1D) and prediabetes, based on a review of 10 studies.

The review highlighted the need for further exploration of mobile health technology to enhance the feasibility of delivering mindfulness interventions, as no studies specifically addressed mindfulness in adolescents and young adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in adolescents and young adults with diabetes: An integrative review. Koerner, R., Rechenberg, K.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A mixed-methods pilot study of the acceptability and effectiveness of a brief meditation and mindfulness intervention for people with diabetes and coronary heart disease. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The association between mindfulness and emotional distress in adults with diabetes: could mindfulness serve as a buffer? Results from Diabetes MILES: The Netherlands. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Stress Reduction for Older Adolescents and Young Adults with Poorly Controlled Type 1 Diabetes. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Mind-Body Training as a Mental Health Therapy in Adults with Diabetes Mellitus Type II: A Systematic Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Mind-Body Interactions and Mindfulness Meditation in Diabetes. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness in adolescents and young adults with diabetes: An integrative review. [2022]