Mindfulness Training for Type 1 Diabetes Anxiety

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Chronic condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mindfulness app can reduce anxiety in adolescents with Type 1 diabetes. Researchers aim to determine if daily use of this app can manage stress and improve overall mental well-being. Participants must have had Type 1 diabetes for at least six months and experience anxiety that impacts daily life. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health support for adolescents with Type 1 diabetes.

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 prior data suggests that this mindfulness training is safe for adolescents with Type 1 diabetes?

Research has shown that mindfulness training is safe for people with diabetes. Studies have found that mindfulness methods, such as Mindfulness-Based Stress Reduction (MBSR), can improve both mental and physical health in these individuals. These practices are generally safe and typically do not cause harm or negative effects.

In past studies with teenagers who have Type 1 diabetes, mindfulness training proved both acceptable and helpful. Young people could easily follow the program, which helped them manage stress and anxiety more effectively.

Mindfulness practices have been used safely for a long time across various groups, including those with different health conditions. Since this approach does not involve medication, there are no drug-related side effects. Overall, mindfulness training is considered a safe way to enhance mental health in teenagers with Type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for anxiety in people with Type 1 Diabetes involve psychological therapies like cognitive-behavioral therapy or medications that manage anxiety symptoms. However, the mindfulness training under study is unique because it uses a mobile health application to deliver mindfulness techniques, making it more accessible and convenient for users. This approach allows individuals to practice mindfulness anytime and anywhere, which could help integrate stress management into daily routines more easily. Researchers are excited because this method might offer a flexible and scalable way to reduce anxiety, potentially improving both mental well-being and diabetes management without the side effects often associated with medication.

What evidence suggests that mindfulness training might be an effective treatment for Type 1 diabetes anxiety?

Research shows that mindfulness training can reduce anxiety in people with Type 1 diabetes. In this trial, participants will use a mindfulness training mobile health application. Studies have found that mindfulness practices can lower stress and anxiety and may even aid in blood sugar control. Early results suggest improvements in mental health for young people with Type 1 diabetes. Mindfulness-based stress reduction has helped individuals adjust better to social and psychological challenges. These findings suggest that mindfulness training could be a useful tool for managing anxiety in teenagers with Type 1 diabetes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Training

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

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Efficacy of mindfulness-based stress reduction in emerging ... Results provide preliminary support for the efficacy of MBSR to improve psychosocial adjustment in emerging adults with poorly controlled T1D.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430895/

Effectiveness of Mindfulness-Based Interventions with ... Effectiveness of mindfulness-based interventions with respect to psychological and biomedical outcomes in young people with type 1 diabetes.

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Meta-Analytic Insights Into Mindfulness Approaches for ... Studies have shown that mindfulness practices reduce physiological stress responses, alleviate anxiety, and improve A1C and fasting blood ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213422025000186

Mindfulness-based interventions for adults with type 2 ... Mindfulness-based interventions (MBIs) may improve metabolic and psychological health in individuals with T2DM.

5. iaap-journals.onlinelibrary.wiley.com iaap-journals.onlinelibrary.wiley.com/doi/10.1111/aphw.12441

The effectiveness of mindfulness‐based stress reduction ... The findings suggest that MBSR appears to be an effective treatment for improving mental health conditions and mindfulness in people with diabetes.

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Mindfulness-Based Stress Reduction and Diabetes - PMC This review highlights the literature and research on Mindfulness-Based Stress Reduction to improve the health and well-being of individuals with diabetes.

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Mindfulness-based interventions for adults with type 2 ... Mindfulness-based interventions (MBIs) may improve metabolic and psychological health in individuals with T2DM.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03942471?tab=table

Mindfulness for Adolescents With Type 1 Diabetes The Effects of Learning Mindfulness Based Stress Reduction on Psychosocial Variables and HbA1c in Adolescents With Type 1 Diabetes. Brief Summary ...

9. formative.jmir.org formative.jmir.org/2024/1/e45659

Acceptability of a Self-Led Mindfulness-Based Intervention for ... Efficacy of mindfulness-based stress reduction in emerging adults with poorly controlled, type 1 diabetes: A pilot randomized controlled trial.

10. mdpi.com mdpi.com/2227-9032/12/18/1876

Effectiveness of Mindfulness-Based Interventions with ... Effectiveness of mindfulness-based interventions with respect to psychological and biomedical outcomes in young people with type 1 diabetes.