Mindfulness Training for Type 1 Diabetes Anxiety
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
13567How 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.
12348Eligibility 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Mindfulness training mobile health applicationExperimental Treatment1 Intervention
Use of a mindfulness training mobile health application
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of South Florida College of NursingTampa, FL
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Who Is Running the Clinical Trial?
University of South FloridaLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
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]Mindfulness-based interventions can successfully target negative perseverative cognitions such as worry and thought suppression, but their acceptability and effectiveness in people with long-term conditions is uncertain. We therefore pilot tested a six-week meditation and mindfulness intervention in people (n = 40) with diabetes mellitus and coronary heart disease. We used a sequential mixed-methods approach that measured change in worry and thought suppression and qualitatively explored acceptability, feasibility, and user experience with a focus group (n = 11) and in-depth interviews (n = 16). The intervention was highly acceptable, with 90% completing ≥5 sessions. Meditation and mindfulness skills led to improved sleep, greater relaxation, and more-accepting approaches to illness and illness experience. At the end of the six-week meditation course, worry, and thought suppression were significantly reduced. Positive impacts of mindfulness-based interventions on psychological health may relate to acquisition and development of meta-cognitive skills but this needs experimental confirmation.
Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial. [2022]The DiaMind trial showed beneficial immediate effects of mindfulness-based cognitive therapy (MBCT) on emotional distress, but not on diabetes distress and HbA1c. The aim of the present report was to examine if the effects would be sustained after six month follow-up.
The association between mindfulness and emotional distress in adults with diabetes: could mindfulness serve as a buffer? Results from Diabetes MILES: The Netherlands. [2022]People with diabetes have a higher risk of emotional distress (anxiety, depression) than non-diabetic or healthy controls. Therefore, identification of factors that can decrease emotional distress is relevant. The aim of the present study was to examine (1) the association between facets of mindfulness and emotional distress; and (2) whether mindfulness might moderate the association between potential adverse conditions (stressful life events and comorbidity) and emotional distress. Analyses were conducted using cross-sectional data (Management and Impact for Long-term Empowerment and Success--Netherlands): 666 participants with diabetes (type 1 or type 2) completed measures of mindfulness (Five Facet Mindfulness Questionnaire-Short Form; FFMQ-SF), depressive symptoms (Patient Health Questionnaire; PHQ-9), and anxiety symptoms (General Anxiety Disorder assessment; GAD-7). Hierarchical multiple regression analyses showed significant associations between mindfulness facets (acting with awareness, non-judging, and non-reacting) and symptoms of anxiety and depression (β = -0.20 to -0.33, all p
Feasibility of Mindfulness-Based Stress Reduction for Older Adolescents and Young Adults with Poorly Controlled Type 1 Diabetes. [2022]The purpose of the study was to assess the acceptability and feasibility of Mindfulness-Based Stress Reduction (MBSR), a group-delivered intervention, to reduce stress and improve illness management among urban, older adolescents and young adults with poorly controlled type 1 diabetes (T1D).
Effects of Mind-Body Training as a Mental Health Therapy in Adults with Diabetes Mellitus Type II: A Systematic Review. [2023]The increase in the prevalence and disease burden of diabetes has highlighted the need to strengthen a comprehensive care system that includes mental health treatment. A systematic review was carried out to analyze the effectiveness of mind-body training as a therapy for the mental health management of adult patients with type 2 diabetes mellitus (T2DM) following the PRISMA 2020 guidelines. Pubmed, Scopus and Web of Science databases were consulted between November and December 2022. Eight articles were selected according to the inclusion and exclusion criteria. Only randomized controlled trials were included. The interventions focused on mindfulness and yoga with variable durations of between 8 weeks and 6 months. Four of the included studies observed statistically significant changes (p < 0.05) in anxiety. Six articles determined that mind-body training was effective for treating depression. Finally, five articles found favorable effects on stress, while one did not observe changes at 8 weeks of intervention or after 1 year of follow-up. The evidence supports the use of mind-body training to reduce stress, depression, and anxiety levels in the adult population with T2DM, which makes this type of training a valuable intervention to be included in an integral approach to diabetic pathology.
Mind-Body Interactions and Mindfulness Meditation in Diabetes. [2022]Diabetes is associated with significant psychological distress. It is, therefore, important to ensure the physical and emotional as well as psychosocial wellbeing of individuals living with diabetes. Meditation-based strategies have been evaluated for their complementary role in several chronic disorders including depression, anxiety, obesity, hypertension, cardiovascular disease and diabetes. The practice of meditation is associated with reduction in stress and negative emotions and improvements in patient attitude, health-related behaviour and coping skills. There is increased parasympathetic activity with reduction in sympathetic vascular tone, stress hormones and inflammatory markers. Additionally, several studies evaluated the role of mindfulness-based stress reduction in diabetic individuals and demonstrated modest improvements in body weight, glycaemic control and blood pressure. Thus, mindfulness meditation-based intervention can lead to improvements across all domains of holistic care - biological, psychological and social. Though most of these studies have been of short duration and included small numbers of patients, meditation strategies can be useful adjunctive techniques to lifestyle modification and pharmacological management of diabetes and help improve patient wellbeing.
A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. [2022]To investigate the feasibility of delivering a low-dose mindfulness-based stress reduction (MBSR) intervention among prediabetes/diabetes patients in a clinical setting.
Mindfulness in adolescents and young adults with diabetes: An integrative review. [2022]Type 1 diabetes (T1D), type 2 diabetes, and prediabetes are increasing in incidence. Adolescents and young adults with diabetes experience psychosocial comorbidities at an increased incidence. As such, exploring interventions that can improve psychosocial and glycemic outcomes are needed. The purpose of this integrative review is to examine and synthesize the literature on mindfulness in adolescents and young adults with type 1 or type 2 diabetes or prediabetes.