Digital Mindfulness for Young Adults With Type 1 Diabetes

Yale University10 enrolled

Overview

The purpose of this research study is to test a mindfulness app called Calm Health among young adults with type 1 diabetes or other absolute insulin deficiency diabetes. Mindfulness is the practice of being aware of your thoughts and feelings in the moment without judgment or negative reaction. All participants will receive mindfulness guidance and personalized feedback about the relationship among your mindfulness, blood sugar, stress, and sleep.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes (T1D)Diabetes Secondary to Pancreatitis

Interventions

Mindfulness appBEHAVIORAL

Mindfulness app called Calm Health. It has mindfulness guidance modules related to different aspects of physical and mental health, including type 1 diabetes. It also provides a final report to help you track the relationship between mindfulness and your blood sugar, stress, and sleep.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Receiving diabetes care at Yale New Haven Children's Hospital or Yale New Haven Hospital. 2. Sign and date informed consent form we will provide 3. Willingness to complete procedures and availability for duration of the study 4. Aged 18-30 years 5. Diagnosed with type 1 diabetes (T1D) or other absolute insulin deficiency diabetes (latent autoimmune diabetes of adulthood, diabetes secondary to pancreatitis) for at least 1 year. 6. User of a continuous glucose monitor (CGM) in your routine clinical care for at least the past 2 weeks. 7. Able to use a smartphone. 8. Able to read and write English. Exclusion Criteria: 1. Current meditation or mindfulness practice meeting or exceeding the study's recommended schedule 2. Current severe untreated psychiatric illness (e.g., bipolar disorder, schizophrenia, major depression, panic disorder, borderline personality disorder, organic mood or mental disorders) or active suicidal ideation 3. New or unstable psychopharmaceutical treatment in past 2 months. 4. Current or planned pregnancy during study period.

Locations (1)

Yale University School of Medicine

New Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Mindfulness app usage

Minutes of usage per week

Time frame: 6 weeks

Secondary Outcomes

Exit survey

Likert-style survey of usability, acceptability, appropriateness, and feasibility. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)

Time frame: 6 weeks

T1D-related emotional distress

Problem Areas in Diabetes (PAID) scale. Responses are on a scale from 0 (Not a problem) to 4 (serious problem)

Time frame: 6 weeks

Type 1 Diabetes Distress

Type 1 Diabetes Distress Scale (T1-DDS). Consists of common distressing things about living with type 1 diabetes. Scores range from 1 (not a problem) to 6 (very serious problem).

Time frame: 6 weeks

Type 1 diabetes-specific health related quality of life

Type 1 diabetes and life (T1DAL) scale. Aspects of life with type 1 diabetes. Scores range from 1 (no, not true at all) to 5 (yes, very true).

Time frame: 6 weeks

Anxiety

Generalized anxiety disorder 7-question screener (GAD-7). Participants rate frequency of symptoms. Scores range from 0 (not at all) to 3 (nearly every day).

Time frame: 6 weeks

Depression

Patient Health Questionnaire 9-question screener. Participants rate frequency of symptoms. Scores range from 0 (not at all) to 3 (nearly every day).

Time frame: 6 weeks

Central Contacts

Laura M Nally, MD

CONTACT

203-785-5831 laura.nally@yale.edu

Data from ClinicalTrials.gov

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