University of California, San Diego
San Diego, California, 92037, United States
Location status: Recruiting
Location contact
Amalia Axinn, BA
CONTACT
Edward C Chao, DO
PRINCIPAL_INVESTIGATOR
Edward Chao, DO
CONTACT
619-400-5050 ext. Chao
NCT Number: NCT06398093
There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92037, United States
Location status: Recruiting
Amalia Axinn, BA
CONTACT
Edward C Chao, DO
PRINCIPAL_INVESTIGATOR
Edward Chao, DO
CONTACT
619-400-5050 ext. Chao
A pre-test and post-test experimental design will be used to evaluate the efficacy of the self-compassion tool kit on distress, coping, testing glucose, sleep, and wellness in adults living with T2D.
For this 4-week study, participants will receive education on Sleep Hygiene practices during the first week of the intervention. Mindfulness meditation will be offered to participants using the Headspace app and four, ten-minute sessions will be prescribed per week. For exercise, 30-60 minutes of daily physical activity will be prescribed and participants can select the exercise of their choice. Additionally, participants will receive a journal in the mail with prompts associated with each day of required journalling. Prompts will elicit reflections, gratitude and growth. Participants will be followed by telephone every week. Baseline and week four data will be collected using the Demographic Form, T2DDAS, the Pittsburgh Sleep Quality Index (PSQI) and the SF-20. In addition, participants will be instructed to maintain a glucose testing, meditation, and exercise adherence log. The glucose testing log will permit measuring consistency and adherence to treatment over the course of the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks.
Time frame: 4 weeks
Will assess for change pre and post-intervention on standardized questionnaires on diabetes distress and self-compassion scores after the intervention.
Contact information is provided by the study sponsor or research team.
Amalia Axinn, BS
CONTACT
Edward C Chao, DO
CONTACT
University of California, San Diego
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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