Clinical trial NCT06398093: Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
Official title: Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Diabetes Distress
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Has type 2 diabetes
* Has a score above 2 on the T2D Distress Assessment Scale

Exclusion Criteria:

* Does not have type 2 diabetes
* Has a score above 2 on the T2D Distress Assessment Scale
* Cannot safely exercise
* Cannot complete the requested tasks

Primary outcomes:
measure: Self-Compassion
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Edward C Chao, DO
role: PRINCIPAL_INVESTIGATOR
References: