Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398093
• Other study ID #: 810394
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Amalia Axinn, BS
• Phone: 6194005050
• Email: aaxinn[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Distress
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Self-Compassion Tool Kit
Participants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Compassion	Will assess for change pre and post-intervention on standardized questionnaires on diabetes distress and self-compassion scores after the intervention.	4 weeks