Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06398093

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Amalia Axinn, BA

CONTACT

[email protected]

Edward C Chao, DO

PRINCIPAL_INVESTIGATOR

Edward Chao, DO

CONTACT

[email protected]

619-400-5050 ext. Chao

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Compassion Tool Kit

Behavioral

Participants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks.

Primary outcomes

  1. Self-Compassion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amalia Axinn, BS

CONTACT

[email protected]

6194005050

Edward C Chao, DO

CONTACT

[email protected]

619-400-5050

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.