Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Jul 2024
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJuly 17, 2024
July 1, 2024
17 days
April 28, 2024
July 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Self-Compassion Toolkit
EXPERIMENTALInterventions
Participants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks.
Eligibility Criteria
You may qualify if:
- Has type 2 diabetes
- Has a score above 2 on the T2D Distress Assessment Scale
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego
San Diego, California, 92037, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward C Chao, DO
UCSD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 28, 2024
First Posted
May 3, 2024
Study Start
July 15, 2024
Primary Completion
August 1, 2024
Study Completion
September 1, 2024
Last Updated
July 17, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months after the study, up to 1 yr after.
- Access Criteria
- To be determined.
Considering sharing with other researchers.