Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398093
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-28
Brief Title:
Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None