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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06398093
Other study ID # 810394
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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