Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes

May 8, 2025 updated by: Ratanaporn Jerawatana, Mahidol University
This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study tests the effects of a 12-week mindful self-compassion (MSC) program in people with type 1 diabetes. Eighty participants will be randomized to the MSC program or be in a wait-list control group. Measures of primary outcome are self-compassion and diabetes- distress. Secondary outcomes are hemoglobin A1C, diabetes self-efficacy, stress and depression symptoms, and sleep quality. Outcomes will be measured at baseline, 12 weeks (end of the program) and 24 weeks (post program).

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine Chulalongkorn University
    • Ratchatewi
      • Bangkok, Ratchatewi, Thailand, 10400
        • Faculty of Medicine Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • type 1 diabetes, age 18-30
  • own computer or tablet with access to internet for meetings
  • willingness to complete all 6 sessions

Exclusion criteria:

  • history of self-harm or suicide attempt in the pat one year
  • severe diabetic complications such as dialysis or blindness
  • unstable depression, requiring ongoing medication adjustment within the last 3 months
  • A1C > 11%
  • Severe hypoglycemia requiring emergency room visit or hospitalization in the past 6 months
  • History of Diabetic Ketoacidosis requiring hospitalization in the past 3 months
  • pregnant or intend to get pregnant during the study timeframe

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindful Self-Compassion
Participants will meet every 2 weeks via zoom application or equivalent online meeting platforms, for 12 weeks. The sessions will be led by a clinical psychologist. The curriculum will follow mindful compassion program by Neff KD
Behavioral: Mindful Self-Compassion
Bi-weekly meeting will involve six lessons: What is Self-Compassion , Practicing Self-Compassion, Discovering your Compassionate Voice, Self-Compassion and Resilience , Self-Compassion and Burnout and Making it Count
No Intervention: Wait List Control
Wait list control group will not participate in the MSC program during the first 12 weeks of the protocol but will be given an opportunity to participate after 12 weeks, using the same curriculum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes distress
Time Frame: baseline to 24 weeks

Diabetes distress will be evaluated by a questionnaire. Each item is rated on a 6-point Likert scale from 1 (no problem) to 6 (serious problems).

Scores range from 17 to 102, which the higher scores indicate the higher diabetes distress levels (A worse outcome).
baseline to 24 weeks
Self-compassion
Time Frame: baseline to 24 weeks

Self-compassion will be evaluated by a questionnaire. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).

Scores range from 26 to 130, which the higher scores indicate the higher self-compassion levels (A better outcome). This outcome is reported in the mean difference of self-compassion score between two groups.
baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Self-efficacy
Time Frame: baseline to 24 weeks

Diabetes self-efficacy will be measured by questionnaire. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).

Scores range from 19 to 95, which the higher scores indicate the higher self-efficacy levels (A better outcome).
baseline to 24 weeks
Hemoglobin A1C
Time Frame: baseline and 12 weeks
HbA1c will be obtained by blood test.
baseline and 12 weeks
Sleep quality
Time Frame: baseline to 24 weeks

Sleep quality will be measured by a questionnaire. Each item is rated on a 4-point Likert scale from 0 (very good) to 3 (very bad).

Scores range from 0 to 21, which the higher scores indicate poor sleep quality (A worse outcome).
baseline to 24 weeks
Stress and depressive symptoms
Time Frame: baseline to 24 weeks
stress and depressive symptoms will be measured by a questionnaire. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). Scores range from 0 to 40, which the higher scores indicate higher stress and depression (A worse outcome). This outcome is reported in the mean difference of stress and depression score between two groups.
baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

May 15, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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