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

Not Applicable

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT05070949
• Lead Sponsor: Mahidol University

Brief Summary

This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.

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 Timeline

• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-07
• Study Start: 2022-01-01
• Primary Completion: 2023-10-10
• Study Completion: 2023-11-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetes distress	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).
Self-compassion	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.

Secondary Outcome Measures

Name	Time	Method
Stress and depressive symptoms	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.
Diabetes Self-efficacy	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).
Hemoglobin A1C	baseline and 12 weeks	HbA1c will be obtained by blood test.
Sleep quality	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).

Trial Locations

Locations (2)

Faculty of Medicine Ramathibodi Hospital; 🇹🇭 Bangkok, Ratchatewi, Thailand

Faculty of Medicine Chulalongkorn University; 🇹🇭 Bangkok, Thailand