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Completed

NCT Number: NCT05070949

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ramathibodi Hospital, Bangkok, Ratchatewi, Thailand

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Self-Compassion

Behavioral

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

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

  2. Hemoglobin A1C

    Time frame: baseline and 12 weeks

    HbA1c will be obtained by blood test.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Chulalongkorn University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2021
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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