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Clinical Trials/NCT05070949
NCT05070949
Completed
Not Applicable

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

Mahidol University2 sites in 1 country34 target enrollmentJanuary 1, 2022
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Mahidol University
Enrollment
34
Locations
2
Primary Endpoint
Diabetes distress
Status
Completed
Last Updated
11 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
November 7, 2023
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ratanaporn Jerawatana

Principal Investigator

Mahidol University

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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).

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

  • Stress and depressive symptoms(baseline to 24 weeks)
  • Diabetes Self-efficacy(baseline to 24 weeks)
  • Hemoglobin A1C(baseline and 12 weeks)
  • Sleep quality(baseline to 24 weeks)

Study Sites (2)

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