Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Behavioral: Mindful Self-Compassion
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindful Self-Compassion 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
- 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