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

Study Overview
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Brief Summary
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This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.

Detailed Description
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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).

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Mindful Self-Compassion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Self-Compassion<br>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<br>* 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<br>|
| No Intervention: Wait List Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes distress | 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 | 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 | 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 | HbA1c will be obtained by blood test. | baseline and 12 weeks | 
| Sleep quality | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-compassion, diabetes distress, sleep