Type 1 Diabetes
Conditions
Keywords
self-compassion, diabetes distress, sleep
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).
Interventions
BEHAVIORALMindful Self-Compassion
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
Sponsors
Chulalongkorn University
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
Thailand
Outcome results
None listed