Clinical trial NCT05070949: Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes
Official title: Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: self-compassion
diabetes distress
sleep
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
First posted: 2021-10-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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
* pregnant or intend to get pregnant during the study timeframe

Primary outcomes:
measure: Diabetes distress
timeFrame: baseline to 24 weeks
measure: Self-compassion
timeFrame: baseline to 24 weeks
Secondary outcomes:
measure: Diabetes Self-efficacy
timeFrame: baseline to 24 weeks
measure: Hemoglobin A1C
timeFrame: baseline and 12 weeks
measure: Sleep quality
timeFrame: baseline to 24 weeks
measure: Stress and depressive symptoms
timeFrame: baseline to 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital
state: Ratchatewi
city: Bangkok
country: Thailand
facility: Faculty of Medicine Chulalongkorn University
Study officials:
References:
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