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

Mahidol University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Mindful Self-Compassion

Study type: Interventional

Funder types: Other

Identifiers

NCT05070949

2933

Details and patient eligibility

About

This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Mindful Self-Compassion

Experimental group

Description:

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

Treatment:

Behavioral: Mindful Self-Compassion

Wait List Control

No Intervention group

Description:

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.