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

Mahidol University34 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Mindful Self-CompassionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (2)

Faculty of Medicine Ramathibodi Hospital

Bangkok, Ratchatewi, Thailand

Faculty of Medicine Chulalongkorn University

Bangkok, Thailand

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: baseline to 24 weeks

Secondary Outcomes

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).

Time frame: baseline to 24 weeks

Hemoglobin A1C

HbA1c will be obtained by blood test.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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