MBCT for DM Distress: a Pilot Qusai-experimental Study

Study Overview
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Brief Summary
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Background: Diabetes-related distress (DRD) is very common among people with type II diabetes mellitus (DM). DRD led to poorer DM control and may led to adverse prognosis. Yet, there is no widely accepted or recommended DRD treatment. Mindfulness was shown to relieve psychological distress in various physical and mental conditions. Aim: as a pilot project, we aim to determine if mindfulness-based cognitive therapy (MBCT), which is one of the widely used mindfulness program, is feasible and acceptable and may improve DRD in our Chinese population. Method: 20 Chinese participants with suboptimally controlled DM and high DRD will be recruited to a 8- week MBCT group. Pre-group and post-group (immediate and 2-month post-group) data including DRD score, quality-of life measures will be compared.

Official Title
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Mindfulness-based Cognitive Therapy (MBCT) for Type II Diabetes Mellitus (DM) Patients With High Diabetes Distress and Suboptimal DM Control: a Pilot Qusai-experimental Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Mindfulness-based cognitive therapy MBCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: received a clinical diagnosis of type II DM aged >=18 can provide valid consent can speak Cantonese can read and write simple Chinese HbA1c >7% have CDDS score >=3 Exclusion Criteria: diagnosed active mental illness have severe hearing loss non-Chinese have active suicidal ideation as screened by Q9 of PHQ-9 unwilling to join at least 6 out of 8 session of MBCT received mindfulness training in the past year or having regular mindfulness practice received psychotherapy last year severe physical illness limiting them from coming repeatedly to the group

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MBCT arm<br>8-week MBCT program | Behavioral: Mindfulness-based cognitive therapy MBCT<br>* 8-week mindfulness-based cognitive therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recruitment | As a pilot study, we like to determine if it is feasible to recruit the target patients and measure the relevant outcomes. The number of patient approached and the number of patient recruited will be recorded | From recruitment (1 April) till 20 patients are recruited (within 1 month) | 
| Dropout rate | The proportion of patients attending at least 6 out of 8 classes | Week 1 (start of MBCT, intervention) till week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese Version of Diabetes Distress Scale (CDDS-15) | A scale to diagnose and monitor Diabetes Related Distress. The scale ranged from score 0 to 6. The higher the score, the higher the distress. | At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16) | 
| 9-item patient Health Questionnaire (PHQ-9) | A scale of depression score. Higher scores signifies more severe depression. Possible score ranged from 0-27 | At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16) | 
| The Audit of Diabetes-Dependent Quality of Life (ADDQOL) | A measure of Diabetes specific quality of life. The possible score for each domain is from -9(most negative impact of diabetes) to +3 (most positive impact of diabetes). Domains include leisure work, journey, holiday, physical, family life, friendships and social life, personal relationship, sex life, physical appearance, self-confidence, motivation, reactions of other people, feelings about future, financial situation, living conditions, depend on others, freedom to eat, and freedom to drink. The total score is the weighted average of all the domain, so the total score also ranged from -9 to +3. | At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes-related distress, Mindfulness