MBCT for DM Distress: a Pilot Qusai-experimental Study
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Mindfulness-based cognitive therapy MBCT
- Registration Number
- NCT03484689
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MBCT arm Mindfulness-based cognitive therapy MBCT 8-week MBCT program
- Primary Outcome Measures
Name Time Method Rate of recruitment From recruitment (1 April) till 20 patients are recruited (within 1 month) 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
Dropout rate Week 1 (start of MBCT, intervention) till week 8 The proportion of patients attending at least 6 out of 8 classes
- Secondary Outcome Measures
Name Time Method Chinese Version of Diabetes Distress Scale (CDDS-15) At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16) 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.
The Audit of Diabetes-Dependent Quality of Life (ADDQOL) At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16) 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.
9-item patient Health Questionnaire (PHQ-9) At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16) A scale of depression score. Higher scores signifies more severe depression. Possible score ranged from 0-27
Trial Locations
- Locations (1)
Pok Oi Hopsital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong