MBCT for DM Distress: a Pilot Qusai-experimental Study
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy MBCT
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes-related distress, Mindfulness
Eligibility Criteria
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
Sites / Locations
- Pok Oi Hopsital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MBCT arm
Arm Description
8-week MBCT program
Outcomes
Primary Outcome Measures
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
Dropout rate
The proportion of patients attending at least 6 out of 8 classes
Secondary Outcome Measures
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.
9-item patient Health Questionnaire (PHQ-9)
A scale of depression score. Higher scores signifies more severe depression. Possible score ranged from 0-27
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.
Full Information
NCT ID
NCT03484689
First Posted
March 17, 2018
Last Updated
January 31, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03484689
Brief Title
MBCT for DM Distress: a Pilot Qusai-experimental Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 14, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes-related distress, Mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBCT arm
Arm Type
Other
Arm Description
8-week MBCT program
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy MBCT
Intervention Description
8-week mindfulness-based cognitive therapy
Primary Outcome Measure Information:
Title
Rate of recruitment
Description
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
Time Frame
From recruitment (1 April) till 20 patients are recruited (within 1 month)
Title
Dropout rate
Description
The proportion of patients attending at least 6 out of 8 classes
Time Frame
Week 1 (start of MBCT, intervention) till week 8
Secondary Outcome Measure Information:
Title
Chinese Version of Diabetes Distress Scale (CDDS-15)
Description
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.
Time Frame
At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16)
Title
9-item patient Health Questionnaire (PHQ-9)
Description
A scale of depression score. Higher scores signifies more severe depression. Possible score ranged from 0-27
Time Frame
At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)
Title
The Audit of Diabetes-Dependent Quality of Life (ADDQOL)
Description
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.
Time Frame
At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pok Oi Hopsital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will be available only if requested by other investigators.
Learn more about this trial
MBCT for DM Distress: a Pilot Qusai-experimental Study
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