MBCT for DM Distress: a Pilot Qusai-experimental Study

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484689
• Other study ID #: CREC17123
• Status: Completed
• Phase: N/A
• Start date: July 14, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Mindfulness-based cognitive therapy MBCT
8-week mindfulness-based cognitive therapy

Locations

Country	Name	City	State
Hong Kong	Pok Oi Hopsital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Dropout rate	The proportion of patients attending at least 6 out of 8 classes	Week 1 (start of MBCT, intervention) till week 8
Secondary	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)
Secondary	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)
Secondary	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)