MBCT for DM Distress: a Pilot Qusai-experimental Study

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Mindfulness-based cognitive therapy MBCT

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Pok Oi Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MBCT arm; 8-week MBCT program	Behavioral: Mindfulness-based cognitive therapy MBCT; 8-week mindfulness-based cognitive therapy

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: March 17, 2018
• First Submitted That Met QC Criteria: March 25, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Mindfulness; Diabetes-related distress
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CREC17123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Will be available only if requested by other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No