NCT03484689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

March 17, 2018

Last Update Submit

January 31, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes-related distressMindfulness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Chinese Version of Diabetes Distress Scale (CDDS-15)

    At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16)

  • 9-item patient Health Questionnaire (PHQ-9)

    At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)

  • The Audit of Diabetes-Dependent Quality of Life (ADDQOL)

    At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)

Study Arms (1)

MBCT arm

OTHER

8-week MBCT program

Behavioral: Mindfulness-based cognitive therapy MBCT

Interventions

Mindfulness-based cognitive therapy MBCTBEHAVIORAL

8-week mindfulness-based cognitive therapy

MBCT arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pok Oi Hopsital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

March 17, 2018

First Posted

April 2, 2018

Study Start

July 14, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

HK(1)