MBCT for DM Distress: a Pilot Qusai-experimental Study

NCT ID: NCT03484689

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-14

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBCT arm

8-week MBCT program

Group Type OTHER

Mindfulness-based cognitive therapy MBCT

Intervention Type BEHAVIORAL

8-week mindfulness-based cognitive therapy

Interventions

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Mindfulness-based cognitive therapy MBCT

8-week mindfulness-based cognitive therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lee Kam Pui

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pok Oi Hopsital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CREC17123

Identifier Type: -

Identifier Source: org_study_id

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