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Completed

NCT Number: NCT03484689

MBCT for DM Distress: 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pok Oi Hopsital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based cognitive therapy MBCT

Behavioral

8-week mindfulness-based cognitive therapy

Primary outcomes

  1. Rate of recruitment

    Time frame: From recruitment (1 April) till 20 patients are recruited (within 1 month)

    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

  2. Dropout rate

    Time frame: Week 1 (start of MBCT, intervention) till week 8

    The proportion of patients attending at least 6 out of 8 classes

Secondary outcomes

  1. Chinese Version of Diabetes Distress Scale (CDDS-15)

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

    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.

  2. 9-item patient Health Questionnaire (PHQ-9)

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

    A scale of depression score. Higher scores signifies more severe depression. Possible score ranged from 0-27

  3. The Audit of Diabetes-Dependent Quality of Life (ADDQOL)

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

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2018
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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