Diabetes Mellitus, Type 2NCT03484689
MBCT for DM Distress: a Pilot Qusai-experimental Study
A study testing Mindfulness-based cognitive therapy MBCT in people with Diabetes Mellitus, Type 2, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mindfulness-based cognitive therapy MBCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jul 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mindfulness-based cognitive therapy MBCT
- Keywords
- Diabetes-related distress, Mindfulness
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive therapy MBCTBehavioural
8-week mindfulness-based cognitive therapy
| Study group | Role | What they receive |
|---|---|---|
| MBCT arm | Other | 8-week MBCT program Receives: Behavioral: Mindfulness-based cognitive therapy MBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 1 (start of MBCT, intervention) till week 8
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start14 Jul 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484689
- Sponsor's protocol ID
- CREC17123
- Status last verified
- Jan 2019
- First submitted
- 17 Mar 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be available only if requested by other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03484689
- Acronym / sponsor ID
- CREC17123
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes-related distress, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCT arm | Other | Behavioral: Mindfulness-based cognitive therapy MBCT8-week MBCT program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- received a clinical diagnosis of type II DM
- aged >=18
- can provide valid consent
- can speak Cantonese
- can read and write simple Chinese
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based cognitive therapy MBCT8-week mindfulness-based cognitive therapy | Behavioural | MBCT arm |
Primary outcome
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
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
3 secondary outcomes
Chinese Version of Diabetes Distress Scale (CDDS-15)
Time frame: At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16)
9-item patient Health Questionnaire (PHQ-9)
Time frame: At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Undecided. Will be available only if requested by other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive therapy MBCT in people with Diabetes Mellitus, Type 2, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: From recruitment (1 April) till 20 patients are recruited (within 1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.