Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00265

2 Trial Registration Date

2010-05-25

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Research fund for the control of infectious diseases/ Health and health services research fund

5 Primary Sponsor

Prof. Samuel Yeung Shan WONG

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Rebecca Hou Jing

ii Address

Room 429, School of Pubic Health and Primary Care

iii Phone

22528794

iv Email

rebeccajh@cuhk.edu.hk

v Affiliation

PHD candidate

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Samuel Yeung Shan WONG

ii Address

Room 408, School of Pubic Health and Primary Care

iii Phone

Nil

iv Email

yeungshanwong@cuhk.edu.hk

v Affiliation

Professor

vi Country

9 Official Scientific Title of the Study

The effect of a mindfulness based stress reduction programme on immune status in caregivers with chronic psychosocial stress in Hong Kong: a randomized controlled trial

10 Public Title

The effect of a mindfulness based stress reduction programme on immune status in caregivers with chronic psychosocial stress in Hong Kong: a randomized controlled trial

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-02-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

caregivers with chronic psychosocial stress

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

mindfulness based stress reduction

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

8 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

multidiscipline support for caregivers

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. a first-degree family member with chronic diseases
2. score on Caregiver Strain Index of 7 or more
3. the primary care givers
4. provide care for patient at home
5. report no other caregiving responsibilities
6. informed consent available
7. agree to receive influenza vaccine

ii Exclusion Criteria

1. Individuals suffering from untreated chronic disease, autoimmune disease, cancer, and any other disease known to alter immunity or those receiving corticosteroids or immunosuppressive therapy or cytotoxic therapy
2. past participation in an MRSR group
3. current or prior practice of meditation or relaxation technique including MBSR

iii Age Minimum

18

iv Age Maximum

nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-06-07

21 Target Sample Size

140

22 Recruitment Status

Unknown

23 Primary Outcome

Influenza-specific antibody response
Perceived Stress

24 Secondary Outcome

Caregiver Strain
Depression
Anxiety
Quality of life
Mindfulness

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-10-22

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10000904

28 Date of Registration in Primary Registry

2010-10-15

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-10-22