Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00382

2 Trial Registration Date

2013-12-04

i Registration Status

Prospective

3 Secondary IDs

HMRF 11120111

4 Source(s) of Funding

Health and Medical Research Fund, Food & Health Bureau, The Government of Hong Kong SAR

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Sally CHENG

ii Address

4/F, JC School of Public Health & Primary Care, Prince of Wales Hospital, Shatin

iii Phone

22528764

iv Email

sallycheng@cuhk.edu.hk

v Affiliation

JC School of Public Health & Primary Care, The Chinese University of Hong Kong

vi Country

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

i Name

Katrina TSANG

ii Address

4/F, JC School of Public Health & Primary Care, Prince of Wales Hospital, Shatin

iii Phone

22528462

iv Email

ktsang@cuhk.edu.hk

v Affiliation

JC School of Public Health & Primary Care, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Promoting Mental Well-being of Pregnant Women with Mindfulness-Based Childbirth and Parenting (MBCP): A Randomized Controlled Trial in Hong Kong

10 Public Title

Promoting Mental Well-being of Pregnant Women

i Public Title in Chinese 研究名稱

促進準父母心理健康計劃

11 Short Title (Optional)

MBCP RCT in HK

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?

2013-10-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pregnancy mental well-being

15 Intervention

i Types of intervention

Other

Please specify

Educational

ii Description/ name of Intervention/article

Mindfulness is a set of contemplative skills that cultivate non-judgemental moment-to-moment awareness, acceptance and non-avoidance of one’s present inner experience. Mindfulness is systematically taught over eight to ten weeks by group educational classes.

Mindfulness-based Childbirthing & Parenting (MBCP) is a nine-week antenatal programme with training in mindfulness through various activities such as mindful awareness of the breath, body, feelings, thoughts, and emotions; body scan meditation; mindful body movements; and loving-kindness meditation. Participants are invited to practice mindful activities at home for 30 to 45 minutes each day.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

The complete programme is 30 hours in total that includes 9 antenatal weekly sessions, a half-day re

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Active Control group – Antenatal Childbirth Education and Support (ACES).
This is an antenatal educational programme without the mindfulness components. The active control is a psycho-social placebo comparable to the intervention in terms of programme structure, instructor’s contact and attention, and class activities and homework assignments of similar nature and duration.

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) currently with a singleton pregnancy at 14–20 weeks of gestation (intervention starts at 20–25 weeks of gestation);
(2) being a resident of Hong Kong who will be living in Hong Kong for at least one year after childbirth;
(3) being able to communicate in Cantonese (group sessions will be conducted in Cantonese);
(4) being able to give informed consent;
(5) having no previous experience with meditation;
(6) having no daily practice with other mind–body techniques (e.g. yoga, tai-chi); and
(7) being willing and able to attend all the sessions.

ii Exclusion Criteria

(1) being a woman who does not meet all of the inclusion criteria;
(2) having a concurrent DSM-IV Axis diagnosis or recent diagnosis of depression during the last 12 months; and
(3) currently seeing a psychiatrist or mental health professional or receiving any form of treatment for any mental condition.

iii Age Minimum

18

iv Age Maximum

50

v Gender

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

2015-03-01

21 Target Sample Size

178

22 Recruitment Status

Recruiting

23 Primary Outcome

Self-reported Mental Component Scale (MCS-12)

This outcome is measured 4 times: before the intervention (T1), after the intervention (T2), at the reunion class at six to eight weeks (T3), and six months after childbirth (T4).

24 Secondary Outcome

1.SF-12; Chinese (HK specific)

2. Depression measured by the validated Hong Kong Chinese version of the Edinburgh Postnatal Depression Scale (EPDS).

3. Perceived Stress measured by the self-reported Hong Kong Chinese version 14-item Global Measure of Perceived Stress Scale (PSS-14)

4. Mindfulness level measured by the Hong Kong Chinese version self-reported 39-item Five Facets Mindfulness Questionnaire (FFMQ-C).

5. Center for Epidemiologic Studies Depression Scale_Eng (CES-D)

6.Multidimensional Assessment of Interceptive Awareness (MAIA)

7.Pain Catastrophizing Scale (PCS)

8.Prenatal Pregnancy Anxiety (PPA)

9.State-Trait Anxiety Inventory (STAI)

10.Pain Visual Analogue Scale

11.Satisfaction with Childbirth experience: Six Simple Questions (SSQ)

These outcomes are measured 4 times: before the intervention (T1), after the intervention (T2), at the reunion class at six to eight weeks (T3), and six months after childbirth (T4). Outcomes 9 (VAS) & 10 (SSQ) are measured shortly after childbirth.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13004070

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

www.sphpc.cuhk.edu.hk/pregnancyclass

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Trial History Detail on 2015-03-30