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Trial History Detail on 2015-03-30

CUHK_CCT00382

2013-12-04

Prospective

HMRF 11120111

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

The Chinese University of Hong Kong

N/A

Sally CHENG

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

22528764

sallycheng@cuhk.edu.hk

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

Katrina TSANG

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

22528462

ktsang@cuhk.edu.hk

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

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

Promoting Mental Well-being of Pregnant Women

促進準父母心理健康計劃

MBCP RCT in HK

Hong Kong

Yes

2013-10-02

Pregnancy mental well-being

Other

Educational

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.

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

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.

(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.

(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.

18

50

Female

Interventional

Randomized

Active

Single-blind

Parallel

2015-03-01

178

Recruiting

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).

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.

No

2016-04-08

ChiCTR-TRC-13004070


Yes

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