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
Not Applicable
April Luo
4/F, JC School of Public Health & Primary Care, Prince of Wales Hospital, Shatin
22528768
aprilluo@cuh.edu.hk
JC School of Public Health & Primary Care, The Chinese University of Hong Kong
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
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
Joint CUHK-NTEC Clinical Research Ethics Committee
CRE-2013.463-T
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.
N/A
N/A
The complete programme is 30 hours in total that includes 9 antenatal weekly sessions, a half-day re
Weekly for 10 sessions
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.
N/A
N/A
N/A
Same as intervention
(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
Stratified
Active
Single-blind
Trial subjects
Parallel
Other
N/A
2015-03-01
178
Complete
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.
2016-04-08
ChiCTR-TRC-13004070
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