Clinical trial NCT04876014: A Guided Mobile-Based Perinatal Mindfulness Intervention
Official title: A Guided Mobile-Based Perinatal Mindfulness Intervention - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Distress
Mental Health Wellness 1
Keywords: Perinatal
Mindfulness
Intervention
Mobile-based
Randomized controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychological distress commonly occurs among women during perinatal period. maternal psychological distress can also bring negative influence on neonatal outcomes, such as infant health, child development or mother-child interaction. Hence, developing interventions to improve mental wellbeing during this period is vital. Mindfulness based intervention (MBI) was found effective in reducing psychological distress. Most currently, delivering MBIs via internet, which is more accessible and inexpensive, shows promising positive effect in reducing psychological distress. However, randomized control trial with sufficient power is await to further confirm the positive effect among pregnant women. Moreover, the positive effects of MBIs was found associated with the heart rate variability biofeedback. However, the efficacy of MBI on HRV is rarely studied among pregnant women. Also, the potential association of HRV between MBI and psychological wellbeing needs further examination. This research aims to test the effectiveness of the Guided-Mobile Based Perinatal Mindfulness Intervention (GMBPMI) among pregnant women experiencing psychological distress during the pre and post-natal period, as well as examining the efficacy of GMBPMI on HRV.

Detailed description: BACKGROUND Being pregnant, giving birth and turning into a mother are three closely intertwined major life transitions that a woman would experience within a short period of time. This period is often clouded by intense distress due to dramatic physical and psychosocial changes. In Hong Kong, a highly competitive and work-intense society, women face pressures on all fronts. Hong Kong ranks among the fifth with the oldest first-time mother in the world. Pregnancy at an older age is a known risk factor for antenatal depression. Women's labor force participation rate in Hong Kong is high - 84.1% in the 20-39 age group. The difficulty of balancing work and life is amplified when a woman is pregnant.

The adverse consequences of stress are broad and far-reaching, shaping obstetric and neonatal outcomes, including increased analgesic use and unplanned cesarean delivery, preterm delivery, low birth weight and Apgar scores, smaller head circumference and major congenital anomalies. Research started to reveal that the disrupting maternal cardiovascular system in pregnant women with elevated psychological distress, indexed by low heart rate variability (HRV), might be a mechanism for the worsening of birth outcomes. However, the finding is not conclusive.

In the recent decade, empirical research supporting the efficacy of prenatal mindfulness-based interventions (MBI) has emerged. MBI cultivates abilities that are important to pregnant women and new mothers, such as savoring, self-acceptance and psychological flexibility. In Hong Kong, the investigators developed and evaluated a cultural-sensitive MBI - Eastern-Based Meditation Intervention (EBMI) for pregnant women. The intervention not only showed significantly positive effects on prenatal distress coping and salivary cortisol reduction, but also associated with positive infant outcomes, including a higher cord blood cortisol level at birth and a less difficult temperament. Higher cord blood cortisol levels are believed to protect against the development of neonatal health abnormalities.

While the efficacy of prenatal MBI has been revealed in the past decade, the availability and usage of the programme remain low for various practical reasons. Moreover, providing only a limited number of lessons, mostly in the second trimester, seems insufficient. It is highly desirable to provide extended support so as to ensure continued mindfulness practice in both pre and postnatal period.

Considering the predicaments of pregnant woman/new mother, a guided mobile-based MBI appears to be more feasible than the traditional face-to-face mode. Grounded on EBMI, the investigators developed and satisfactorily piloted a guided mobile-based perinatal mindfulness intervention (GMBPMI).

OBJECTIVE and DESIGN The project aims to rigorously evaluate GMBPMI. The research adopts a parallel-armed, randomized controlled trial design. To control for confounding effects, such as attention and placebo effect, the trial will utilize an active control group. Participants in the control group will receive psychoeducation on perinatal care mimic the schedule and level of support of the experimental group.The target sample size is 198.

Pregnant women in the second trimester will be recruited to the program. With the support of a trained research assistant (RA), participants can take the 6 weekly EBMI lessons online flexibly at home. The RA will provide continued prompt and support for mindfulness practice to each participant till 5 weeks postpartum. The RA is backed up by the PI and co-I's who are experienced mental health practitioners and mindfulness teachers. One of them is an experienced obstetrics and gynaecology specialist.

EXPECTED OUTCOME In Hong Kong, around 50,000 newborn babies are delivered each year. To meet the service needs of this scale, it is imperative for us to develop a cost-effective, accessible and acceptable intervention, tailored to the predicaments of women during the perinatal period. To address the barrier and cost issues, a guided mobile-based perinatal mindfulness intervention appears to be a good choice. If the model is shown to be effective, it can be a practical solution to a large scale mental health issue - benefiting women significantly during pregnancy, as well as enhancing the subsequent mental health outcomes of these women and the well-being of their babies.

Eligibility criteria: Inclusion Criteria:

* Adult age 18 or above
* Pregnant Chinese women in their 2nd trimester

Exclusion Criteria:

* Not able to understand Chinese (the intervention will be delivered in Chinese)
* High-risk pregnancy status (e.g., preterm labor, placental abnormality, multiple gestations, required bed rest, or morbid obesity)
* Current psychiatric disorders that necessitated priority attention (e.g., schizoaffective disorder, bipolar disorder, or current psychosis; organic mental disorder or pervasive developmental delay; current substance abuse or dependence; imminent suicide or homicide risk)

Primary outcomes:
measure: Maternal psychological stress-General Stress ('change' is being assessed)
timeFrame: Change from baseline General Stress at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
measure: Maternal psychological stress-Pregnancy specific stress('change' is being assessed)
timeFrame: Change from baseline Pregnancy specific stress at post intervention (8 weeks) and 36-week gestation.
measure: Maternal psychological stress-Depression('change' is being assessed)
timeFrame: Change from baseline Depression at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
measure: Mindfulness-State mindfulness('change' is being assessed)
timeFrame: Change from baseline State MIndfulness at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
measure: Mindfulness-Daily mindfulness('change' is being assessed)
timeFrame: Weekly changes from baseline Daily Mindfulness at 5-week postpartum.
measure: Positive appraisal-Coping('change' is being assessed)
timeFrame: Change from baseline Coping at post intervention (8 weeks) and 36-week gestation.
measure: Heart rate variability('change' is being assessed)
timeFrame: Change from baseline HRV at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Secondary outcomes:
measure: Psychological Well-being- Anxiety('change' is being assessed)
timeFrame: Change from baseline Anxiety at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
measure: Psychological Well-being- Affect('change' is being assessed)
timeFrame: Change from baseline Affect at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
measure: Psychological Well-being- Spirituality('change' is being assessed)
timeFrame: Change from baseline Spirituality at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
measure: Physical well-being-Stagnation('change' is being assessed)
timeFrame: Change from baseline Stagnation at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Other outcomes:
measure: Clinical outcomes-Obstetric outcomes
timeFrame: 5 weeks postpartum
measure: Clinical outcomes-Neonatal outcomes
timeFrame: 5 weeks postpartum
measure: Individual factors-Socio-demographic
timeFrame: Baseline (Day 0)
measure: Individual factors-Social Support('change' is being assessed)
timeFrame: Change from baseline Social Support at post intervention (8 weeks) and 36-week gestation.
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: HKU
name: Siuman Ng, PhD
role: PRINCIPAL_INVESTIGATOR
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