A Guided Mobile-Based Perinatal Mindfulness Intervention

Psychological Distress Clinical Trial

Official title:

A Guided Mobile-Based Perinatal Mindfulness Intervention - A Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04876014
• Other study ID #: 17603520
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 198
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Health Wellness 1
• Psychological Distress

Intervention

Other:
• Guided Mobile-Based Perinatal Mindfulness Intervention
GMBPMI includes 6 EBMI lessons in 6 weeks, and it will require the participants to do mindfulness practice for about 30-60 minutes daily. The project RA will send prompt and guidance for daily mindfulness practice to each participant through social media platform. The RA will be available online to support, and will initiate chat every week throughout the whole intervention period. The chats will focus on participants' experiences or difficulties of mindfulness practice.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

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* Note: There are 60 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical outcomes-Obstetric outcomes	Obstetric outcomes includes a list of 6 questions collecting information about participant's gestational age at birth, pregnancy complications, mode of birth. They are fact data without scoring.	5 weeks postpartum
Other	Clinical outcomes-Neonatal outcomes	Neonatal outcomes includes a list of 4 questions collecting information about infant's birth weight, head circumference, months of maturity, and APGAR score.They are fact information without scoring.	5 weeks postpartum
Other	Individual factors-Socio-demographic	Socio-demographic includes age, gender, marital status, family income, employment, education, gestational age, parity, obstetric history, medical history, and pre-pregnancy BMI. No scoring system.	Baseline (Day 0)
Other	Individual factors-Social Support('change' is being assessed)	Social support is measured by Prenatal Social Support - 4 items. The minimum and maximum values range from 1 to 4, with higher score represents higher level of social support the participant has experienced.	Change from baseline Social Support at post intervention (8 weeks) and 36-week gestation.
Primary	Maternal psychological stress-General Stress ('change' is being assessed)	General stress will be measured by Perceived Stress Scale -10. The minimum and maximum values for each item is 1 to 4 with lower score represents lower stress.	Change from baseline General Stress at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Primary	Maternal psychological stress-Pregnancy specific stress('change' is being assessed)	Pregnancy specific stress will be measured by Prenatal Distress Questionnaire-12. The minimum and maximum values for each item is 0 to 4, with lower score represents lower stress.	Change from baseline Pregnancy specific stress at post intervention (8 weeks) and 36-week gestation.
Primary	Maternal psychological stress-Depression('change' is being assessed)	Depression is measured by Edinburgh Postnatal Depression Scale-Chinese-10. The minimum and maximum values are 1 to 4, with higher score represents higher depressive symptoms.	Change from baseline Depression at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Primary	Mindfulness-State mindfulness('change' is being assessed)	State mindfulness is measured bu Short-form Five Facet Mindfulness Questionnaire-Chinese-20 items. The minimum and maximum values are 0 to 4, with higher score represents higher state of mindfulness.	Change from baseline State MIndfulness at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Primary	Mindfulness-Daily mindfulness('change' is being assessed)	Daily mindfulness is measured by Daily Mindful Responding Scale - 4 items. The minimum and maximum values are 0 to 10, with higher score represents higher state of mindfulness.	Weekly changes from baseline Daily Mindfulness at 5-week postpartum.
Primary	Positive appraisal-Coping('change' is being assessed)	Coping is measured by Prenatal Coping Inventory - 22 items. The minimum and maximum values are 0 to 4, with higher score represents higher coping frequency.	Change from baseline Coping at post intervention (8 weeks) and 36-week gestation.
Primary	Heart rate variability('change' is being assessed)	HRV score, with higher score represents higher physical and mental condition for the day.	Change from baseline HRV at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Secondary	Psychological Well-being- Anxiety('change' is being assessed)	Anxiety is measured by Short-form State subscale of the State-Trait Anxiety Inventory - 6 items. The minimum and maximum values range from 0 to 4, with higher score represents higher anxiety level.	Change from baseline Anxiety at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Secondary	Psychological Well-being- Affect('change' is being assessed)	Affect is measured by Positive & Negative Affect Subscales of Body-Mind-Spirit Well-being Inventory 9 and 10 items. The minimum and maximum values range from 0 to 10, with higher score represents higher higher frequency of experiencing particular affect.	Change from baseline Affect at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Secondary	Psychological Well-being- Spirituality('change' is being assessed)	Spirituality is measured by Chinese Daily Spiritual Experience Sacle - 16 items. The minimum and maximum values range from 0 to 5, with higher score represents higher frequency of experiencing spirituality.	Change from baseline Spirituality at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Secondary	Physical well-being-Stagnation('change' is being assessed)	Stagnation is measured by Stagnation Scale - 16 items. The minimum and maximum values range from 0 to 10, with higher score represents higher stagnation level.	Change from baseline Stagnation at post intervention (8 weeks), 36-week gestation and 5-week postpartum.