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A Guided Mobile-Based Perinatal Mindfulness Intervention

Sponsor
The University of Hong Kong (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04876014
Collaborator
(none)
198
Enrollment
1
Location
2
Arms
29.9
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Guided Mobile-Based Perinatal Mindfulness Intervention
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Guided Mobile-Based Perinatal Mindfulness Intervention - A Randomized Control Trial
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GMBPMI group

Participants in the experimental group will receive GMBPMI. A new participant (a pregnant woman in the second trimester) is expected to complete the 6 EBMI lessons in 6 weeks, and do the 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. Participants will also be asked to keep log of daily mindfulness practice from T0 to T3 using Google Form. The project 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. The RA is backed up by the PI and co-I's who are experienced mental health practitioner and mindfulness teacher. One of them is an obstetrics and gynaecology specialist.

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.
Other Names:
  • GMBPMI

    		•
    Active Comparator: Perinatal Psycho-education group

    To control for attention and placebo effects, every new participant in the control group will receive weekly web-based psychoeducation program for perinatal care. The project RA will also be available online to support, and will initiate chat every week throughout the whole intervention period. The chats will focus on participants' experiences of the psychoeducation program.

    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.
    Other Names:
  • GMBPMI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maternal psychological stress-General Stress ('change' is being assessed) [Change from baseline General Stress at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    2. Maternal psychological stress-Pregnancy specific stress('change' is being assessed) [Change from baseline Pregnancy specific stress at post intervention (8 weeks) and 36-week gestation.]

      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.

    3. Maternal psychological stress-Depression('change' is being assessed) [Change from baseline Depression at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    4. Mindfulness-State mindfulness('change' is being assessed) [Change from baseline State MIndfulness at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    5. Mindfulness-Daily mindfulness('change' is being assessed) [Weekly changes from baseline Daily Mindfulness at 5-week postpartum.]

      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.

    6. Positive appraisal-Coping('change' is being assessed) [Change from baseline Coping at post intervention (8 weeks) and 36-week gestation.]

      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.

    7. Heart rate variability('change' is being assessed) [Change from baseline HRV at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      HRV score, with higher score represents higher physical and mental condition for the day.

    Secondary Outcome Measures

    1. Psychological Well-being- Anxiety('change' is being assessed) [Change from baseline Anxiety at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    2. Psychological Well-being- Affect('change' is being assessed) [Change from baseline Affect at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    3. Psychological Well-being- Spirituality('change' is being assessed) [Change from baseline Spirituality at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    4. Physical well-being-Stagnation('change' is being assessed) [Change from baseline Stagnation at post intervention (8 weeks), 36-week gestation and 5-week postpartum.]

      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.

    Other Outcome Measures

    1. Clinical outcomes-Obstetric outcomes [5 weeks postpartum]

      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.

    2. Clinical outcomes-Neonatal outcomes [5 weeks postpartum]

      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.

    3. Individual factors-Socio-demographic [Baseline (Day 0)]

      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.

    4. Individual factors-Social Support('change' is being assessed) [Change from baseline Social Support at post intervention (8 weeks) and 36-week gestation.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Hong Kong Hong Kong Hong Kong

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    • Principal Investigator: Siuman Ng, PhD, HKU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof. Ng Siuman, Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04876014
    Other Study ID Numbers:
    • 17603520
    First Posted:
    May 6, 2021
    Last Update Posted:
    May 10, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Ng Siuman, Professor, The University of Hong Kong
    Perinatal
    Mindfulness
    Intervention
    Mobile-based
    Randomized controlled trial

    Study Results

    No Results Posted as of May 10, 2021