A Guided Mobile-Based Perinatal Mindfulness Intervention

NCT04876014 | Unknown

• 1 other identifier: 17603520
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Mental Health Wellness 1

Keywords

Perinatal; Mindfulness; Intervention; Mobile-based; Randomized controlled trial

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• Psychological Well-being- Anxiety('change' is being assessed)

  Change from baseline Anxiety at post intervention (8 weeks), 36-week gestation and 5-week postpartum.

• Psychological Well-being- Affect('change' is being assessed)

  Change from baseline Affect at post intervention (8 weeks), 36-week gestation and 5-week postpartum.

• Psychological Well-being- Spirituality('change' is being assessed)

  Change from baseline Spirituality at post intervention (8 weeks), 36-week gestation and 5-week postpartum.

• Physical well-being-Stagnation('change' is being assessed)

  Change from baseline Stagnation at post intervention (8 weeks), 36-week gestation and 5-week postpartum.

Other Outcomes (4)

• Clinical outcomes-Obstetric outcomes

  5 weeks postpartum

• Clinical outcomes-Neonatal outcomes

  5 weeks postpartum

• Individual factors-Socio-demographic

  Baseline (Day 0)

Study Arms (2)

GMBPMI group

EXPERIMENTAL

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

Perinatal Psycho-education group

ACTIVE COMPARATOR

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

Interventions

Guided Mobile-Based Perinatal Mindfulness Intervention OTHER

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.

Also known as: GMBPMI

GMBPMI group; Perinatal Psycho-education group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

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  PMID: 21279709 RESULT

• Ng SM, Leng LL, Chan KP, Lo HH, Yeung A, Lu S, Wang A, Li HY. Study protocol of guided mobile-based perinatal mindfulness intervention (GMBPMI) - a randomized controlled trial. PLoS One. 2022 Jul 8;17(7):e0270683. doi: 10.1371/journal.pone.0270683. eCollection 2022.

  PMID: 35802637 DERIVED

Study Officials

• Siuman Ng, PhD

  HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: May 6, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available upon the completion of the research program and will be available for 5 years.
• Access Criteria: The IPD is considered to share upon formal request to the corresponding authors.

Locations

HK (1)