Psychological DistressNCT04876014
A Guided Mobile-Based Perinatal Mindfulness Intervention
A study testing Guided Mobile-Based Perinatal Mindfulness Intervention in people with Psychological Distress and Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Mental Health Wellness 1
- What is being tested?
- Guided Mobile-Based Perinatal Mindfulness Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult age 18 or above
- Pregnant Chinese women in their 2nd trimester
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Guided Mobile-Based Perinatal Mindfulness Intervention - A Randomized Control Trial
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.
Read the 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.
- Conditions
- Psychological Distress, Mental Health Wellness 1
- Being tested
- Guided Mobile-Based Perinatal Mindfulness Intervention
- Keywords
- Perinatal, Mindfulness, Intervention, Mobile-based, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Mobile-Based Perinatal Mindfulness InterventionOther
Also called GMBPMI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Guided Mobile-Based Perinatal Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Change from baseline Anxiety at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
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.
Measured: Change from baseline Affect at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
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.
Measured: Change from baseline Spirituality at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
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.
Measured: Change from baseline Stagnation at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Ng Siuman, The University of Hong Kong
- Investigators
- Siuman Ng, PhD, Principal investigator, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876014
- Sponsor's protocol ID
- 17603520
- Status last verified
- May 2021
- First submitted
- 30 Mar 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD is considered to share upon request.
Publications
Alder J, Fink N, Bitzer J, Hosli I, Holzgreve W. Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature. J Matern Fetal Neonatal Med. 2007 Mar;20(3):189-209. doi: 10.1080/14767050701209560.
PubMed 17437220Female age-related fertility decline. Committee Opinion No. 589. Obstet Gynecol. 2014 Mar;123(3):719-721. doi: 10.1097/01.AOG.0000444440.96486.61.
PubMed 24553169Alderdice F, Lynn F. Factor structure of the Prenatal Distress Questionnaire. Midwifery. 2011 Aug;27(4):553-9. doi: 10.1016/j.midw.2010.05.003. Epub 2010 Sep 15.
PubMed 20832921Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
PubMed 20967242Carlson LE, Speca M, Faris P, Patel KD. One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients. Brain Behav Immun. 2007 Nov;21(8):1038-49. doi: 10.1016/j.bbi.2007.04.002. Epub 2007 May 22.
PubMed 17521871Bonacquisti A, Cohen MJ, Schiller CE. Acceptance and commitment therapy for perinatal mood and anxiety disorders: development of an inpatient group intervention. Arch Womens Ment Health. 2017 Oct;20(5):645-654. doi: 10.1007/s00737-017-0735-8. Epub 2017 Jun 10.
PubMed 28600645Boyd, N. G., Lewin, J. E., & Sager, J. K. (2009). A model of stress and coping and their influence on individual and organizational outcomes. Journal of Vocational Behavior, 75(2), 197-211.
Braeken MA, Jones A, Otte RA, Nyklicek I, Van den Bergh BR. Potential benefits of mindfulness during pregnancy on maternal autonomic nervous system function and infant development. Psychophysiology. 2017 Feb;54(2):279-288. doi: 10.1111/psyp.12782. Epub 2016 Nov 7.
PubMed 28118687Byatt N, Biebel K, Friedman L, Debordes-Jackson G, Ziedonis D, Pbert L. Patient's views on depression care in obstetric settings: how do they compare to the views of perinatal health care professionals? Gen Hosp Psychiatry. 2013 Nov-Dec;35(6):598-604. doi: 10.1016/j.genhosppsych.2013.07.011. Epub 2013 Aug 19.
PubMed 23969144Chan KP. Prenatal meditation influences infant behaviors. Infant Behav Dev. 2014 Nov;37(4):556-61. doi: 10.1016/j.infbeh.2014.06.011. Epub 2014 Jul 24.
PubMed 25063985Chan, K. P. (2015). Effects of perinatal meditation on pregnant Chinese women in Hong Kong: a randomized controlled trial. Journal of Nursing Education and Practice, 5(1), 1.
Chan, K. P. (2016). Perceptions and experiences of pregnant Chinese women in Hong Kong on prenatal meditation: A qualitative study. Journal of Nursing Education and Practice, 6(3), 135.
Dewe, P., & Cooper, C. L. (2007). Coping research and measurement in the context of work related stress. International review of industrial and organizational psychology, 22, 141.
Carver CS, Connor-Smith J. Personality and coping. Annu Rev Psychol. 2010;61:679-704. doi: 10.1146/annurev.psych.093008.100352.
PubMed 19572784Collins NL, Dunkel-Schetter C, Lobel M, Scrimshaw SC. Social support in pregnancy: psychosocial correlates of birth outcomes and postpartum depression. J Pers Soc Psychol. 1993 Dec;65(6):1243-58. doi: 10.1037//0022-3514.65.6.1243.
PubMed 8295121
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Mobile-Based Perinatal Mindfulness Intervention - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04876014
- Acronym / sponsor ID
- 17603520
- Conditions
- Psychological Distress, Mental Health Wellness 1
- Keywords
- Perinatal, Mindfulness, Intervention, Mobile-based, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMBPMI group | Experimental | Other: Guided Mobile-Based Perinatal Mindfulness InterventionParticipants 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. |
| Perinatal Psycho-education group | Active comparator | Other: Guided Mobile-Based Perinatal Mindfulness InterventionTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult age 18 or above
- Pregnant Chinese women in their 2nd trimester
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Mobile-Based Perinatal Mindfulness InterventionAlso: GMBPMIGMBPMI 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 | GMBPMI group, Perinatal Psycho-education group |
Primary outcome
Maternal psychological stress-General Stress ('change' is being assessed)
Time frame: 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.
Maternal psychological stress-Pregnancy specific stress('change' is being assessed)
Time frame: 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.
Maternal psychological stress-Depression('change' is being assessed)
Time frame: 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.
Mindfulness-State mindfulness('change' is being assessed)
Time frame: 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.
Mindfulness-Daily mindfulness('change' is being assessed)
Time frame: 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.
Positive appraisal-Coping('change' is being assessed)
Time frame: 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.
Heart rate variability('change' is being assessed)
Time frame: 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.
4 secondary outcomes
Psychological Well-being- Anxiety('change' is being assessed)
Time frame: Change from baseline Anxiety at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Psychological Well-being- Affect('change' is being assessed)
Time frame: Change from baseline Affect at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Psychological Well-being- Spirituality('change' is being assessed)
Time frame: Change from baseline Spirituality at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Physical well-being-Stagnation('change' is being assessed)
Time frame: Change from baseline Stagnation at post intervention (8 weeks), 36-week gestation and 5-week postpartum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 17437220Alder J, Fink N, Bitzer J, Hosli I, Holzgreve W. Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature. J Matern Fetal Neonatal Med. 2007 Mar;20(3):189-209. doi: 10.1080/14767050701209560.
- Background: PubMed 24553169Female age-related fertility decline. Committee Opinion No. 589. Obstet Gynecol. 2014 Mar;123(3):719-721. doi: 10.1097/01.AOG.0000444440.96486.61.
- Background: PubMed 20832921Alderdice F, Lynn F. Factor structure of the Prenatal Distress Questionnaire. Midwifery. 2011 Aug;27(4):553-9. doi: 10.1016/j.midw.2010.05.003. Epub 2010 Sep 15.
- Background: PubMed 20967242Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
- Background: PubMed 17521871Carlson LE, Speca M, Faris P, Patel KD. One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients. Brain Behav Immun. 2007 Nov;21(8):1038-49. doi: 10.1016/j.bbi.2007.04.002. Epub 2007 May 22.
- Background: PubMed 28600645Bonacquisti A, Cohen MJ, Schiller CE. Acceptance and commitment therapy for perinatal mood and anxiety disorders: development of an inpatient group intervention. Arch Womens Ment Health. 2017 Oct;20(5):645-654. doi: 10.1007/s00737-017-0735-8. Epub 2017 Jun 10.
- BackgroundBoyd, N. G., Lewin, J. E., & Sager, J. K. (2009). A model of stress and coping and their influence on individual and organizational outcomes. Journal of Vocational Behavior, 75(2), 197-211.
- Background: PubMed 28118687Braeken MA, Jones A, Otte RA, Nyklicek I, Van den Bergh BR. Potential benefits of mindfulness during pregnancy on maternal autonomic nervous system function and infant development. Psychophysiology. 2017 Feb;54(2):279-288. doi: 10.1111/psyp.12782. Epub 2016 Nov 7.
- Background: PubMed 23969144Byatt N, Biebel K, Friedman L, Debordes-Jackson G, Ziedonis D, Pbert L. Patient's views on depression care in obstetric settings: how do they compare to the views of perinatal health care professionals? Gen Hosp Psychiatry. 2013 Nov-Dec;35(6):598-604. doi: 10.1016/j.genhosppsych.2013.07.011. Epub 2013 Aug 19.
- Background: PubMed 25063985Chan KP. Prenatal meditation influences infant behaviors. Infant Behav Dev. 2014 Nov;37(4):556-61. doi: 10.1016/j.infbeh.2014.06.011. Epub 2014 Jul 24.
- BackgroundChan, K. P. (2015). Effects of perinatal meditation on pregnant Chinese women in Hong Kong: a randomized controlled trial. Journal of Nursing Education and Practice, 5(1), 1.
- BackgroundChan, K. P. (2016). Perceptions and experiences of pregnant Chinese women in Hong Kong on prenatal meditation: A qualitative study. Journal of Nursing Education and Practice, 6(3), 135.
- Individual participant dataSharing planned: Yes. The IPD is considered to share upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siuman Ng, PhD principal investigator
HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Mobile-Based Perinatal Mindfulness Intervention in people with Psychological Distress and Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal psychological stress-General Stress ('change' is being assessed) (time frame: Change from baseline General Stress at post intervention (8 weeks), 36-week gestation and 5-week postpartum.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876014, which also lists 61 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.