Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Package of Community-based Mental Healthcare Services in Preventing Perinatal Mental Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678415
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

During pregnancy and in the year after birth women can be affected by a range of mental health problems. Anxiety and depression are the most prevalent mental illnesses during the perinatal period. In low socio-economic country like Bangladesh, there is a huge knowledge gap. Perinatal mental disorders are preventable or manageable conditions if can be addresses primariliry at the community level. Better antenatal detection of depression offers an opportunity for earlier intervention to address the illness and reduce the risk that will cause longer term problems for the mother or her baby. Most of the patients do not seek care for mental health problems as they think if they go for treatment other people would tell them 'mad'. Moreover, due to lack of necessary training of the healthcare providers at primary and secondary level the patients with mental health problems cannot get adequate services to meet the requirements. Objective of the study is to develop a package of community-based primary mental healthcare services for delivering with the maternal services care in preventing perinatal mental disorders.

The investigators will conduct an interventional study by using both quantitative and qualitative research methodology. At first, a literally feasible package of community-based primary mental healthcare services will be developed through series of workshops. Then training will be provided to the community health workers on developed package. For the cluster randomization trial will be done to test the efficacy in reduction of perinatal mental disorders. One group of pregnant mothers will be provided the developed package of sevices along with the antenatal care and another group will be provided only routine antenatl care. Both the groups will be ensured at least four sessions of antenatal care. Following up will be through the whole pregnancy period. Afterthat, assessment will be done on mental disorders (anxiety and depression) among the both groups and will be compared to find the efficacy of the package in terms of proportion of mental disorders among the perinatal mothers. For data collection, we use different check list. Moreover, in-depth interview and focus group discussion with different groups of community people will be done to get feedback and suggestions on the package. Then the community based primary mental healthcare package will be finalized.


Condition or disease Intervention/treatment Phase
Mental Disorder Behavioral: Community-Based Primary Mental Health Care (CBPMHC) package Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community Based Maternal Healthcare Services
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control
In the control arm, the community healthcare providers serve usual health education like counseling as they provided in perinatal period of enrolled mothers regular follow up basis. This health education is different from developed intervention. But service provider does not know. The investigators select community clinic before provide training regarding training manual. For this, the investigators selected 11 cluster randomly among the 23 community clinics' in the primary health care in study area and provide common health education instructions to the enrolled mothers. But service providers does not know the intervention package services that will provide in intervention arm's service providers.
Behavioral: Community-Based Primary Mental Health Care (CBPMHC) package
According to the intervention package, after receiving training, the service providers will start providing service according to learning to the enrolled mothers. The intervention package has developed in many maternal and psychosocial supports like psycho-educational communication about pregnancy complications, danger signs, birth preparedness; psycho-social support including information about psycho-education, graded activities and different types of alternative thoughts. Besides, in this regard the investigators included anxiety and depression disorders symptoms, postpartum mood disorders like postpartum blue, postpartum psychosis, etc. The primary healthcare service provider's provide intervention along with their daily routine and investigators follow it up by their visits.




Primary Outcome Measures :
  1. Number of study participants with depression, anxiety and stress in perinatal period [ Time Frame: 18 months ]
    Investigators assume developed intervention helps to prevent mental health disorders


Secondary Outcome Measures :
  1. Number of live births among the study participant's fetus [ Time Frame: 18 months ]
    Developed intervention helps to increase live births among the study participant's fetus

  2. Number of still births among the study participant's fetus [ Time Frame: 18 months ]
    Developed intervention helps to decrease still births among the study participant's fetus

  3. Number of low birth weight babies among the study participant's fetus [ Time Frame: 18 months ]
    Developed intervention helps to decrease still births among the study participant's fetus



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Permanent resident of the study area
  • Pregnant women aged >18 years
  • Upon taking informed consent

Exclusion Criteria:

  • Temporary resident of the study areas
  • Severely ill patients (documented by registered physician with prescription)
  • Refusal to take part in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678415


Locations
Layout table for location information
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Additional Information:
Publications of Results:
Oates M. Perinatal maternal mental health services. Recommendations for provision of services for childbearing women. London: Royal College of Psychiatrists. 2001
O'Hara MW, Swain AM. Rates and risk of postpartum depression - a meta-analysis. Int Rev Psychiatry, 1996; 8:37-54
Ramchandani PG, Stein A, Evans J, O'Connor TG. Paternal depression in the postnatal period and child development: a prospective population study. Obstetrical & gynaecological survey, 2005;60(12), 789-790
Edge D. Perinatal Mental Health of Black and Minority Ethnic Women: A Review of Current Provision in England, Scotland and Wales. National Mental Health Development Unit. 2011.
Center on the Developing Child at Harvard University. Maternal Depression Can Undermine the Development of Young Children: 2009; Working Paper No. 8
World Health organization. Health in 2015: from MDGs, Millennium Development Goals to SDGs, Sustainable Development Goals. WHO 2015
Nasreen HE, Edhborg M, Petzold M, Forsell Y, Kabir ZN (2015) Incidence and Risk Factor of Postpartum Depressive Symptoms in Women: A Population Based Prospective Cohort Study in a Rural District in Bangladesh. J Depress Anxiety 4 (2): 1000180

Layout table for additonal information
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03678415    
Other Study ID Numbers: PR-17042
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Depression, anxiety and stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders