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Clinical Trials/NCT03678415
NCT03678415CompletedNot Applicable

Community Based Maternal Healthcare Services

International Centre for Diarrhoeal Disease Research, Bangladesh2 sites in 1 country1,210 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,210
Locations
2
Primary Endpoint
Number of study participants with depression, anxiety and stress in perinatal period

Study Overview

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.

Detailed Description

Globally mental health conditions are of rising concern due to increased contribution to the global burden of disease. Mental health wellbeing cannot be determined by only the absence of mental disorders but also determined by related socio-economic, biological and environmental factors. Mental health disorders refer to a set of medical conditions that affect a person's thinking, feeling, mood, ability to relate to others, and daily functioning. According to the World Health Organization mental disorders comprise a broad range of problems, with different symptoms.

Depression is the most prevalent mental illness in the perinatal period, with research suggesting that around 10 to 14% of mothers are affected during pregnancy or after the birth of a baby. The key symptoms of depression include persistent sadness, fatigue and a loss of interest and enjoyment in activities. A number of studies have shown that many women who have postnatal depression have symptoms of depression in pregnancy, and can be identified in antenatal period. Better antenatal detection of depression therefore 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.

Public services are failing to tackle perinatal mental disorders effectively due to lack of mental healthcare providers. To achieve Sustainable Development Goal (SDG), mental health services must be available at the community level in low socioeconomic country like Bangladesh. Moreover, due to lack of necessary training the healthcare providers at primary and secondary level, the patients with mental health problems cannot get adequate services to meet the requirements. Again they fail to refer the severely ill patients to the appropriate referral centre. Mental health issues are the vital for maintaining quality of life of people in developing countries like Bangladesh.

In Bangladesh there is a strong community-based healthcare network such as union health and family welfare centers at the union levels, community clinics at community levels to provide essential healthcare services especially for mother and child. Along with this the community health workers also provide maternal services through satellite clinics, out-reach centers and home visit. It is evidenced that community based intervention like counseling and psycho-social therapy by the non-mental health specialists such as community health workers compared to the usual maternal care is associated with the reduction of symptoms of common perinatal mental disorders. So, maternal healthcare services are the appropriate ones for providing primary mental healthcare services. There is needed to provide basic mental healthcare services along with maternal healthcare services from the community level health centers as well as by the community health workers for improving perinatal mental health status in Bangladesh. Objectives of this study are a) to develop a draft package of community-based primary mental healthcare services, b) to find the feasibility of the developed package for delivering with the maternal care services, c) to test the efficacy of the package of community-based primary mental healthcare services and d) to document the healthcare seeking behavior for perinatal mental disorders.

Methods The investigators will conduct a mixed method study to develop a package of community-based primary mental healthcare services (CBPMHC). Initially a draft package of services will be developed. Then, piloting will be done as cluster randomized control trial to test the efficacy of the package. The draft CBPMHC services package will be the intervention.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control

Experimental

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.

Intervention: Community-Based Primary Mental Health Care (CBPMHC) package (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Number of still births among the study participant's fetus(18 months)
  • Number of low birth weight babies among the study participant's fetus(18 months)
  • Number of live births among the study participant's fetus(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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