Package of Community-based Mental Healthcare Services in Preventing Perinatal Mental Disorders
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|ClinicalTrials.gov Identifier: NCT03678415|
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : August 26, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
- 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
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
|Dhaka, Bangladesh, 1000|