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

NCT03678415 | Completed

• 1 other identifier: PR-17042
• Study Type: interventional
• Target: 1,210
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Keywords

Depression, anxiety and stress

Outcome Measures

Primary Outcomes (1)

• Number of study participants with depression, anxiety and stress in perinatal period

  Investigators assume developed intervention helps to prevent mental health disorders

  18 months

Secondary Outcomes (3)

• Number of live births among the study participant's fetus

  18 months

• 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

Study Arms (1)

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.

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

Interventions

Community-Based Primary Mental Health Care (CBPMHC) package BEHAVIORAL

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.

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

ICDDR,B

Dhaka, 1000, Bangladesh

Location

Related Publications (17)

• Gruebner O, Khan MM, Lautenbach S, Muller D, Kramer A, Lakes T, Hostert P. Mental health in the slums of Dhaka - a geoepidemiological study. BMC Public Health. 2012 Mar 9;12:177. doi: 10.1186/1471-2458-12-177.

  PMID: 22404959 RESULT

• Hossain MD, Ahmed HU, Chowdhury WA, Niessen LW, Alam DS. Mental disorders in Bangladesh: a systematic review. BMC Psychiatry. 2014 Jul 30;14:216. doi: 10.1186/s12888-014-0216-9.

  PMID: 25073970 RESULT

• Deuchar N. New Joint Commissioning panel for mental health could help GPs to commission mental health services more effectively. Ment Health Today. 2011 Jun:9. No abstract available.

  PMID: 21850743 RESULT

• Oates M. Perinatal maternal mental health services. Recommendations for provision of services for childbearing women. London: Royal College of Psychiatrists. 2001

  RESULT

• O'Hara MW, Swain AM. Rates and risk of postpartum depression - a meta-analysis. Int Rev Psychiatry, 1996; 8:37-54

  RESULT

• Teixeira C, Figueiredo B, Conde A, Pacheco A, Costa R. Anxiety and depression during pregnancy in women and men. J Affect Disord. 2009 Dec;119(1-3):142-8. doi: 10.1016/j.jad.2009.03.005. Epub 2009 Apr 5.

  PMID: 19346001 RESULT

• Heron J, O'Connor TG, Evans J, Golding J, Glover V; ALSPAC Study Team. The course of anxiety and depression through pregnancy and the postpartum in a community sample. J Affect Disord. 2004 May;80(1):65-73. doi: 10.1016/j.jad.2003.08.004.

  PMID: 15094259 RESULT

• Josefsson A, Berg G, Nordin C, Sydsjo G. Prevalence of depressive symptoms in late pregnancy and postpartum. Acta Obstet Gynecol Scand. 2001 Mar;80(3):251-5. doi: 10.1034/j.1600-0412.2001.080003251.x.

  PMID: 11207491 RESULT

• Ramchandani P, Stein A, Evans J, O'Connor TG; ALSPAC study team. Paternal depression in the postnatal period and child development: a prospective population study. Lancet. 2005 Jun 25-Jul 1;365(9478):2201-5. doi: 10.1016/S0140-6736(05)66778-5.

  PMID: 15978928 RESULT

• Ramchandani PG, Psychogiou L, Vlachos H, Iles J, Sethna V, Netsi E, Lodder A. Paternal depression: an examination of its links with father, child and family functioning in the postnatal period. Depress Anxiety. 2011 Jun;28(6):471-7. doi: 10.1002/da.20814. Epub 2011 Apr 19.

  PMID: 21506206 RESULT

• 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.

  RESULT

• Center on the Developing Child at Harvard University. Maternal Depression Can Undermine the Development of Young Children: 2009; Working Paper No. 8

  RESULT

• World Health organization. Health in 2015: from MDGs, Millennium Development Goals to SDGs, Sustainable Development Goals. WHO 2015

  RESULT

• Clarke K, King M, Prost A. Psychosocial interventions for perinatal common mental disorders delivered by providers who are not mental health specialists in low- and middle-income countries: a systematic review and meta-analysis. PLoS Med. 2013 Oct;10(10):e1001541. doi: 10.1371/journal.pmed.1001541. Epub 2013 Oct 29.

  PMID: 24204215 RESULT

• 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

  RESULT

• Morrell CJ, Warner R, Slade P, Dixon S, Walters S, Paley G, Brugha T. Psychological interventions for postnatal depression: cluster randomised trial and economic evaluation. The PoNDER trial. Health Technol Assess. 2009 Jun;13(30):iii-iv, xi-xiii, 1-153. doi: 10.3310/hta13300.

  PMID: 19555590 RESULT

• Dutta GK, Ahmed HU, Talukder MQ, Bhattacharyya DS, Reza MS, Rahman MM, Majumdar R, Tofail F, Perry HB, Biswas TK. Effectiveness of a package of community-based mental healthcare services to address perinatal mental disorders in Bangladesh: A cluster-randomized controlled trial. Asian J Psychiatr. 2024 Dec;102:104290. doi: 10.1016/j.ajp.2024.104290. Epub 2024 Oct 25.

  PMID: 39500096 DERIVED

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Interventions

Drug Packaging

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: September 19, 2018
• Study Start: April 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 26, 2019

Record last verified: 2018-06

Locations

BA (1)