Collaborative Care for Perinatal Depression Care in Vietnam

NCT ID: NCT04650334

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-07-31

Brief Summary

Depression is the most common medical disorder of pregnancy, and suicide, most frequently found in women with depression, is a major source of maternal mortality. Perinatal depression affects approximately 15% of women in pregnancy and the year postpartum and affects both women and their children, both medically and as a result of impairment in the ability to care for self and others. In low- and middle-income countries (LMICs) where food insecurity can be severe, growth stunting is seen among the infants of women with untreated depression. Fortunately, effective treatment of perinatal depression with antidepressant medications and evidence-based psychosocial interventions (such as collaborative care) mitigates these risks. Yet there are a range of obstacles within LMICs to the delivery of services for perinatal depression and maternal suicide prevention, including a lack of awareness of this disorder and related evidence-based treatments, stigma among patients and providers, scarcity of specialty mental health care providers, and the lack of health information technology supports for the longitudinal care of chronic illness.

Detailed Description

The investigators plan to use a participatory approach to systematically identify and adapt key elements of evidence-based models of perinatal depression care delivery to the cultural and health services context of Can Tho, Vietnam. Over the two-year study period the investigators will first develop a model, adapted from evidence-based approaches, for screening and treatment for women receiving perinatal care in community health centers as well as obstetric hospitals. Simultaneous exploration of potential implementation strategies to support and sustain this model in context will be identified along with the creation of a training and implementation toolkit for this setting. Using these strategies and tools the investigators will then carry out a pilot perinatal collaborative care study in a public health center and the prenatal care practice of the Can Tho Obstetric and Gynecologic Hospital. The results of this pilot will be used to revise and enhance the treatment model and related implementation tools. These will be used in subsequent trials of effectiveness and/or implementation broadly in the health care system of Can Tho. The investigators propose a mixed methods and participatory action research (PAR) developmental approach to tailor the standard collaborative care approach for the Can Tho city region of southern Vietnam. A linked capacity development program will work to develop the research skills of the Can Tho University of Medicine and Pharmacy (CTUMP) team through structured activities and interactions with investigators from the University of Washington.

Specific Aims: The specific aims of this proposed work, to be carried out over 2 years in health centers delivering perinatal care, are:

Aim 1 (Phase 1, months 1-12) Develop a tailored form of the collaborative care model of perinatal depression for the Can Tho health system context and an associated implementation plan and toolkit:

1. Carry out a participatory development effort to inform a collaborative care model for depression care and suicide prevention tailored to the existing health system infrastructure;

2. Identify potential strategies to support large scale implementation of this adapted model;

3. Develop an implementation toolkit to support this implementation.

Aim 2 (Phase 2 and Phase 3, months 13-24) Carry out a prospective pilot implementation study of the tailored collaborative care model and implementation approach:

1. Implement this model in perinatal care settings to assess the acceptability, feasibility, and costs of the model implementation toolkit via process and clinical outcome measures;

2. Revise and re-assess the model and implementation toolkit.

Aim 3 (Phase 1-3, months 1-24) Develop capacity in the Can Tho investigator team related to implementation science strategies to improve mental health care delivery:

1. Provide ongoing remote training of junior faculty at the CTUMP through ongoing feedback and involvement in the research efforts, completion of remote implementation research training, a monthly publication development meeting, and a journal club;

2. Conduct an annual in-person/virtual training addressing behavioral health integration and implementation science in Can Tho, Vietnam.

Conditions

Perinatal Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Perinatal Collaborative Care

Experimental: Perinatal Collaborative Care in Can Tho, Vietnam This is an active treatment arm consisting of 3 health centers receiving training in collaborative care and enrollment of a total of 100 perinatal patients into collaborative care.

Group Type: OTHER

Collaborative Care

Intervention Type: BEHAVIORAL

Health services intervention to implement a team based model of care for perinatal depression.

Interventions

Collaborative Care

Health services intervention to implement a team based model of care for perinatal depression.

Intervention Type: BEHAVIORAL

Other Intervention Names

Thinking Healthy

Eligibility Criteria

Inclusion Criteria

• eligible to be screened for depression during pregnancy and 1 year post partum

Exclusion Criteria

• Severe mental illness

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ian Bennett

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

My Khanh Commune Health Center

Can Tho, , Vietnam

Site Status: RECRUITING

Tan Thoi Commune Health Center

Can Tho, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Ian M Bennett, MD, PhD

Role: CONTACT

ibennett@uw.edu

610-659-4267

Facility Contacts

Pham Thi Tam, MD, PhD

Role: primary

Pham Thi Tam, MD, PhD

Role: primary

Other Identifiers

R21MH122345

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007369

Identifier Type: -

Identifier Source: org_study_id