Clinical trial NCT04650334: Collaborative Care for Perinatal Depression Care in Vietnam
Official title: Developing a Tailored Implementation Plan for Collaborative Care of Perinatal Depression in Vietnam
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-12-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Severe mental illness

Primary outcomes:
measure: Screening rates for perinatal depression
timeFrame: 4 months
measure: Rates of weekly use of a patient registry for systematic case review. Adherence to weekly use of patient registry for systematic case review
timeFrame: 4 months
measure: Patient participation in Thinking Healthy treatment
timeFrame: 4 months
measure: Persistence in Thinking Healthy treatment
timeFrame: 4 months
Secondary outcomes:
measure: Rate of clinical improvement in depression symptom scores
timeFrame: 4 months
Other outcomes:
Locations:
city: Cần Thơ
country: Vietnam
facility: My Khanh Commune Health Center
city: Cần Thơ
country: Vietnam
facility: Tan Thoi Commune Health Center
Study officials:
References: