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Collaborative Care for Perinatal Depression Care in Vietnam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04650334
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : April 28, 2021
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ian Bennett, University of Washington

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.

Condition or disease Intervention/treatment Phase
Perinatal Depression Behavioral: Collaborative Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Developing a Tailored Implementation Plan for Collaborative Care of Perinatal Depression in Vietnam
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Behavioral: Collaborative Care
Health services intervention to implement a team based model of care for perinatal depression.
Other Name: Thinking Healthy

Primary Outcome Measures :
  1. Screening rates for perinatal depression [ Time Frame: 4 months ]
    The rates of screening for perinatal depression by the clinical team will be determined. The rates of reported scores on the validated Vietnamese translation of the Patient Health Questionnaire - 9 item (PHQ-9) measure will be recorded for women receiving care at the study clinics. The scale ranges from 0-27 and a higher score is worse than lower however the completion of the survey is all that is required for this measure and not the total score. Women eligible for screening are those in pregnancy and 12 months postpartum. A total of 4 screenings are expected in this period - one in the first two trimesters of pregnancy and one in the third trimester and one in each of the six month periods following delivery. The rate will be reported for all eligible women (those in each of the above periods) who received a screening.

  2. Rates of weekly use of a patient registry for systematic case review. Adherence to weekly use of patient registry for systematic case review [ Time Frame: 4 months ]
    The use of the Care Manager Tracking System patient registry for weekly systematic case reviews will be assessed. Updated cases within the registry, preparation for case review, and documentation of treatment changes of patients will be assessed. The use of this tool for each week of the pilot study will be assessed.

  3. Patient participation in Thinking Healthy treatment [ Time Frame: 4 months ]
    The number of women who screen positive for risk of perinatal depression (PHQ-9 greater than or equal to 10) who agree to participate in the Thinking Healthy treatment program.

  4. Persistence in Thinking Healthy treatment [ Time Frame: 4 months ]
    The rate of women who agree to participate in the Thinking Healthy treatment who complete all treatment sessions.

Secondary Outcome Measures :
  1. Rate of clinical improvement in depression symptom scores [ Time Frame: 4 months ]
    Depression symptom scores among patients will be collected using the Patient Health Questionnaire - 9 item (PHQ-9) measure. This scale allows scores from 0-27 and a higher score is worse (greater symptomatology). The rate of patients with 50% reduction in symptoms will be determined as a measure of clinically significant improvement.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe mental illness

Information from the National Library of Medicine

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 identifier (NCT number): NCT04650334

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Contact: Ian M Bennett, MD, PhD 610-659-4267

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My Khanh Commune Health Center Recruiting
Cần Thơ, Vietnam
Contact: Pham Thi Tam, MD, PhD         
Tan Thoi Commune Health Center Recruiting
Cần Thơ, Vietnam
Contact: Pham Thi Tam, MD, PhD         
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
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Responsible Party: Ian Bennett, Professor, University of Washington Identifier: NCT04650334    
Other Study ID Numbers: STUDY00007369
R21MH122345 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases