Collaborative Care for Perinatal Depression Care in Vietnam

NCT04650334 | Unknown

• 2 other identifiers: STUDY00007369R21MH122345
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (4)

• Screening rates for perinatal depression

  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.

  4 months

• Rates of weekly use of a patient registry for systematic case review. Adherence to weekly use of patient registry for systematic case review

  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.

  4 months

• Patient participation in Thinking Healthy treatment

  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 months

• Persistence in Thinking Healthy treatment

  The rate of women who agree to participate in the Thinking Healthy treatment who complete all treatment sessions.

  4 months

Secondary Outcomes (1)

• Rate of clinical improvement in depression symptom scores

  4 months

Study Arms (1)

Perinatal Collaborative Care

OTHER

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

Interventions

Collaborative Care BEHAVIORAL

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

Also known as: Thinking Healthy

Perinatal Collaborative Care

Eligibility Criteria

• Age: 16 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Severe mental illness

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

My Khanh Commune Health Center

Can Tho, Vietnam

RECRUITING

Tan Thoi Commune Health Center

Can Tho, Vietnam

RECRUITING

Central Study Contacts

Ian M Bennett, MD, PhD

CONTACT

610-659-4267; ibennett@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: December 2, 2020
• Study Start: December 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

VN (2)