Perinatal DepressionNCT04650334
Collaborative Care for Perinatal Depression Care in Vietnam
A study testing Collaborative Care in people with Perinatal Depression, run by University of Washington at 2 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Dec 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- eligible to be screened for depression during pregnancy and 1 year post partum
Who cannot join
- Severe mental illness
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites, 2 recruiting
- Recruiting
My Khanh Commune Health Center
Can Tho
Pham Thi Tam, MD, PhD
- Recruiting
Tan Thoi Commune Health Center
Can Tho
Pham Thi Tam, MD, PhD
About this study
Official title: Developing a Tailored Implementation Plan for Collaborative Care of Perinatal Depression in Vietnam
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.
Read the 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:
- 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;
- Identify potential strategies to support large scale implementation of this adapted model;
- 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:
- 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;
- 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:
- 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;
- Conduct an annual in-person/virtual training addressing behavioral health integration and implementation science in Can Tho, Vietnam.
- Conditions
- Perinatal Depression
- Being tested
- Collaborative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
Also called Thinking Healthy
Health services intervention to implement a team based model of care for perinatal depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (1)
Rate of clinical improvement in depression symptom scores
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ian Bennett, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650334
- Sponsor's protocol ID
- STUDY00007369
- Other IDs
- R21MH122345
- Status last verified
- Apr 2021
- First submitted
- 16 Jun 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Tailored Implementation Plan for Collaborative Care of Perinatal Depression in Vietnam
- ClinicalTrials.gov ID
- NCT04650334
- Acronym / sponsor ID
- STUDY00007369
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- Identify potential strategies to support large scale implementation of this adapted model;
- 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:
- 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;
- 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:
- 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;
- Conduct an annual in-person/virtual training addressing behavioral health integration and implementation science in Can Tho, Vietnam.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perinatal Collaborative Care | Other | Behavioral: Collaborative CareExperimental: 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- eligible to be screened for depression during pregnancy and 1 year post partum
Key exclusion criteria (1 listed)
- Severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative CareAlso: Thinking HealthyHealth services intervention to implement a team based model of care for perinatal depression. | Behavioural | Perinatal Collaborative Care |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Rate of clinical improvement in depression symptom scores
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care in people with Perinatal Depression, run by University of Washington at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian M Bennett, MD, PhD (610-659-4267, ibennett@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rates for perinatal depression (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.