The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM) (NCT05627206) | Clinical Trial Compass
CompletedNot Applicable
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Zambia270 participantsStarted 2022-11-15
Plain-language summary
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.
Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.
This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women participating in ZamCharts parent study
* SRQ-20 \>7 (clinically significant symptoms of depression or/anxiety),
* not planning to move within the next 6 months,
* with capacity to consent
* not receiving current mental health care.
Exclusion Criteria:
* Women with active suicidal ideation (determined by Paykel=4 OR 5),
* severe substance use (ACOK-SUD \>4),
* mania or psychotic symptoms
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Mental health symptoms. SRQ-20
Timeframe: Change between Baseline (at enrollment) and 6 months after enrollment