New study aims to ease depression and anxiety in expecting and new mothers
NCT ID NCT06456307
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a stepped-care program to help pregnant women and new mothers who have depression or anxiety. About 3,000 women in Kenya will be screened and offered treatment that increases in intensity as needed. The goal is to improve mood and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,970 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pregnant and ≥28 weeks gestation * Attending ANC care at the facility * ≥14 years old * Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3) * Willing to return to the MCH and PMTCT clinic for study visits Exclusion Criteria: * Less than 28 weeks gestation * Any woman at high risk of self-harm based on a study self-harm assessment protocol, * Has cognitive impairments or psychotic symptoms
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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HomaBay, Siaya and Kisumu
RECRUITINGWestern Kenya, Kenya
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Kenyatta National Hospital
RECRUITINGNairobi, Kenya
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill ease severe postpartum depression?
- Can a Four-Session therapy course ease the mental load on parents of medically complex children?
- Can neighbors help ease depression in older adults?
- Can breathing inside a pyramid ease Diabetes-Related depression?
- Can a 20-Minute brain zap ease depression in pregnancy?