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Talking it out: can midwives deliver mental health care for new mothers?

NCT ID NCT07800299

Symptom relief Sponsor: The Hong Kong Polytechnic University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests whether a midwife-led cognitive behavioral intervention can reduce depression, boost social support, and lower stress in pregnant women in Ethiopia. Pregnant women in their third trimester who screen positive for depression will receive either the seven-session group therapy plus usual care, or usual care alone. The therapy uses local language and examples to help women replace negative thoughts and engage in pleasant activities. Researchers will measure changes in depression, social support, and stress before, right after, and three months after the intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Midwife-led cognitive behavioral intervention
What this could lead to
If it works, this could offer a practical, low-cost way to treat perinatal depression in low-income settings, improving mental health for mothers and their children.
What could go wrong
This is a relatively small trial, and the intervention depends on midwives' training and delivery. Results may not apply to other regions, and the therapy may not reduce depression more than usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: 1. Women aged 18 or more years. 2. In the third trimester of pregnancy. 3. Speak and read the local Amharic language. 4. Women who screen positive for perinatal depression with an EPDS score ≥7. Exclusion Criteria: 1. EPDS score of ≥ 20. 2. Women with active suicidal ideation. 3. Participants with severe medical or obstetric conditions.

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Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perceived stress Perinatal depression Social support

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Addis Zemen Hospital

    Debre Tabor, South Gondar, Ethiopia

  • Debre Tabor specialised hospital

    Debre Tabor, South Gondar, Ethiopia

  • Wereta Hospital

    Debre Tabor, South Gondar, Ethiopia

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