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New social therapy aims to lift postpartum depression by fighting isolation

NCT ID NCT05585164

Symptom relief Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a new type of talk therapy called Engage & Connect for mothers with postpartum depression. The therapy focuses on helping moms plan and do rewarding social activities to reduce feelings of isolation. Sixty participants will receive either this new therapy or a standard education session, both delivered remotely over 9 weeks. Researchers will measure changes in depression severity and social engagement.

What this could mean

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

Active substance
Engage & Connect psychotherapy (behavioral intervention)
What this could lead to
If it works, this could offer a new, non-drug treatment option for postpartum depression that helps new mothers feel less isolated.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. The therapy is compared to another talk therapy, so the difference may be small.

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 60 people

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

Started

Nov 2022

Expected to finish

Jul 2030

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Up to 1 year post-delivery 2. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10. 3. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks. 4. Capacity to provide consent for research assessment and treatment. 5. Speaks English proficiently Exclusion Criteria: 1. Intent or plan to attempt suicide in the near future 2. Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention) 3. Active substance abuse or dependence 4. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy 5. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia. 6. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.

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Conditions

The condition(s) this trial relates to.

postpartum depression

As listed by the trial registrant

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

Postpartum depression

How to take part

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

  1. The places running it

    1 site. 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

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10022, United States

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