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Could talk therapy ease severe PMS? new study tests virtual ACT group

NCT ID NCT06462391

Symptom relief Sponsor: Women's College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a virtual group therapy called Acceptance and Commitment Therapy (ACT) can help people with severe premenstrual mood symptoms like PMDD or premenstrual exacerbation of mood disorders. Researchers will enroll 50 participants to see if the program is feasible and acceptable. If it works, it could offer a new treatment option for those who struggle with these symptoms.

What this could mean

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

Active substance
Acceptance and Commitment Therapy (ACT) group therapy
What this could lead to
If successful, this could provide a new, accessible therapy option to help people with severe premenstrual mood symptoms better manage their condition.
What could go wrong
This is a small, early feasibility study with only 50 participants, so it cannot prove effectiveness. The therapy may not work for everyone, and results may not apply to broader populations.

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 50 people

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

Started

Dec 2024

Expected to finish

Dec 2026

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) diagnosed by the psychiatrist who conducted the initial assessment with either Premenstrual Dysphoric Disorder (PMDD), or a bipolar or depressive disorder where there is Premenstrual Exacerbation (PME), after 2-3 months of mood tracking using a validated evidenced based scale for premenstrual mood symptoms (McMaster Premenstrual And Mood Symptom Scale (MAC-PMSS) or similar; * (2) have internet access and a video-enabled device; * (3) residing in Ontario for the duration of the study, necessary because MDs and therapists who could deliver the intervention are all licensed provincially; * (4) regular menstrual cycles (\~21-35 days); and * (5) have a regularly treating physician (e.g. psychiatrist or primary care provider). Exclusion Criteria: * (1) active alcohol or substance use disorder in the previous 12 months; * (2) active suicidal ideation, mania, psychosis, or violence; * (3) current pregnancy or planning a pregnancy during the duration of the study * (4) inability to complete group and/or study measures in English, necessary as the pilot group is only available in English at this time.

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Conditions

The condition(s) this trial relates to.

premenstrual dysphoric disorder

As listed by the trial registrant

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

Premenstrual dysphoric disorder Premenstrual exacerbation of mood disorder

Contacts and locations

Locations

  • Women's College Hospital

    Toronto, Ontario, L5M6N8, Canada

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2, Canada

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