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New study tests sleep workshop as Drug-Free aid for PMDD

NCT ID NCT07554950

Symptom relief Sponsor: St. Joseph's Healthcare Hamilton 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a brief sleep-focused workshop for people with PMDD who have trouble sleeping. The workshop teaches about sleep and simple strategies to improve it. Researchers want to see if it's practical and helpful, using sleep diaries and activity watches. 72 participants will be recruited to try this non-medication approach.

What this could mean

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

Active substance
Psychoeducation and Sleep-Informed Workshop
What this could lead to
If it works, this could offer a non-medication option to improve sleep and mood for people with PMDD.
What could go wrong
This is a small, early-stage study testing feasibility, not effectiveness. The workshop may not work for everyone, and results may not apply to all with PMDD.

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 72 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

16 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. Aged 16 and above 2. positive screening for severe PMS and PMDD as per the Premenstrual Severity Screening Tool (PSST) 3. experiencing sleep difficulties captured by a score of 12 or greater on the Insomnia Severity Index (ISI) 4. reported regular menstrual cycle (average length of 25-35 days) 5. not taking psychoactive medication or oral contraceptives or a) participants must be on a stable in dose and type for at least 8 weeks prior to the start of the study and b) medications remain stable throughout the study 6. fluent in English, minimal grade 8 reading level to understand written materials 7. individuals must have access to a smart phone or tablet with stable internet connection in order to complete study daily questionnaires Exclusion Criteria: 1. Severe cognitive disability that could impact the understanding of the clinical questionnaires 2. a diagnosis of schizophrenia or any other primary psychotic disorder or current alcohol or substance use disorders 3. presence of any unstable medical conditions

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Conditions

The condition(s) this trial relates to.

Parasomnias polydactyly-myopia syndrome premenstrual dysphoric disorder sleep disorder

As listed by the trial registrant

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

PMDD PMS Sleep disturbances

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

  • St Joseph's Healthcare Hamilton - West 5th Campus

    Hamilton, Ontario, L8N3K7, Canada

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