Psychoeducation and Sleep Workshop for Premenstrual Dysphoric Disorder

(PMDD Trial)

SM
Overseen BySheryl M Green, PhD, C.Psych
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: St. Joseph's Healthcare Hamilton
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Premenstrual Dysphoric Disorder (PMDD) is a cyclical mood disorder characterized by emotional, cognitive, physical, and sleep-related symptoms that occur in the days leading up to menstruation and improve shortly after menstruation begins. Although medications are commonly used to treat PMDD, many individuals experience side effects, do not benefit from medication, or prefer non-medication-based approaches. Sleep difficulties are very common in individuals with PMDD and may contribute to mood symptoms, emotional regulation difficulties, and functional impairment. Psychological interventions that focus on sleep, such as sleep psychoeducation and cognitive-behavioural strategies for insomnia, are effective in other mood and anxiety disorders but have not been well studied in PMDD. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored for individuals with PMDD or severe premenstrual symptoms. Information collected in this study may help inform future research and may improve care for individuals with PMDD.

Are You a Good Fit for This Trial?

Inclusion Criteria

2. positive screening for severe PMS and PMDD as per the Premenstrual Severity Screening Tool (PSST)
I am 16 years old or older.
3. experiencing sleep difficulties captured by a score of 12 or greater on the Insomnia Severity Index (ISI)
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Daily Monitoring

Participants complete 30 days of daily monitoring before attending the workshop

4 weeks
Daily self-reporting

Workshop

Participants attend a 90-minute virtual sleep-focused psychoeducation workshop

1 day
1 virtual visit

Post-Workshop Monitoring

Participants continue daily monitoring for an additional 30 days after the workshop

4 weeks
Daily self-reporting

Follow-up

Participants are monitored for safety and effectiveness after the study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Psychoeducation and Sleep-Informed Workshop

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment1 Intervention
Group II: WaitlistActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

McMaster University

Collaborator

Trials
936
Recruited
2,630,000+