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?

This trial explores a new approach to assist individuals with Premenstrual Dysphoric Disorder (PMDD) by enhancing sleep and mood without medication. Participants will attend a Psychoeducation and Sleep-Informed Workshop that teaches improved sleep habits and insomnia management techniques. This trial suits those with severe PMS or PMDD who experience regular sleep issues and maintain a steady menstrual cycle. Researchers will monitor participants daily for 60 days, with half attending the workshop and half on a waitlist, who can join the workshop later. As an unphased trial, this study offers a unique opportunity to contribute to innovative research aimed at improving the quality of life for PMDD sufferers.

Do I have to stop taking my current medications for the trial?

If you are taking psychoactive medication or oral contraceptives, you must have been on a stable dose and type for at least 8 weeks before the study starts and continue with the same dose throughout the study.

What prior data suggests that this psychoeducation and sleep-informed workshop is safe for individuals with PMDD?

Research has shown that psychoeducation and cognitive-behavioral therapy (CBT) for sleep are generally safe and well-tolerated. One study found that CBT techniques used in a psychoeducation workshop reduced premenstrual symptoms without significant side effects. These workshops educate participants about PMDD, sleep habits, and strategies to improve sleep.

The safety of these methods is further supported by their use in treating other mood and anxiety disorders. By not using medication, this workshop avoids the side effects associated with drugs. Overall, psychological treatments like this have a strong safety record.12345

Why are researchers excited about this trial?

Researchers are excited about the Psychoeducation and Sleep-Informed Workshop for Premenstrual Dysphoric Disorder (PMDD) because it offers a unique approach compared to standard treatments like antidepressants and hormonal therapies. This workshop combines psychoeducation about PMDD and sleep physiology with cognitive-behavioral strategies, aiming to improve sleep hygiene and overall mood. Unlike medication-based treatments, this method focuses on empowering participants with knowledge and practical skills that may lead to long-lasting benefits without the potential side effects of drugs. Additionally, the virtual format makes it accessible and convenient for participants to engage in, potentially reaching a wider audience in need of support.

What evidence suggests that this psychoeducation and sleep workshop is effective for PMDD?

Research has shown that certain strategies to improve sleep can help reduce symptoms of mood and anxiety disorders. One study found that teaching sessions combined with sleep-focused techniques significantly reduced premenstrual symptoms in participants. Another study demonstrated that these educational sessions led to a noticeable decrease in the severity of premenstrual syndrome. In this trial, participants in the treatment group will attend a workshop focused on improving sleep, which might help with symptoms of Premenstrual Dysphoric Disorder (PMDD). Enhancing sleep through education may improve mood and lessen the impact of PMDD.16789

Are You a Good Fit for This Trial?

This trial is for women and individuals aged 16 or older who have severe premenstrual symptoms or PMDD, regular menstrual cycles, trouble sleeping, can read English at a grade 8 level, and have access to a smartphone or tablet with internet. Participants should not be changing psychoactive medications or birth control during the study.

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

Trial Overview

The study tests whether a brief online workshop that teaches about sleep and ways to improve it can help people with PMDD or severe PMS manage their sleep problems. The focus is on non-medication strategies like psychoeducation and cognitive-behavioral techniques.

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+

Citations

Evaluating the Impact of Psychoeducation and Sleep ...

This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored ...

Psychoeducation and Sleep Workshop for Premenstrual ...

This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored ...

Emotion regulation-based internet-delivered cognitive ... - PMC

Another RCT on ICBT for PMS conducted on a student population showed a significant decrease in premenstrual symptoms after treatment. Yet, ...

Psychotherapy Modalities for Premenstrual Change

Emotion-focused group therapy among women with premenstrual dysphoric disorder: A randomized clinical trial. Psychotherapy Research, 32(4) ...

Development and implementation of mindfulness-based ...

The need assessment results showed that 19% of students met the criteria of PMDD symptoms, and 43% experienced moderate to high PMS. Above 50% experienced a low ...

Pre-Menstrual Dysphoric Disorder (PMDD) in Young People

We aim to explain more about PMDD in young people and explore the evidence looking at the role of CBT as an intervention.

delivered cognitive behavioural therapy for premenstrual ...

ABSTRACT. Introduction Premenstrual dysphoric disorder (PMDD) is a cyclic mood disorder affecting around 2%–5% of women of reproductive age.

The effect of cognitive behavioural psycho-education on ...

At the end of the study there was statistically significant decrease in severity of total PMS in intervention compared with control group ( P < 0.001). Also, a ...

Premenstrual Dysphoric Disorder

Approximately 80% of women report at least mild premenstrual symptoms, 20% to 50% report moderate to severe premenstrual symptoms, and 5% ...