Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder

NCT07554950 | Not Yet Recruiting

• 1 other identifier: 19661
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disturbances; PMDD; PMS

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI)

  Description: The ISI is a 7-item self-report questionnaire that assesses the nature, severity, and impact of insomnia. Items are scored on a 5-point Likert scale ranging from 0 ('no problem') to 4 ('very severe problem') with higher scores reflecting greater insomnia severity. Total scores between 0-7 indicate an absence of insomnia; scores between 8-14 suggest sub-threshold insomnia; scores between 15-21 indicate moderate insomnia; and scores between 22-28 suggest severe insomnia. The ISI has demonstrated good psychometric properties.

  Throughout the duration of the study (60 days), change will be assessed weekly.

• Actigraphy watches

  Actigraphy watches are wrist-worn and battery-operated activity monitors that look similar to a small wristwatch. These devices are equipped with an accelerometer, measuring activity patterns and estimating sleep. They can be employed as an adjunctive measure in the diagnosis and treatment of insomnia to improve the reliability of self-report estimates of sleep.

  Actigraphy watches will be worn daily for 60 days for all participants.

Secondary Outcomes (10)

• Consensus Sleep Diary (CSD)

  Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.

• McMaster Premenstrual and Mood Symptom Scale (MAC-PMSS)

  Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.

• Biological Rhythm Interview of Assessment in Neuropsychiatry (BRIAN)

  Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.

• Functional Assessment Short Test (FAST)

  Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.

• Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.

Other Outcomes (1)

• Sociodemographic Factors

  Throughout the duration of the study (60 days), change will be assessed at baseline and post-study assessment.

Study Arms (2)

Treatment Group

EXPERIMENTAL

If you are assigned to the treatment group, you will complete 30 days of daily monitoring before attending one 90-minute virtual sleep-focused psychoeducation workshop led by a trained graduate student under the supervision of a senior licensed clinical psychologist, Dr. Sheryl M. Green. The workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep. After the workshop, you will continue daily monitoring for an additional 30 days.

Behavioral: Psychoeducation and Sleep-Informed Workshop

Waitlist

NO INTERVENTION

If you are assigned to the waitlist group, you will complete the same 60 days of daily monitoring but will not receive the workshop during the study period. You will be offered the opportunity to participate in the workshop after completing the study, if you are interested.

Interventions

Psychoeducation and Sleep-Informed Workshop BEHAVIORAL

The workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep.

Treatment Group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 16 and above
• positive screening for severe PMS and PMDD as per the Premenstrual Severity Screening Tool (PSST)
• experiencing sleep difficulties captured by a score of 12 or greater on the Insomnia Severity Index (ISI)
• reported regular menstrual cycle (average length of 25-35 days)
• 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
• fluent in English, minimal grade 8 reading level to understand written materials
• individuals must have access to a smart phone or tablet with stable internet connection in order to complete study daily questionnaires

You may not qualify if:

• Severe cognitive disability that could impact the understanding of the clinical questionnaires
• a diagnosis of schizophrenia or any other primary psychotic disorder or current alcohol or substance use disorders
• presence of any unstable medical conditions

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton - West 5th Campus

Hamilton, Ontario, L8N3K7, Canada

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Sheryl M Green, PhD, C.Psych

CONTACT

905-522-1155; sgreen@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Clinical Psychologist

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)