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.
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)
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
Parallel
Psychoeducation and Sleep-Informed Workshop
BehavioralThe workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep.
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.
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.
Consensus Sleep Diary (CSD)
The CSD was developed by a committee of experts with the aim of proposing a new improved and standardized sleep diary. This sleep diary will be filled out in the morning and includes questions such as (a) what time the participant went to bed, (b) what time they intended to sleep, (c) how long they were awake during the night, (d) what time they woke for the final time, (e) what time they got out of bed, and (f) how much sleep the participant got that night. From this data, we will derive time in bed, sleep onset latency, wakefulness after sleep onset, total sleep time, and sleep efficiency.
McMaster Premenstrual and Mood Symptom Scale (MAC-PMSS)
The MAC-PMSS is a 2-month prospective self-report questionnaire used to determine PMDD diagnosis (Frey et al, 2022). As mentioned previously, participants who screen positive for PMDD in the SCID-5 module will be tracked with the MAC-PMSS to confirm a prospective clinical diagnosis of PMDD. For individuals who do not meet criteria for PMDD will be categorized as having PMS, patients will continue to monitor their symptoms with the MAC-PMSS app because the study aims to run analyses on the symptoms reported compared to the daily consensus sleep diary and actigraphy data.
Biological Rhythm Interview of Assessment in Neuropsychiatry (BRIAN)
The BRIAN is a self-report assessment designed to assess five domains related to biological rhythms as follows: 1) sleep; 2) activity; 3) social; 4) eating patterns; 5) predominant patterns. The BRIAN contains 18-items rated using a 4-point scale, 1) no difficulty, 2) mild difficulty, 3) moderate difficulty, and 4) severe difficulty. The scale has a Cronbach's alpha of 0.93 and internal consistency of 0.93.
Functional Assessment Short Test (FAST)
The FAST is a 24-item self-report measure scored on a 5-point scale ranging from 0 ('no difficulty') to 4 ('severe difficulty'). The questionnaire contains 6 subscores: autonomy, occupational functioning, cognitive functioning, financial, interpersonal relationships, and leisure time. In this study, functional impairment will be assessed through the FAST pertaining to the impact of PMDD symptoms on various domains of life.
Sociodemographic Factors
Sociodemographic information collected will include participant's gender, age, ethnicity, marital status, education level, income level, parity, medical and delivery history, family psychiatric history, medication usage, and treatment history.
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St. Joseph's Healthcare Hamilton
Lead sponsor
McMaster University
Collaborator
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