PMDD, PMS, Sleep Disturbances
Conditions
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.
Interventions
BEHAVIORALPsychoeducation and Sleep-Informed Workshop
The workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep.
Sponsors
St. Joseph's Healthcare Hamilton
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Throughout the duration of the study (60 days), change will be assessed weekly. | 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 will be worn daily for 60 days for all participants. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consensus Sleep Diary (CSD) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | 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) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | 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) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | 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) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | 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. |
| 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. | The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period. Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder. |
| Beck's Depression Inventory-II (BDI-II) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | The Beck Depression Inventory-II (BDI-II) is a widely used 21-item self-report measure that assesses the severity of depressive symptoms over the past two weeks. Participants rate each symptom domain on a 0-3 scale. The BDI-II demonstrates strong internal consistency and construct validity across clinical and non-clinical samples and is sensitive to changes in depressive symptom severity. |
| Difficulties in Emotion Regulation Skills (DERS) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | The DERS is a 36-item self-report scale designed to assess difficulties with emotion regulation. The DERS contains six subscales that measure: non-acceptance goals, impulse, awareness, strategies, and clarity. Items are rated on a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always, 91-100%), with higher scores reflecting greater difficulties regulating emotions. The DERS has demonstrated good internal consistency (α=0.86) and test-retest reliability (0.74). |
| Pain Catastrophizing Scale (PCS) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire commonly used to assess cognitive and emotional responses to pain, including rumination, magnification, and helplessness. Although the current study does not focus primarily on pain, individuals with PMDD often report heightened physical discomfort and pain-related distress during the late luteal phase; therefore, the PCS will help examine how catastrophic thinking about bodily discomfort may relate to sleep disturbances and mood symptoms. The PCS demonstrates excellent internal consistency and strong convergent validity with measures of emotional distress and has been validated in diverse populations. |
| Perceived Stress Scale (PSS) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | The Perceived Stress Scale (PSS-10) is a 10-item self-report instrument designed to measure the degree to which individuals perceive situations in their lives as stressful. The PSS is one of the most widely used stress measures, demonstrating strong reliability and validity in adult populations and sensitivity to changes in psychological distress. Because stress is strongly linked to sleep disruption and mood instability in PMDD, this measure will support understanding of how perceived stress levels relate to workshop outcomes. |
| Premenstrual Coping Measure (PMCM) | Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion. | The Premenstrual Coping Measure (PMCM) is a validated self-report questionnaire assessing coping strategies used by individuals to manage premenstrual symptoms, including emotional regulation, avoidance, self-care, and awareness-based approaches. The PMCM has demonstrated good internal consistency, factorial validity, and sensitivity to differences in coping patterns among individuals with varying levels of premenstrual distress. |
Countries
Canada
Contacts
CONTACTSheryl M Green, PhD, C.Psych
Outcome results
None listed