Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychoeducation and Sleep-Informed Workshop.
- Who it may be relevant to
- Registry conditions: Sleep Disturbances, PMDD, PMS. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder
Overview
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
- Behavioral Psychoeducation and Sleep-Informed Workshop
The workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep.
Primary outcome measures
- Insomnia Severity Index (ISI) [Time frame: Throughout the duration of the study (60 days), change will be assessed weekly.]
- Actigraphy watches [Time frame: Actigraphy watches will be worn daily for 60 days for all participants.]
Secondary outcome measures (10)
- Consensus Sleep Diary (CSD) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
- Beck's Depression Inventory-II (BDI-II) [Time frame: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
- Difficulties in Emotion Regulation Skills (DERS) [Time frame: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
- Pain Catastrophizing Scale (PCS) [Time frame: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
- Perceived Stress Scale (PSS) [Time frame: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
- Premenstrual Coping Measure (PMCM) [Time frame: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- St Joseph's Healthcare Hamilton - West 5th Campus — Hamilton
Identifiers
NCT: NCT07554950 · 19661