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

Официальное название

Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder

Обзор

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.

Вмешательства

• Поведенческое Psychoeducation and Sleep-Informed Workshop
  The workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep.

Первичные конечные точки

• Insomnia Severity Index (ISI) [Срок оценки: Throughout the duration of the study (60 days), change will be assessed weekly.]
• Actigraphy watches [Срок оценки: Actigraphy watches will be worn daily for 60 days for all participants.]

Вторичные конечные точки (10)

• Consensus Sleep Diary (CSD) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
• Perceived Stress Scale (PSS) [Срок оценки: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]
• Premenstrual Coping Measure (PMCM) [Срок оценки: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• St Joseph's Healthcare Hamilton - West 5th Campus — Hamilton

Идентификаторы

NCT: NCT07554950 · 19661

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗