Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment Group
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.
干预措施: Psychoeducation and Sleep-Informed Workshop (Behavioral)
Waitlist
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.
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- Pain Catastrophizing Scale (PCS)(Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.)
- Perceived Stress Scale (PSS)(Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.)
- Premenstrual Coping Measure (PMCM)(Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.)
研究者
Sheryl Green
Associate Professor and Clinical Psychologist
St. Joseph's Healthcare Hamilton