Sleep DisturbancesPMDDNCT07554950
Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder
A study testing Psychoeducation and Sleep-Informed Workshop in people with Sleep Disturbances and PMDD, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Sleep Disturbances, PMDD, PMS
- What is being tested?
- Psychoeducation and Sleep-Informed Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St Joseph's Healthcare Hamilton - West 5th Campus
Hamilton, Ontario, L8N3K7
Sheryl M Green, PhD, C. Psych, 905-522-1155 ext. 33672, sgreen@stjoes.ca
Alyssa Georgescu, HBSc., 4166666532, ageorges@stjoes.ca
About this study
Official title: Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder
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.
- Conditions
- Sleep Disturbances, PMDD, PMS
- Being tested
- Psychoeducation and Sleep-Informed Workshop
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation and Sleep-Informed WorkshopBehavioural
The workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Behavioral: Psychoeducation and Sleep-Informed Workshop |
| Waitlist | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the duration of the study (60 days), change will be assessed weekly.
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.
Measured: Actigraphy watches will be worn daily for 60 days for all participants.
Secondary outcomes (10)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.
Pain Catastrophizing Scale (PCS)
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.
Measured: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.
Perceived Stress Scale (PSS)
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.
Measured: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.
Premenstrual Coping Measure (PMCM)
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.
Measured: Throughout the duration of the study (60 days) change will be assessed 2 timepoints: at baseline and post-study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554950
- Sponsor's protocol ID
- 19661
- Acronym
- PMDD
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT07554950
- Acronym / sponsor ID
- PMDD / 19661
- Conditions
- Sleep Disturbances, PMDD, PMS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Psychoeducation and Sleep-Informed WorkshopIf 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. |
| Waitlist | No intervention | –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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation and Sleep-Informed WorkshopThe workshop will include education about PMDD, sleep physiology, sleep hygiene, and cognitive- behavioural strategies for improving sleep. | Behavioural | Treatment Group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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
Time frame: 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.
10 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Sleep-Informed Workshop in people with Sleep Disturbances and PMDD, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheryl M Green, PhD, C.Psych (905-522-1155 ext. 33672, sgreen@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Throughout the duration of the study (60 days), change will be assessed weekly.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.