Testing Self-directed psychotherapy program for for premenstrual disorder
Official title: Pilot Study of the 'Thriving With PMDs' Program
Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders
- 1 group
- 2 sites in Regina
- Recruiting
Interventions
- Behavioural therapy
Self-directed psychotherapy program for premenstrual disorders
The intervention consists of receiving 11 videos that are 10-15 minutes in length along with a workbook containing homework exercises. Participants are instructed to watch the videos over the course of two menstrual cycles: the first 6 during the first cycle and the last 5 during the second cycle. Each module focuses on a different skill inspired by cognitive behavioral therapy and dialectical behavior therapy.
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan
- Not yet recruiting
University of Regina
Regina, Saskatchewan
Eligibility Criteria
See who this study is looking for4 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Ages 18-42
- +Either meeting diagnostic criteria for premenstrual dysphoric disorder (to be confirmed by researchers through daily symptom ratings for two menstrual cycles) or major depressive disorder with perimenstrual exacerbation (i.e. at least a 30% increase in 4 symptoms in the perimenstrual phase)
Exclusion
- −Currently in psychotherapy
- −Taking oral contraceptives
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Self-directed psychotherapy program for premenstrual disorders.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 42 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around October 2025.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 1 month post-intervention, 2 months post-intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 1 month post-intervention, 2 months post-intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06648382 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Self-directed psychotherapy program for premenstrual disordersBehavioural
The intervention consists of receiving 11 videos that are 10-15 minutes in length along with a workbook containing homework exercises. Participants are instructed to watch the videos over the course of two menstrual cycles: the first 6 during the first cycle and the last 5 during the second cycle. Each module focuses on a different skill inspired by cognitive behavioral therapy and dialectical behavior therapy.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 42 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 42 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 1 month post-intervention, 2 months post-intervention.
The study as a whole is currently expected to finish around 2025-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Regina, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.