Premenstrual DisorderNCT06648382
Pilot Study of the 'Thriving With PMDs' Program
A study testing Self-directed psychotherapy program for premenstrual disorders in people with Premenstrual Disorder and Premenstrual Dysphoric Disorder, run by University of Regina at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Premenstrual Disorder, Premenstrual Dysphoric Disorder
- What is being tested?
- Self-directed psychotherapy program for premenstrual disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Oct 2024to Oct 2025
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Taking oral contraceptives
- Currently in psychotherapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Regina
Regina, Saskatchewan, S4S 0A2
Jennifer Gordon, PhD, 306-585-4389, jennifer.gordon@uregina.ca
- Recruiting
University of Regina
Regina, Saskatchewan, S4S0A2
Jennifer Gordon, 3063514976, jennifer.gordon@uregina.ca
About this study
Official title: Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders
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.
- Being tested
- Self-directed psychotherapy program for premenstrual disorders
- Keywords
- Psychotherapy, Premenstrual disorder, Premenstrual dysphoric disorder
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed psychotherapy program | Experimental | 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. Receives: Behavioral: Self-directed psychotherapy program for premenstrual disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144)
Perimenstrual DRSP score during the two post-intervention menstrual cycles relative to the two pre-intervention menstrual cycles
Measured: Baseline, 1 month post-intervention, 2 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start15 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- International Association for Premenstrual Disorders
- Responsible party
- Principal investigator, Jennifer Gordon, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648382
- Sponsor's protocol ID
- REB 2024-916
- Other IDs
- 6541
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected is sensitive in nature - there are many questions about suicidality and urges to self harm as well as experiences with traumatic events. We do not want to make participants feel uncomfortable by making their data publically available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders
- ClinicalTrials.gov ID
- NCT06648382
- Acronym / sponsor ID
- REB 2024-916
- Keywords
- Psychotherapy, Premenstrual disorder, Premenstrual dysphoric disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- International Association for Premenstrual Disorders
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-directed psychotherapy program | Experimental | Behavioral: Self-directed psychotherapy program for premenstrual disordersThe 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Taking oral contraceptives
- Currently in psychotherapy
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 |
|---|---|---|
| Self-directed psychotherapy program for premenstrual disordersThe 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. | Behavioural | Self-directed psychotherapy program |
Primary outcome
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144)
Time frame: Baseline, 1 month post-intervention, 2 months post-intervention
Perimenstrual DRSP score during the two post-intervention menstrual cycles relative to the two pre-intervention menstrual cycles
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 6 Apr 2025.
- Individual participant dataSharing planned: No. The data collected is sensitive in nature - there are many questions about suicidality and urges to self harm as well as experiences with traumatic events. We do not want to make participants feel uncomfortable by making their data publically available.
Related trials for Premenstrual Disorder
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
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RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
The Effect of Mandala Coloring, Sleep Quality, Anxiety With Premenstrual Syndrome
Premenstrual Syndrome
Not yet recruitingObservational study
The SPARK-PMDD Study
Premenstrual Dysphoric Disorder, PMDD
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-directed psychotherapy program for premenstrual disorders in people with Premenstrual Disorder and Premenstrual Dysphoric Disorder, run by University of Regina at 2 sites 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jennifer Gordon, PhD (306-585-4389, jennifer.gordon@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144) (time frame: Baseline, 1 month post-intervention, 2 months post-intervention). 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 6 Apr 2025.