Pilot Study of the 'Thriving With PMDs' Program

Not Applicable

Recruiting

• Conditions: Premenstrual Disorder; Premenstrual Dysphoric Disorder

• Registration Number: NCT06648382
• Lead Sponsor: University of Regina

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• Taking oral contraceptives
• Currently in psychotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144)	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

Trial Locations

Locations (1)

University of Regina; 🇨🇦 Regina, Saskatchewan, Canada