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Clinical Trials/NCT06648382
NCT06648382
Recruiting
N/A

Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders

University of Regina1 site in 1 country50 target enrollmentOctober 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premenstrual Disorder
Sponsor
University of Regina
Enrollment
50
Locations
1
Primary Endpoint
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2024
End Date
October 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Gordon

Associate professor

University of Regina

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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