Pilot Study of the 'Thriving With PMDs' Program

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.

Recruiting

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Key information

Conditions

Premenstrual Disorder Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Dysphoric Disorder Premenstrual Syndrome

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Regina, Regina, Saskatchewan, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-directed psychotherapy program for premenstrual disorders

Behavioral

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.

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 contacts

Contact information is provided by the study sponsor or research team.

Jennifer Gordon, PhD

CONTACT

[email protected]

306-585-4389

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

International Association for Premenstrual Disorders

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 18, 2024
Registry last updated: Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed