Pilot Study of the 'Thriving With PMDs' Program

University of Regina

Status: Enrolling

Conditions: Premenstrual Dysphoric Disorder; Premenstrual Disorder

Treatments: Behavioral: Self-directed psychotherapy program for premenstrual disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT06648382

6541 (Other Grant/Funding Number)

REB 2024-916

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Self-directed psychotherapy program

Experimental group

Description:

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.

Treatment:

Behavioral: Self-directed psychotherapy program for premenstrual disorders