Pilot Study of the 'Thriving With PMDs' Program

NCT06648382 | Recruiting

• 2 other identifiers: REB 2024-9166541
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Premenstrual Disorder; Premenstrual Dysphoric Disorder

Keywords

Psychotherapy; Premenstrual disorder; Premenstrual dysphoric disorder

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 1 month post-intervention, 2 months post-intervention

Study Arms (1)

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.

Behavioral: Self-directed psychotherapy program for premenstrual disorders

Interventions

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.

Self-directed psychotherapy program

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Taking oral contraceptives
• Currently in psychotherapy

Sponsors & Collaborators

• University of Regina: lead
• International Association for Premenstrual Disorders: collaborator

Study Sites (2)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

NOT YET RECRUITING

University of Regina

Regina, Saskatchewan, S4S0A2, Canada

RECRUITING

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jennifer Gordon, PhD

CONTACT

306-585-4389; jennifer.gordon@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: October 15, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)