Recruiting

Observational Study

Sponsor:

University of Regina

Code:

NCT06648382

Conditions

Premenstrual Disorder

Premenstrual Dysphoric Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Interventions

Self-directed psychotherapy program for premenstrual disorders

Study Details

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

Study ID

NCT06648382

Start date

Oct 15, 2024

Status verified date

Oct, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-directed psychotherapy program

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.

Interventions

Self-directed psychotherapy program for premenstrual disorders

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jennifer Gordon, PhD

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

Locations

University of Regina

Recruiting

Regina, Saskatchewan, Canada, S4S0A2

Contacts

Jennifer Gordon

3063514976jennifer.gordon@uregina.ca

More Information

Sponsor

University of Regina

Last update posted

Apr 6, 2025

Last verified

Oct, 2024

Keywords

  • Psychotherapy
  • Premenstrual disorder
  • Premenstrual dysphoric disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2025-04-06.