Pilot Study of the 'Thriving With PMDs' Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-directed psychotherapy program for premenstrual disorders.
- Who it may be relevant to
- Registry conditions: Premenstrual Disorder, Premenstrual Dysphoric Disorder. Basic parameters: 18 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders
Overview
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.
Interventions
- Behavioral 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 measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- University of Regina — Regina
- University of Regina — Regina
Identifiers
NCT: NCT06648382 · REB 2024-916 · 6541