Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms: An Open-label Feasibility Study of ACT-PM

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In the weeks prior to menstruation, many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning. Approximately 5% of women and menstruating individuals have such severe symptoms that they meet criteria for Premenstrual Dysphoric Disorder (PMDD). Further, of those with underlying mood disorders (i.e., depression, bipolar disorder) about 60% have cyclical worsening of symptoms classified as premenstrual exacerbation (PME). Both PMDD and PME are associated with significant impairment, yet limited effective options exist to treat these conditions. In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT-Premenstrual (ACT-PM), delivered virtually to maximize accessibility. The investigators will examine whether ACT-PM is feasible to deliver and whether it is acceptable to group participants and those facilitating the group. The study will lay the groundwork for future research to determine if the group is effective. If effective, the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from PMDD and PME.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• (1) diagnosed by the psychiatrist who conducted the initial assessment with either Premenstrual Dysphoric Disorder (PMDD), or a bipolar or depressive disorder where there is Premenstrual Exacerbation (PME), after 2-3 months of mood tracking using a validated evidenced based scale for premenstrual mood symptoms (McMaster Premenstrual And Mood Symptom Scale (MAC-PMSS) or similar;

• (2) have internet access and a video-enabled device;

• (3) residing in Ontario for the duration of the study, necessary because MDs and therapists who could deliver the intervention are all licensed provincially;

• (4) regular menstrual cycles (\

⁃ 21-35 days); and

• (5) have a regularly treating physician (e.g. psychiatrist or primary care provider).

Locations
Other Locations
Canada
Women's College Hospital
RECRUITING
Toronto
Women's College Hospital
RECRUITING
Toronto
Contact Information
Primary
Elisabeth Wright, MD
elisabeth.wright@wchospital.ca
416 323 6400
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Other: single arm (open label)
all participants will be in pilot psychotherapy group
Sponsors
Leads: Women's College Hospital

This content was sourced from clinicaltrials.gov