Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms (ACT-PM)

Women's College Hospital

Status

Active, not recruiting

Conditions

Premenstrual Exacerbation of Mood Disorder

Premenstrual Dysphoric Disorder

Treatments

Behavioral: Acceptance and Commitment Therapy (ACT) Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06462391

WCH-24-001

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(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).

Exclusion criteria

(1) active alcohol or substance use disorder in the previous 12 months;
(2) active suicidal ideation, mania, psychosis, or violence;
(3) current pregnancy or planning a pregnancy during the duration of the study
(4) inability to complete group and/or study measures in English, necessary as the pilot group is only available in English at this time.