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

NCT ID: NCT06462391

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Premenstrual Dysphoric Disorder Premenstrual Exacerbation of Mood Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open label pilot feasibility study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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single arm (open label)

all participants will be in pilot psychotherapy group

Group Type OTHER

Acceptance and Commitment Therapy (ACT) Group

Intervention Type BEHAVIORAL

Psychotherapy group (delivered virtually)

Interventions

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Acceptance and Commitment Therapy (ACT) Group

Psychotherapy group (delivered virtually)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth Wright

Psychiatrist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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WCH-24-001

Identifier Type: -

Identifier Source: org_study_id