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

NCT06462391 | Active Not Recruiting

• 1 other identifier: WCH-24-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Premenstrual Dysphoric Disorder; Premenstrual Exacerbation of Mood Disorder

Outcome Measures

Primary Outcomes (10)

• Feasibility of recruitment and enrollment: number of participants referred

  Tracking to see how many referrals are made to the study

  Screening and baseline

• Feasibility of recruitment and enrollment: number of participants eligible

  Tracking number of participants that were eligible out of the number that was referred

  Screening and baseline

• Feasibility of recruitment and enrollment to study: number of participants enrolled

  Tracking number of participants that enrolled into the study

  Screening and baseline

• Feasibility of recruitment and enrollment to study: reasons for non-participation

  Tracking number of participants who did not enroll into the study and any reasons given by these participants

  Screening and baseline

• Adoption outcome: group attendance

  Tracking group attendance per session

  During intervention, post-intervention (after 8 weeks of intervention)

• Adoption outcome: group completion

  Tracking how many participants completed the group

  During intervention, post-intervention (after 8 weeks of intervention)

• Adoption outcome: reasons for non-completion

  Tracking the reasons why participants did not complete the group

  During intervention, post-intervention (after 8 weeks of intervention)

• Acceptability outcome

  Determining the acceptability of the program among participants and facilitators via questionnaires about their experience in the program.

  Post-intervention (after 8 weeks of intervention), and at 3-month follow-up

• Adherence with intervention protocol: therapist adherence

  (1) assessing therapist adherence to ACT-PM intervention via self-report from therapists and (2) independent rater review of 10% of audio tapes of sessions using ACT-FM (The ACT Fidelity Measure)

  During and post-intervention (after 8 weeks of intervention)

• Adherence with intervention protocol: completion of participant questionnaires

  Tracking number of participants who completed data collection measures (i.e.. acceptability questionnaire, and clinical scales - described below)

  Baseline, during intervention, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

Secondary Outcomes (8)

• Exploratory clinical symptoms outcome: McMaster Premenstrual And Mood Symptom Scale (MAC PMSS)

  Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

• Exploratory clinical symptoms outcome: Premenstrual Symptoms Screening Tool (PSST)

  Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

• Exploratory clinical symptoms outcome: The Patient Health Questionnaire-9 (PHQ-9)

  Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

• Exploratory clinical symptoms outcome: The Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

• Exploratory clinical symptoms outcome: The Acceptance and Action Questionnaire (AAQ-II)

  Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

Study Arms (1)

single arm (open label)

OTHER

all participants will be in pilot psychotherapy group

Behavioral: Acceptance and Commitment Therapy (ACT) Group

Interventions

Acceptance and Commitment Therapy (ACT) Group BEHAVIORAL

Psychotherapy group (delivered virtually)

single arm (open label)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (2)

Women's College Hospital

Toronto, Ontario, L5M6N8, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Principal Investigator

Model Details: open label pilot feasibility study

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 17, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)