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Premenstrual Dysphoric DisorderACT-PMNCT06462391

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

A study testing Acceptance and Commitment Therapy (ACT) Group in people with Premenstrual Dysphoric Disorder and Premenstrual Exacerbation of Mood Disorder, run by Women's College Hospital at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Acceptance and Commitment Therapy (ACT) Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesCanada
Study dates
1 Dec 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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).

Who cannot join

  • (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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Women's College Hospital

    Toronto, Ontario, L5M6N8

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

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

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.

Being tested
Acceptance and Commitment Therapy (ACT) Group
Medical subject headings
Premenstrual Dysphoric Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT) GroupBehavioural

    Psychotherapy group (delivered virtually)

Study groups in NCT06462391
Study groupRoleWhat they receive
single arm (open label)Otherall participants will be in pilot psychotherapy group
Receives: Behavioral: Acceptance and Commitment Therapy (ACT) Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment and enrollment: number of participants referred

    Tracking to see how many referrals are made to the study

    Measured: Screening and baseline

  2. Feasibility of recruitment and enrollment: number of participants eligible

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

    Measured: Screening and baseline

  3. Feasibility of recruitment and enrollment to study: number of participants enrolled

    Tracking number of participants that enrolled into the study

    Measured: Screening and baseline

  4. 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

    Measured: Screening and baseline

  5. Adoption outcome: group attendance

    Tracking group attendance per session

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

  6. Adoption outcome: group completion

    Tracking how many participants completed the group

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

  7. Adoption outcome: reasons for non-completion

    Tracking the reasons why participants did not complete the group

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

  8. Acceptability outcome

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

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

  9. 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)

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

  10. 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)

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

Secondary outcomes (8)

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

    Individuals can track their mood and premenstrual symptoms on a daily basis using the validated and self-reported McMaster Premenstrual And Mood Symptom Scale (MAC PMSS). The MAC PMSS consists of two charts 1) mood symptom chart, 2) premenstrual symptom chart with severity scores ranging from 1 (not at all) to 6 (extreme). Higher scores indicate a worse outcome.

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

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

    Premenstrual Symptoms Screening Tool (PSST) is a validated questionnaire which consists of 19 questions regarding how symptoms interfere with relationships and daily activities -14 questions are related to premenstrual symptoms, and 5 questions that measure the severity of interference of the symptoms on a woman's ability to function. The scale of each item ranges 0-3: not at all (0); mild (1); moderate (2); severe (3). Higher scores indicate a worse outcome.

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

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

    9-item assessment for depression, with scores indicating how often symptoms are bothersome, ranging from 0 (not at all) to 3 (nearly every day). Higher scores indicate a worse outcome.

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

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

    The GAD-7 a 7-item well-validated self-report scale which can aid in diagnosis and severity assessment for anxiety disorders (including GAD, social anxiety disorder, post-traumatic stress disorder, panic disorder). It is sensitive to change across treatment. Score ranges are from 0-21, with scores of 0-4 representing minimal, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety symptoms.

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

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

    The AAQ-II is a 7-item self-report scale that assesses constructs relating to acceptance, experiential avoidance, and psychological inflexibility, which are targets of Acceptance and Commitment Therapy (ACT). It has demonstrated satisfactory reliability and validity, has been validated in psychiatric populations, and scores are predictive of mental health and functional outcomes. Higher scores indicate less (worse) flexibility.

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

  6. Exploratory clinical symptoms outcome: The Mindfulness Attention Awareness Scale (MAAS)

    The MAAS is a 15-item self-report scale-used previously in both ACT and PMS research-to assess components of mindfulness such as present-moment awareness and observing capacity, which are considered transdiagnostic processes underlying various forms of psychopathology. Higher scores indicate less mindfulness (worse).

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

  7. Exploratory clinical symptoms outcome: The Valuing Questionnaire (VQ)

    The VQ is a 10-item self-report measure that was developed to assess changes in a target of ACT-valued living. Its' 2 subscales are correlated strongly with measures of emotional/affective symptoms and life satisfaction. In scoring, higher scores on the Progress scale are associated with health, as are lower scores on the Obstruction scale.

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

  8. Exploratory clinical symptoms outcome: The Emotion Regulation Questionnaire (ERQ).

    The ERQ is a 10-item self-report measure designed to assess individuals' tendency to regulate their emotions through Cognitive Reappraisal and Expressive Suppression. Emotion regulation is a target in ACT therapy. To score the ERQ, the average of the scores in each subscale - (i) cognitive reappraisal and (ii) expressive suppression are taken. The higher the score, the greater the use of that particular emotion regulation strategy - cognitive reappraisal is considered adaptive (thus higher scores are better) and expressive suppression maladaptive (lower scores are better).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start1 Dec 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
open label pilot feasibility study
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06462391
Sponsor's protocol ID
WCH-24-001
Acronym
ACT-PM
Status last verified
Dec 2025
First submitted
16 May 2024
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) Group in people with Premenstrual Dysphoric Disorder and Premenstrual Exacerbation of Mood Disorder, run by Women's College Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of recruitment and enrollment: number of participants referred (time frame: Screening and baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06462391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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