Clinical trial NCT06462391: Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms
Official title: Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms: An Open-label Feasibility Study of ACT-PM
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premenstrual Dysphoric Disorder
Premenstrual Exacerbation of Mood Disorder
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label pilot feasibility study
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment and enrollment: number of participants referred
timeFrame: Screening and baseline
measure: Feasibility of recruitment and enrollment: number of participants eligible
timeFrame: Screening and baseline
measure: Feasibility of recruitment and enrollment to study: number of participants enrolled
timeFrame: Screening and baseline
measure: Feasibility of recruitment and enrollment to study: reasons for non-participation
timeFrame: Screening and baseline
measure: Adoption outcome: group attendance
timeFrame: During intervention, post-intervention (after 8 weeks of intervention)
measure: Adoption outcome: group completion
timeFrame: During intervention, post-intervention (after 8 weeks of intervention)
measure: Adoption outcome: reasons for non-completion
timeFrame: During intervention, post-intervention (after 8 weeks of intervention)
measure: Acceptability outcome
timeFrame: Post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Adherence with intervention protocol: therapist adherence
timeFrame: During and post-intervention (after 8 weeks of intervention)
measure: Adherence with intervention protocol: completion of participant questionnaires
timeFrame: Baseline, during intervention, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Secondary outcomes:
measure: Exploratory clinical symptoms outcome: McMaster Premenstrual And Mood Symptom Scale (MAC PMSS)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: Premenstrual Symptoms Screening Tool (PSST)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: The Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: The Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: The Mindfulness Attention Awareness Scale (MAAS)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: The Valuing Questionnaire (VQ)
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
measure: Exploratory clinical symptoms outcome: The Emotion Regulation Questionnaire (ERQ).
timeFrame: Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Other outcomes:
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