Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms
NCT Number: NCT06462391
Acronym: ACT-PM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premenstrual Dysphoric Disorder|Premenstrual Exacerbation of Mood Disorder
Interventions: BEHAVIORAL: Acceptance and Commitment Therapy (ACT) Group
Sponsor: Women's College Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2026-12-31

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.

Primary Outcome Measures: 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 Outcome Measures: 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., Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up|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., 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), 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., 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), 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., 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), 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., Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up|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)., Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up|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., Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up|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)., Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up