Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms: An Open-label Feasibility Study of ACT-PM
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Feasibility of recruitment and enrollment: number of participants referred
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(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).
排除标准
- •(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.
结局指标
主要结局
Feasibility of recruitment and enrollment: number of participants referred
时间窗: Screening and baseline
Tracking to see how many referrals are made to the study
Feasibility of recruitment and enrollment to study: number of participants enrolled
时间窗: Screening and baseline
Tracking number of participants that enrolled into the study
Adoption outcome: group attendance
时间窗: During intervention, post-intervention (after 8 weeks of intervention)
Tracking group attendance per session
Adoption outcome: group completion
时间窗: During intervention, post-intervention (after 8 weeks of intervention)
Tracking how many participants completed the group
Adoption outcome: reasons for non-completion
时间窗: During intervention, post-intervention (after 8 weeks of intervention)
Tracking the reasons why participants did not complete the group
Feasibility of recruitment and enrollment to study: reasons for non-participation
时间窗: Screening and baseline
Tracking number of participants who did not enroll into the study and any reasons given by these participants
Feasibility of recruitment and enrollment: number of participants eligible
时间窗: Screening and baseline
Tracking number of participants that were eligible out of the number that was referred
Acceptability outcome
时间窗: Post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Determining the acceptability of the program among participants and facilitators via questionnaires about their experience in the program.
Adherence with intervention protocol: therapist adherence
时间窗: During and post-intervention (after 8 weeks of intervention)
(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)
Adherence with intervention protocol: completion of participant questionnaires
时间窗: Baseline, during intervention, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Tracking number of participants who completed data collection measures (i.e.. acceptability questionnaire, and clinical scales - described below)
次要结局
- 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: 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: 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 Emotion Regulation Questionnaire (ERQ).(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)
- Exploratory clinical symptoms outcome: The Mindfulness Attention Awareness Scale (MAAS)(Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up)
- Exploratory clinical symptoms outcome: The Valuing Questionnaire (VQ)(Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up)
研究者
Elisabeth Wright
Psychiatrist, Principal Investigator
Women's College Hospital