Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment
研究概览
简要总结
Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed.
Preliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).
详细描述
The study is a parallel two-group RCT with 1:1 allocation to 8 weeks of a therapist-guided self-help ICBT for PMDD or a waitlist control group. Approximately 164 women (age 18-45) fulfilling the DSM-5 diagnostic criteria for PMDD will be randomly assigned.
Recruitment
Participants will be recruited from the general population using the following screening procedure.
- Web-based screening for PMDD (Premenstrual Screening Tool) and other eligibility criteria
- Clinical diagnostic (telephone) interview assessing preliminary PMDD diagnosis and psychiatric comorbidity
- Prospective daily ratings of premenstrual symptoms during two consecutive menstrual cycles using the Daily Report of Severity of Problems (DRSP).
Outcomes and Expected Results
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomisation will be performed externally by a person independent from the study. After group allocation, participants in the TG will be randomly assigned to one of the therapists involved in the trial. A statistician blinded to group allocation will conduct all statistical analyses.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PMDD diagnosis according to DSM-5
- •Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months
- •Sufficient proficiency in Swedish to comprehend the treatment materials
- •Access to computer/tablet/mobile phone with internet connection
排除标准
- •Breastfeeding or pregnancy during the previous three months
- •Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months
- •Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results
- •Ongoing or previous psychological treatment for premenstrual disorders
- •Severe mental disorders that may interfere with the person's ability to complete the treatment or complicate the interpretation of results, e.g., psychosis, bipolar disorder, severe eating disorder, or severe depression
- •Elevated suicide risk (e.g., recurrent active suicidal ideation, current suicide plans, previous suicide attempts).
结局指标
主要结局
Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment
时间窗: Baseline to post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).
This primary outcome is assessed with the Daily Report of Severity of Problems. (DRSP) The DRSP assesses premenstrual symptoms included in DSM-5 diagnostic criteria for PMDD and their impact on everyday life. Items are rated on a scale from 1-6. Baseline and post-treatment data consist of prospective daily DRSP ratings over two consecutive menstrual cycles, both before and after treatment. Follow-up assessments will include daily DRSP ratings over one menstrual cycle.
Group differences in PMDD-related psychological and functional impairment during the luteal phase from baseline to post-treatment
时间窗: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
This outcome is assessed using the PMS Impact Questionnaire (PMS-I) which includes two subscales: (1) psychological impairment and (2) functional impairment. The PMS-I consists of 18 items (9 for each subscale) rated on a scale from 1-4 scale (max score 72, higher points indicating higher levels of psychological and functional impairment).
次要结局
- Group differences in quality of life during the luteal phase from baseline to post-treatment(Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.)
- Group differences in difficulties in emotion regulation during the luteal phase from baseline to post-treatment.(Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.)
- Group differences in health-related quality of life during the luteal phase from baseline to post-treatment(Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.)
- Remission (Full/Partial)(Post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).)