A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility (as determined by attrition rate)
研究概览
简要总结
The purpose of this study is to test the feasibility and efficacy of a brief group therapy treatment program focused on reducing pain catastrophizing in adolescents and young adults (ages 16-25) with menstrual pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ages 16-25 years
- •Self-reported menstrual cycle averaging 24-32 days
- •Menstrual pain rating of ≥4 on the Numeric Rating Scale for at least the previous three menstrual cycles prior to participation
- •Written informed consent or assent (if a minor, parent must also provide written parental permission)
- •Able to read and understand English
排除标准
- •Use of oral contraceptives or any exogenous hormones in the previous 3 months
- •Presence of persistent pelvic pain throughout the menstrual cycle
- •Acute illness or injury that may impact lab performance or that affects sensitivity of the extremities
- •Diagnosis of an underlying medical cause for dysmenorrhea symptoms
- •No or minimal menstrual pain (NRS rating of ≤ 3) during any of the 3 previous cycles prior to study participation
- •Daily use of opioids; participants using other analgesics will be included, but will be asked not to take these analgesics on the days of the lab sessions
- •Developmental delay, autism, or significant anatomic impairment that may preclude understanding of study procedures
研究组 & 干预措施
Cognitive behavioral therapy
Cognitive behavioral therapy aimed at reducing pain catastrophizing.
干预措施: Cognitive behavioral therapy (Behavioral)
结局指标
主要结局
Feasibility (as determined by attrition rate)
时间窗: After each cohort completes their 5 group CBT sessions; 1 week after the 5th and final CBT session in each cohort
Change in menstrual pain level assessed via 11-point numeric rating scale (NRS)
时间窗: Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion
Change in medication use (dosage and frequency of pain medication use)
时间窗: Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion
Acceptability - participants' views of the intervention's 1) appeal; 2) helpfulness; and 3) ease of participation
时间窗: Assessed via qualitative interviews which will occur during each participant's post-intervention lab assessment (i.e., during the first two days of the first menstrual period after intervention completion)
Change in pain catastrophizing
时间窗: Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion
次要结局
- Change in menstrual symptoms as assessed by the Menstrual Symptom Questionnaire (MSQ)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
- Change in anxiety as assessed by the Brief Symptom Inventory 18 (BSI-18)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
- Change in depression as assessed by the Brief Symptom Inventory 18 (BSI-18)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
- Change in temporal summation (TS)(Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation)
- Change in conditioned pain modulation (CPM): pain ratings in response to a heat stimulus prior to and after administration of a conditioning pain stimulus (cold water)(Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation)
- Change in somatization as assessed by the Brief Symptom Inventory 18 (BSI-18)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
研究者
Laura Payne
Adjunct Assistant Professor
University of California, Los Angeles