Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in Premenstrual Depression Symptomatology and Functional Impairment
研究概览
简要总结
This study has been funded by National Institute of Mental Health (NIMH) to compare two behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric disorder (PMDD). Both of these interventions will be run in a group format, meaning that you will be part of a group of other women who have a menstrual mood disorder. Both of these interventions will be run by experienced mental health professionals and both interventions have been shown to be effective in reducing mood symptoms, increasing a sense of well-being, and helping individuals cope with stress. While it is expected that both interventions to be associated with some benefit, this study is designed to see which is better for women with a menstrual mood disorder.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meets prospective criteria for a menstrual mood disorder, including PMDD
- •Depression symptom severity and functional impairment based on prospective symptom ratings for 2-3 cycles using the Daily Record of Severity of Problems (DRSP)
- •Clear remission of all symptoms during days 6-10
- •18 - 55 years of age
- •Regular menstrual cycles
- •Early life sexual or physical abuse (50% of sample) or no history of sexual or physical abuse (50% of sample)
- •Absence of current PTSD symptoms using the 17-item PTSD checklist (PCL)
- •8th grade literacy level
- •Ability to give informed consent
排除标准
- •Current Axis I disorder or suicide ideation (histories of depression, anxiety, substance abuse, and eating disorders are allowed if in remission for >2 years)
- •Premenstrual exacerbation of chronic disorders
- •In a current abusive relationship or residing with a former abuser
- •A lifetime history of suicide attempt, or suicidal thoughts or gestures within 5 years of study enrollment
- •Histories of bipolar or psychotic disorders
- •Age < 18 or > 55 years
- •Pregnancy or breastfeeding
- •Use of psychotropic, hormonal or other agents that alter mood or biological mediators
- •Current functional pain disorder
- •A history of meditation practice (2+ times/week for 15+ min; some yoga allowed)
- •BMI < 18.5
- •Vigorous exercise
- •Stage 2 Hypertension
- •Any symptom item rated >2 (moderate or higher) or a total score > 24 on the PTSD checklist
研究组 & 干预措施
Mindfulness Intervention
Mindfulness Based Stress Reduction Intervention
干预措施: Mindfulness Intervention (Behavioral)
Social Support Group
Social Support Group Intervention
干预措施: Social Support Group (Behavioral)
结局指标
主要结局
Change in Premenstrual Depression Symptomatology and Functional Impairment
时间窗: Baseline, 8 weeks intervention, 6 months follow up
Premenstrual depression symptoms will be assessed prospectively before, during and for 6 months after the intervention using Daily Record of Severity of Problems (DRSPs). Functional impairment will be assessed via questionnaire at baseline, at 2 week intervals throughout the intervention, and monthly during the follow-up phase.
Change in Cold Pain Sensitivity
时间窗: Lab 1 before the start of the intervention, Lab 2 immediately following intervention, Labs 3 and 4 during month 3 and 6 of follow up phase
Sensitivity to a cold pressor pain test (hand submerged in ice water) will be assessed in a laboratory setting before and after the intervention, and again 3 and 6 months later
次要结局
- Change in premenstrual anxiety, irritability and total symptom severity(Baseline, 8 weeks intervention, 6 months follow up)
- Change in sensitivity to the temporal summation of heat pain test(Lab 1 before the start of the intervention, Lab 2 immediately following intervention, Labs 3 and 4 during month 3 and 6 of follow up phase)