Wellness Intervention for Menstrual Mood Disorders
United States300 participantsStarted 2013-08-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* Diabetes
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Premenstrual Depression Symptomatology and Functional Impairment
Timeframe: Baseline, 8 weeks intervention, 6 months follow up
2
Change in Cold Pain Sensitivity
Timeframe: 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