Menstrual Mood Disorders Clinical Trial
— WIMMOfficial title:
Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
| Verified date | November 2018 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | May 31, 2018 |
| Est. primary completion date | May 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | UNC Chapel Hill | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Premenstrual Depression Symptomatology and Functional Impairment | 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. | Baseline, 8 weeks intervention, 6 months follow up | |
| Primary | Change in Cold Pain Sensitivity | 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 | 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 | |
| Secondary | Change in premenstrual anxiety, irritability and total symptom severity | Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs). | Baseline, 8 weeks intervention, 6 months follow up | |
| Secondary | Change in sensitivity to the temporal summation of heat pain test | Sensitivity to a temporal summation of heat pain test will be assessed in a laboratory setting before and after the intervention, and again 3 and 6 months later | 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 |