Menstrual Mood Disorders
Conditions
Brief 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.
Interventions
BEHAVIORALMindfulness Intervention
The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
BEHAVIORALSocial Support Group
The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Premenstrual Depression Symptomatology and Functional Impairment | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in premenstrual anxiety, irritability and total symptom severity | Baseline, 8 weeks intervention, 6 months follow up | Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs). |
| 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 | 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 |
Countries
United States
Outcome results
None listed