CompletedNot Applicable

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 range18 Years – 55 Years

SexFEMALE

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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

What they're measuring

Change in Premenstrual Depression Symptomatology and Functional Impairment

Timeframe: Baseline, 8 weeks intervention, 6 months follow up

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

Trial details

NCT IDNCT01995916

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-31

View on ClinicalTrials.gov More Menstrual Mood Disorders trials