Wellness Intervention for Menstrual Mood Disorders

N/ACompletedNCT01995916

University of North Carolina, Chapel Hill300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Menstrual Mood Disorders

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 8 weeks intervention, 6 months follow up

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

Time frame: 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 Outcomes

Change in premenstrual anxiety, irritability and total symptom severity

Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs).