Wellness Intervention for Menstrual Mood Disorders (WIMM)

University of North Carolina (UNC)

Status: Completed

Conditions: Menstrual Mood Disorders

Treatments: Behavioral: Social Support Group; Behavioral: Mindfulness Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01995916

13-1867

1R01MH099076-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Mindfulness Intervention

Experimental group

Description:

Mindfulness Based Stress Reduction Intervention

Treatment:

Behavioral: Mindfulness Intervention

Social Support Group

Active Comparator group

Description:

Social Support Group Intervention

Treatment:

Behavioral: Social Support Group