Wellness Intervention for Menstrual Mood Disorders

Completed · Not applicable

Conditions studied: Menstrual Mood Disorders

In brief

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.

Key facts

Study ID

NCT01995916

Run by

University of North Carolina, Chapel Hill

People needed

300

Starts

2013-08-28

Expected to finish

2018-05-31

Last updated by the study team

2018-11-20

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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