Wellness Intervention for Menstrual Mood Disorders (WIMM)

Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms

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 Overview

• Status: Completed
• Conditions: Menstrual Mood Disorders
• Intervention / Treatment: Behavioral: Mindfulness Intervention; Behavioral: Social Support Group

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Intervention; Mindfulness Based Stress Reduction Intervention	Behavioral: Mindfulness Intervention; The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Active Comparator: Social Support Group; Social Support Group Intervention	Behavioral: Social Support Group; The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in premenstrual anxiety, irritability and total symptom severity	Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs).	Baseline, 8 weeks intervention, 6 months follow up
Change in sensitivity to the temporal summation of heat pain test	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	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Susan Girdler, PhD, UNC- Chapel Hill

Publications and helpful links

General Publications

• Andersen E, Geiger P, Schiller C, Bluth K, Watkins L, Zhang Y, Xia K, Tauseef H, Leserman J, Girdler S, Gaylord S. Effects of Mindfulness-Based Stress Reduction on Experimental Pain Sensitivity and Cortisol Responses in Women With Early Life Abuse: A Randomized Controlled Trial. Psychosom Med. 2021 Jul-Aug 01;83(6):515-527. doi: 10.1097/PSY.0000000000000889.

Helpful Links

• Study Information

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2013
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: 13-1867; 1R01MH099076-01A1 (U.S. NIH Grant/Contract)