Wellness Intervention for Menstrual Mood Disorders

Not Applicable

Completed

• Conditions: Menstrual Mood Disorders
• Interventions: Behavioral: Mindfulness Intervention; Behavioral: Social Support Group

• Registration Number: NCT01995916
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-28
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Intervention	Mindfulness Intervention	Mindfulness Based Stress Reduction Intervention
Social Support Group	Social Support Group	Social Support Group Intervention

Primary Outcome Measures

Name	Time	Method
Change in Premenstrual Depression Symptomatology and Functional Impairment	Baseline, 8 weeks intervention, 6 months follow up	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.
Change in Cold Pain Sensitivity	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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States