Clinical trial NCT01995916: Wellness Intervention for Menstrual Mood Disorders
Official title: Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Mood Disorders
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-11-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Premenstrual Depression Symptomatology and Functional Impairment
timeFrame: Baseline, 8 weeks intervention, 6 months follow up
measure: Change in Cold Pain Sensitivity
timeFrame: 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:
measure: Change in premenstrual anxiety, irritability and total symptom severity
timeFrame: Baseline, 8 weeks intervention, 6 months follow up
measure: Change in sensitivity to the temporal summation of heat pain test
timeFrame: 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
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC- Chapel Hill
name: Susan Girdler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.