search
Back to results

Wellness Intervention for Menstrual Mood Disorders (WIMM)

Primary Purpose

Menstrual Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Intervention
Social Support Group
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Mood Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • UNC Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Intervention

Social Support Group

Arm Description

Mindfulness Based Stress Reduction Intervention

Social Support Group Intervention

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Change in premenstrual anxiety, irritability and total symptom severity
Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs).
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

Full Information

First Posted
November 7, 2013
Last Updated
November 16, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01995916
Brief Title
Wellness Intervention for Menstrual Mood Disorders
Acronym
WIMM
Official Title
Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 28, 2013 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Mood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Intervention
Arm Type
Experimental
Arm Description
Mindfulness Based Stress Reduction Intervention
Arm Title
Social Support Group
Arm Type
Active Comparator
Arm Description
Social Support Group Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention
Intervention Description
The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Intervention Type
Behavioral
Intervention Name(s)
Social Support Group
Intervention Description
The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Primary Outcome Measure Information:
Title
Change in Premenstrual Depression Symptomatology and Functional Impairment
Description
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.
Time Frame
Baseline, 8 weeks intervention, 6 months follow up
Title
Change in Cold Pain Sensitivity
Description
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
Time Frame
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 Measure Information:
Title
Change in premenstrual anxiety, irritability and total symptom severity
Description
Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs).
Time Frame
Baseline, 8 weeks intervention, 6 months follow up
Title
Change in sensitivity to the temporal summation of heat pain test
Description
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
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Girdler, PhD
Organizational Affiliation
UNC- Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33259351
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.
Results Reference
derived
Links:
URL
http://womensmooddisorders.org
Description
Study Information

Learn more about this trial

Wellness Intervention for Menstrual Mood Disorders

We'll reach out to this number within 24 hrs