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WIMM: Wellness Intervention for Menstrual Mood Disorders

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT01995916
Collaborator
National Institute of Mental Health (NIMH) (NIH)
300
Enrollment
1
Location
2
Arms
57.1
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Intervention
  • Behavioral: Social Support Group
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
Actual Study Start Date :
Aug 28, 2013
Actual Primary Completion Date :
May 31, 2018
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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).

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UNC Chapel Hill Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Susan Girdler, PhD, UNC- Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01995916
Other Study ID Numbers:
  • 13-1867
  • 1R01MH099076-01A1
First Posted:
Nov 27, 2013
Last Update Posted:
Nov 20, 2018
Last Verified:
Nov 1, 2018
Additional relevant MeSH terms:
Mood Disorders

Study Results

No Results Posted as of Nov 20, 2018