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Wellness Intervention for Menstrual Mood Disorders (WIMM)

This study is currently recruiting participants.
Verified September 2017 by Susan Girdler, PhD, University of North Carolina, Chapel Hill
Sponsor:
ClinicalTrials.gov Identifier:
NCT01995916
First Posted: November 27, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Girdler, PhD, University of North Carolina, Chapel Hill
  Purpose
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 Intervention
Menstrual Mood Disorders Behavioral: Mindfulness Intervention Behavioral: Social Support Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms

Resource links provided by NLM:


Further study details as provided by Susan Girdler, PhD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in Premenstrual Depression Symptomatology and Functional Impairment [ Time Frame: 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 [ 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 ]
    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 [ Time Frame: 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 [ 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 ]
    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


Estimated Enrollment: 140
Study Start Date: August 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995916


Contacts
Contact: Markeela Lipscomb 919-972-7440 markeela_lipscomb@med.unc.edu

Locations
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Markeela Lipscomb    919-972-7440    markeela_lipscomb@med.unc.edu   
Principal Investigator: Susan Girdler, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan Girdler, PhD UNC- Chapel Hill
  More Information

Additional Information:
Responsible Party: Susan Girdler, PhD, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01995916     History of Changes
Other Study ID Numbers: 13-1867
1R01MH099076-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 7, 2013
First Posted: November 27, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Disease
Mood Disorders
Pathologic Processes
Mental Disorders