- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01995916
Wellness Intervention for Menstrual Mood Disorders (WIMM)
November 16, 2018 updated by: University of North Carolina, Chapel Hill
Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Chapel Hill
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness Intervention
Mindfulness Based Stress Reduction Intervention
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The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
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Active Comparator: Social Support Group
Social Support Group Intervention
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The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 8 weeks intervention, 6 months follow up
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, 8 weeks intervention, 6 months follow up
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Susan Girdler, PhD, UNC- Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2013
Primary Completion (Actual)
May 31, 2018
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
November 7, 2013
First Submitted That Met QC Criteria
November 21, 2013
First Posted (Estimate)
November 27, 2013
Study Record Updates
Last Update Posted (Actual)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 16, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-1867
- 1R01MH099076-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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