Wellness Intervention for Menstrual Mood Disorders (WIMM)
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|ClinicalTrials.gov Identifier: NCT01995916|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Menstrual Mood Disorders||Behavioral: Mindfulness Intervention Behavioral: Social Support Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms|
|Actual Study Start Date :||August 28, 2013|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||May 31, 2018|
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.
- 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
- 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
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
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Susan Girdler, PhD||UNC- Chapel Hill|