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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH099076-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Intervention | Experimental | Mindfulness Based Stress Reduction Intervention |
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| Social Support Group | Active Comparator | Social Support Group Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Intervention | Behavioral | The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 8 weeks intervention, 6 months follow up |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in premenstrual anxiety, irritability and total symptom severity | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Girdler, PhD | UNC- Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33259351 | Derived | 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. |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Social Support Group | Behavioral | The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat. |
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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 |