Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01995916 · ClinicalTrials.gov registry record · NA
Wellness Intervention for Menstrual Mood Disorders
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT01995916: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT01995916 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01995916, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Mindfulness Intervention
- BEHAVIORAL Social Support Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-08-28 |
| Est. Completion | 2018-05-31 |
| Phase | NA |
What the finished NCT01995916 record still lists
NCT01995916 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Intervention is the first listed.
NCT01995916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01995916 about?
NCT01995916 is a clinical study titled "Wellness Intervention for Menstrual Mood Disorders". 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 othe...
What is the current status of trial NCT01995916?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2013-08-28. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT01995916?
The interventions under investigation include: Mindfulness Intervention (BEHAVIORAL), Social Support Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT01995916?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01995916's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI