Menstrual Mood DisordersWIMMNCT01995916
Wellness Intervention for Menstrual Mood Disorders
A study testing Mindfulness Intervention and Social Support Group in people with Menstrual Mood Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Menstrual Mood Disorders
- What is being tested?
- Mindfulness Intervention and Social Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2013to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- Absence of current PTSD symptoms using the 17-item PTSD checklist (PCL)
- 8th grade literacy level
- Ability to give informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Menstrual Mood Disorders
- Being tested
- Mindfulness Intervention, Social Support Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Social Support GroupBehavioural
The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | Mindfulness Based Stress Reduction Intervention Receives: Behavioral: Mindfulness Intervention |
| Social Support Group | Active comparator | Social Support Group Intervention Receives: Behavioral: Social Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Secondary outcomes (2)
Change in premenstrual anxiety, irritability and total symptom severity
Symptoms will be assessed prospectively through Daily Record of Severity of Problems (DRSPs).
Measured: Baseline, 8 weeks intervention, 6 months follow up
Change in sensitivity to the temporal summation of heat pain test
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study start28 Aug 2013
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual Mood DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Susan Girdler, PhD, Principal investigator, UNC- Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995916
- Sponsor's protocol ID
- 13-1867
- Other IDs
- 1R01MH099076-01A1
- Acronym
- WIMM
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2013
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33259351
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms
- ClinicalTrials.gov ID
- NCT01995916
- Acronym / sponsor ID
- WIMM / 13-1867
- Conditions
- Menstrual Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Aug 2013 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness InterventionMindfulness Based Stress Reduction Intervention |
| Social Support Group | Active comparator | Behavioral: Social Support GroupSocial Support Group Intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness InterventionThe Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat. | Behavioural | Mindfulness Intervention |
| Social Support GroupThe Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat. | Behavioural | Social Support Group |
Primary outcome
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
2 secondary outcomes
Change in premenstrual anxiety, irritability and total symptom severity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 33259351Andersen 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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The SPARK-PMDD Study
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To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
Premenstrual Dysphoric Disorder ( PMDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Girdler, PhD principal investigator
UNC- Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention and Social Support Group in people with Menstrual Mood Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Premenstrual Depression Symptomatology and Functional Impairment (time frame: Baseline, 8 weeks intervention, 6 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.