Wellness Intervention for Menstrual Mood Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-28

Study Completion Date

2018-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Menstrual Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mindfulness Intervention

Mindfulness Based Stress Reduction Intervention

Group Type EXPERIMENTAL

Mindfulness Intervention

Intervention Type BEHAVIORAL

The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.

Social Support Group

Social Support Group Intervention

Group Type ACTIVE_COMPARATOR

Social Support Group

Intervention Type BEHAVIORAL

The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.

Interventions

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Mindfulness Intervention

The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No