Wellness Intervention for Menstrual Mood Disorders



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:11/22/2018
Start Date:August 28, 2013
End Date:May 31, 2018

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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.


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
We found this trial at
1
site
CHapel Hill, North Carolina 27599
Principal Investigator: Susan Girdler, PhD
Phone: 919-972-7440
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from
CHapel Hill, NC
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