Wellness Intervention for Menstrual Mood Disorders

NCT01995916 | Completed DMC

• 2 other identifiers: 13-18671R01MH099076-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Mood Disorders

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in premenstrual anxiety, irritability and total symptom severity

  Baseline, 8 weeks intervention, 6 months follow up

• Change in sensitivity to the temporal summation of heat pain test

  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

Study Arms (2)

Mindfulness Intervention

EXPERIMENTAL

Mindfulness Based Stress Reduction Intervention

Behavioral: Mindfulness Intervention

Social Support Group

ACTIVE COMPARATOR

Social Support Group Intervention

Behavioral: Social Support Group

Interventions

Mindfulness Intervention BEHAVIORAL

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

Mindfulness Intervention

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.

Social Support Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)
• th grade literacy level
• Ability to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 33259351 DERIVED

MeSH Terms

Interventions

Self-Help Groups

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Susan Girdler, PhD

  UNC- Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 27, 2013
• Study Start: August 28, 2013
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

US (1)