Enriched Environments in Endometriosis
Condition: Endometriosis-related Pain; Endometriosis; Pelvic Pain; Quality of Life; Inflammation Pelvic
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Endometriosis; Inflammation; Pelvic Pain
Study type: Interventional

Summary: 
      The investigators propose to conduct a randomized behavioral trial that will produce a
      clinically useful multi-level integrative medicine model to be used in stress- and
      inflammation-related disorders that can easily be implemented with current pharmacological
      interventions to alleviate pain and improve QoL.
    

Detailed description: 
      Endometriosis is a chronic inflammatory and painful condition that affects 176 million women
      in their reproductive years worldwide, and has substantial costs related to health care and
      loss in work productivity. The symptoms of endometriosis-chronic, incapacitating pain and
      infertility-cause high levels of stress, leading to poor quality of life (QoL) in affected
      women. Stress is known to affect the physiology of pelvic organs and to disturb the
      hypothalamic-pituitary-adrenal (HPA) axis leading to chronic, painful, inflammatory
      disorders. The team has documented a relationship between stress, HPA dysregulation and
      endometriosis. In an animal model the team demonstrated that stress exacerbates disease
      manifestations whereas the ability to control the level of stress results in smaller lesions
      and less inflammation. Further, the team has identified social support as one of the
      parameters that most significantly impacts QoL in women with endometriosis. Environmental
      enrichment (EE) can produce beneficial effects in models of chronic diseases improving
      anxiety and immune-related disturbances, and can block the effects of chronic stress on brain
      hippocampal integrity. The team recently found that EE can effectively minimize lesion size
      and numbers, and also decreased anxiety in this animal model. Together, these data support
      the basic premise of this proposal: EE interventions can overcome chronic stress thus
      reversing the negative influences on mental health status (depression/anxiety levels),
      inflammation/HPA axis (inflammatory cytokines, cortisol), and clinical course (pain levels)
      of endometriosis, leading to improved QoL. The central objective of this study is to refine
      and test a multi-modal intervention based on the EE paradigm tested in our animal model and
      translated it to the human scenario, to produce data on its effectiveness. The team
      hypothesizes that the EE interventions can be effectively adapted for women with
      endometriosis resulting in pain reduction and improved QoL. To test our hypothesis, our
      multidisciplinary team with combined expertise in endometriosis, psychology, physiology,
      neuroscience, gynecology, and stress management has adapted the experimental EE model to the
      human scenario. By applying a combined approach (systematic review of the literature, and
      input from a patient advisory committee) the team has developed six EE modules to be tested
      in human subjects. This study consists of two specific aims. In aim 1, the team will assess
      feasibility and acceptability of the EE interventions through a collaborative approach
      involving a patient population to refine EE modules. Under aim 2, the team will conduct a
      randomized clinical trial (RCT) of the EE intervention to determine its efficacy in
      improvement of pelvic pain and QoL (primary outcomes), and inflammation, HPA axis
      disturbances, and mental health (depression, anxiety) (secondary outcomes), measured before
      and after the intervention. With this purpose, the team will use a case control study design
      for the RCT where cases will receive the intervention as an adjuvant to standard gynecologic
      care for endometriosis, while controls will receive standard of care only. The proposed work
      will produce a clinically useful multi-level integrative medicine model to be used in stress-
      and inflammation-related disorders that can easily be implemented with current
      pharmacological interventions to alleviate pain and improve QoL.
    

Intervention name(s): Environmental enrichment
Intervention type(s): Behavioral
Intervention description(s): The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this RCT study, subjects randomized to the intervention condition will receive the EE intervention as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period in addition to an online patient training webinar.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: endometriosis; chronic pelvic pain; quality of life; inflammation; stress