Enriched Environments in Endometriosis

Quality of Life Clinical Trial

Official title:

Enriched Environments: a Multi-level Integrative Medicine Intervention for Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179149
• Other study ID #: 1R21HD098481-01
• Status: Completed
• Phase: N/A
• Start date: September 13, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2022
• Source: Ponce Medical School Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• premenopausal adult women
• adults 18 and 49 y/o
• diagnosed with endometriosis by surgery
• symptomatic
• refractory to hormonal treatment
• able to provide written informed consent

Exclusion Criteria:

• Pregnant women (or who become pregnant during the study period)
• Asymptomatic
• Documented visual, cognitive or physical impairment that would interfere with participation or consent.
• Currently under mental health pharmacological treatment
• Currently using steroid medications.
• Diagnosis of pain syndromes (e.g., fibromyalgia, chronic fatigue syndrome).

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis-related Pain
• Inflammation
• Inflammation Pelvic
• Pelvic Inflammatory Disease
• Pelvic Pain
• Quality of Life

Intervention

Behavioral:
• Environmental enrichment
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

Locations

Country	Name	City	State
Puerto Rico	Ponce Medical School Foundation	Ponce

Sponsors (3)

Lead Sponsor	Collaborator
Ponce Medical School Foundation, Inc.	DHR Health Institute for Research and Development, University of Oxford

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain perception	=15% change in pain scores, from baseline, using the Visual Analog Scale (VAS), in which 1 is no pain and 10 is the worst pain imaginable.	6 months (3 months from the end of intervention)
Primary	quality of life (QoL)	=20% change in QoL scores from baseline value; scores measured using the Endometriosis Health Profile 30 (EHP-30), a disease-specific questionnaire to measure health related quality of life. The EHP-30 was developed by Jones et al., in 2001. Part 1 The first part contains 30 questions relevant to all women with endometriosis covering five areas: pain, emotional well-being, control and powerlessness, social support and self imaging scales. Part 2 contains 23 questions covering areas such as work, relationship with children, sexual activity, infertility, medical profession and treatment, which are not necessarily relevant to all women with endometriosis. The score of each domain ranges from 0 (indicating the best health status) to 100 (indicating the worst health status). The score of each domain was calculated by dividing the total of the raw scores of each item in the domain by the maximum possible raw score of all items in the domain multiplied by 100.	6 months (3 months from the end of intervention)
Secondary	stress	Saliva samples for cortisol levels will be obtained at the beginning and end of interventions 1, 4 and 6, and 3 months from the end of intervention	6 months (3 months from the end of intervention)
Secondary	inflammatory cytokines	serum inflammatory cytokine levels (e.g., interleukins 1, 6, 8, tumor necrosis factor, interferons) will be assessed at baseline, 3 months, 6 months and 3 months from the end of intervention using multi-analyte profiling	6 months (3 months from the end of intervention)
Secondary	depression	Beck's Depression Index assessed at baseline, 3 months, 6 months and 3 months from the end of intervention	6 months (3 months from the end of intervention)
Secondary	anxiety	Beck's Anxiety Index assessed at baseline, 3 months, 6 months and 3 months from the end of intervention	6 months (3 months from the end of intervention)