Clinical trial NCT04179149: Enriched Environments in Endometriosis
Official title: Enriched Environments: a Multi-level Integrative Medicine Intervention for Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis-related Pain
Endometriosis
Pelvic Pain
Quality of Life
Inflammation Pelvic
Keywords: endometriosis
chronic pelvic pain
quality of life
inflammation
stress
Lead sponsor: Ponce Medical School Foundation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
name: DHR Health Institute for Research and Development
First posted: 2019-11-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this RCT study, subjects randomized to the intervention condition will receive the Environmental Enrichment (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 online seminar.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain Perception
timeFrame: at baseline, at end of the intervention and 3 months after the end of intervention
measure: Quality of Life (QoL)
timeFrame: at baseline, at end of the intervention and 3 months after the end of intervention (for intervention); at baseline and end of intervention (for controls)
Secondary outcomes:
measure: Perceived Stress Levels 14
timeFrame: at baseline, at end of the intervention and 3 months after the end of intervention (for the intervention); at baseline and end of the intervention (for controls)
measure: Depressive Symptomatology
timeFrame: at baseline, at end of the intervention and 3 months after the end of intervention; and at baseline and post-intervention for the control group.
measure: Anxiety Symptomatology
timeFrame: at baseline, at end of the intervention and 3 months after the end of intervention (for the intervention group) and at baseline and end of the intervention (for the control group)
Other outcomes:
Locations:
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation
Study officials:
affiliation: Ponce Medical School Foundation
name: Idhaliz Flores, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieves-Vazquez CI, Detres-Marquez AC, Torres-Reveron A, Appleyard CB, Llorens-De Jesus AP, Resto IN, Lopez-Rodriguez V, Ramos-Echevarria PM, Castro EM, Flores I. Feasibility and acceptability of an adapted environmental enrichment intervention for endometriosis: A pilot study. Front Glob Womens Health. 2023 Jan 4;3:1058559. doi: 10.3389/fgwh.2022.1058559. eCollection 2022.
citation: De Hoyos G, Ramos-Sostre D, Torres-Reveron A, Barros-Cartagena B, Lopez-Rodriguez V, Nieves-Vazquez C, Santiago-Saavedra F, Appleyard CB, Castro EM, Flores I. Efficacy of an environmental enrichment intervention for endometriosis: a pilot study. Front Psychol. 2023 Oct 10;14:1225790. doi: 10.3389/fpsyg.2023.1225790. eCollection 2023.