Efficacy of an environmental enrichment intervention for endometriosis: a pilot study

Abstract

Introduction: We have previously shown that Environmental Enrichment (EE), a multi-modal psychosocial intervention consisting of increased social interaction, novelty, and open spaces, improved disease presentation, anxiety, and immune-related disturbances in the rat model of endometriosis. However, there is a knowledge gap regarding the effects of EE interventions in patients with this painful, inflammatory chronic disease.

Aim: To adapt and test the efficacy of an EE intervention on pelvic pain, mental health, perceived stress, quality of life, and systemic inflammation in endometriosis patients through a randomized clinical trial (RCT).

Materials and methods: A multidisciplinary team with expertise in physiology, neuroscience, psychology, and women's health adapted and implemented a two-arm RCT comparing an EE intervention with a wait-list control group. Six EE modules administered on alternate weeks were provided to patients in the intervention (N = 29); controls received education only. Survey data and biospecimens were collected at baseline, end-of-study, and 3-months post-intervention to assess pain (Brief Pain Inventory, BPI), endometriosis-related quality of life-QoL (Endometriosis Health Profile-30, EHP30), anxiety (Generalized Anxiety Disorder 7, GAD7), depression (Patient Health Questionnaire for Depression 8, PHQ8), pain catastrophizing (Pain Catastrophizing Score, PCS), stress (Perceived Stress Scale-14, PSS14), and saliva cortisol levels (AM, PM).

Results: Compared to the wait-list controls, participants in the EE intervention showed significantly decreased GAD-7 scores at the end of the intervention and 3-month follow-up. Depression, perceived stress, and QoL improved at the 3-month follow-up compared to baseline. While pain levels did not improve, they significantly correlated with anxiety, depression, QoL and pain catastrophizing scores.

Conclusion: This pilot RCT demonstrated significant improvements in anxiety and depressive symptoms, QoL, and perceived stress, supporting enriched environments as an integrative psychosocial intervention to be used as adjuvant to the standard of care for endometriosis pain.

Keywords: anxiety; depression; endometriosis; environmental enrichment; pelvic pain; quality of life; randomized clinical trial; stress.

Figure 1

Clinical profile of study participants. Participants completed the EPhect Clinical Questionnaire at baseline. Demographic and clinical variables were self reported. CPP = chronic pelvic pain, MS = musculoesqueletal pain.

Figure 2

Pain levels and impact of pain (BPI). (A) Global impact of endometriosis pain was measured by the BPI survey at baseline, end and follow up (for intervention group). No significant differences were observed between end and baseline in neither group. (B) Impact of individual BPI domains were also not significantly different at the end of the intervention in neither group.

Figure 3

Change in pain levels. Change in pain levels was measured using the BPI survey's NRS scale, that assesses pain intensity at its Minimum (A), Maximum (B), Average (C), and Current (D). NRS scale: 0 = no pain; 10 = worst imaginable pain. This survey was completed at baseline and end of the intervention.

Figure 4

GAD-7 and PHQ-8 scores. Participants completed the GAD-7 and PHQ-8 at baseline end and 3-month follow up. Control group completed these questionnaires at baseline and end of the intervention period. A score of 15 or more is clinically significant.

Figure 5

PHQ-8 and GAD-7 scores correlations.

Figure 6

Endometriosis related quality of life (EHP-30). Participants completed the EHP-30 at baseline end and 3-month follow up. Control group completed these questionnaires at baseline and end of the intervention period.

Figure 7

EHP-30 global impact score and pain correlations.

Figure 8

PCS scores and correlations. Participants completed the PCS instrument at baseline. A score of 30 or more is clinically significant.

Figure 9

Perceived stress score (PSS-14). Participants completed the PSS-14 at baseline end and 3-month follow up. Control group completed this questionnaire at baseline and end of the intervention period. A score of 38 or more indicates high stress.

Figure 10

Stress reactivity (salivary cortisol). Participants donated saliva samples at baseline, end and 3-month follow up. Control group donated samples at baseline and end of the intervention period. Samples were collected at ~8 am and at ~12pm by passive drooling. Cortisol levels were analyzed by ELISA, and % PM-AM change were calculated.