Telehealth cognitive behavioural therapy improves health-related quality of life and pain in endometriosis: the Healing Pelvic Pain Intervention (HaPPI)-a randomized controlled trial.

study questionIs telehealth cognitive behavioural therapy (CBT) or yoga effective in improving health-related quality of life (HRQoL) and secondary outcomes for endometriosis? SUMMARY ANSWER: Endometriosis-tailored CBT is superior to education for improving HRQoL and pain. WHAT IS KNOWN ALREADY: Endometriosis is a burdensome disease that contributes to diminished quality of life. Current biomedical care including hormonal and analgesic treatment is associated with inconsistent efficacy. Interdisciplinary care is therefore needed to augment the well-being of people with endometriosis. Although studies have suggested that CBT and yoga are promising for relieving pain and other symptoms associated with endometriosis, the evidence remains limited because they are based on small pilot studies. STUDY DESIGN SIZE DURATION: In this parallel 8-week randomized controlled trial (RCT), 334 participants were randomized using a computer-generated sequence with allocation concealment between April 2021 and February 2024. Outcome assessors were blinded to the group. PARTICIPANTS/MATERIALS SETTING

methodsParticipants required a diagnosis of endometriosis with pain for at least 6 months, and access to internet. Participants were randomly allocated to: (i) CBT (8-week telehealth therapist-led group, n = 79); (ii) yoga (8-week telehealth therapist-led group, n = 83); or (iii) education materials via email (n = 84). Primary outcomes: endometriosis-specific HRQoL (Endometriosis Health Profile-30; EHP-30 Total and Pain); general HRQoL (EQ-5D-5L global health) at post-treatment (8 weeks). Secondary outcomes: pain (period pain, bowel pain, bladder pain, and sexual pain), pain catastrophizing, pain self-efficacy, psychological distress, sleep, fatigue, menstrual symptoms, and central sensitization. Mixed-effects models examined group by time differences. MAIN RESULTS AND THE ROLE OF CHANCE: The CBT group reported statistically significant improvements in endometriosis-specific HRQoL (EHP Pain LIMITATIONS REASONS FOR CAUTION: Due to the presence of COVID-19 restrictions during data collection, CBT and yoga were delivered online. As a result, it is unclear whether CBT and yoga would have the same effects if delivered face-to-face, or whether online delivery would show comparable efficacy in a post-pandemic context. WIDER IMPLICATIONS OF THE

findingsOur RCT is the first to test the efficacy of telehealth CBT or yoga for improving outcomes in people living with endometriosis compared to an active control. Telehealth CBT demonstrated efficacy for improving endometriosis-specific and general HRQoL in people with endometriosis, as well as pain outcomes. Yoga demonstrated efficacy for improving menstrual symptoms and pain during sex. We recommend endometriosis-tailored CBT as part of interdisciplinary management for people with endometriosis, including online delivery to address access and mobility barriers. Yoga may be helpful in augmenting pelvic health. STUDY FUNDING/COMPETING INTERESTS: This work is supported by the Australian Government, Canberra under the Medical Research Future Fund grant number MRFF1200214. The authors do not have any conflicts of interest in relation to the present study. TRIAL REGISTRATION NUMBER: ACTRN12620000756921 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379947&isReview=true. TRIAL REGISTRATION DATE: 22 July 2020. DATE OF FIRST PATIENT’S ENROLMENT: 23 April 2021.