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

## TL;DR

Telehealth CBT improves quality of life and pain in endometriosis patients more than education, with yoga also showing some benefits.

## Contribution

First RCT testing telehealth CBT and yoga for endometriosis against an active control, showing CBT's superiority in pain and HRQoL.

## Key findings

- CBT significantly improved endometriosis-specific and general quality of life compared to education.
- CBT outperformed education in reducing pelvic pain and improving psychological outcomes.
- Yoga showed medium effects on menstrual symptoms and sexual pain compared to education.

## Abstract

Is telehealth cognitive behavioural therapy (CBT) or yoga effective in improving health-related quality of life (HRQoL) and secondary outcomes for endometriosis?

Endometriosis-tailored CBT is superior to education for improving HRQoL and pain.

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.

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 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.

The CBT group reported statistically significant improvements in endometriosis-specific HRQoL (EHP Pain β = −0.58, 95% CI = −0.89, −0.26, P = 0.01), and general HRQoL (EQ-5D-5L global health β = 0.52, 95% CI = 0.21, 0.84, P = 0.02) compared to the education control group. CBT was also superior to education for pelvic pain (menstrual pain, bowel pain, bladder pain, and sexual pain), pain self-efficacy, and pain catastrophizing. Effect sizes for CBT were generally medium to large (Cohen’s D = −0.28 to −0.93). Yoga was superior to education for menstrual symptoms and sexual pain, with medium effect sizes (Cohen’s D = −0.56 to −0.71).

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.

Our 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.

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.

ACTRN12620000756921 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379947&isReview=true.

22 July 2020.

23 April 2021.

WHAT DOES THIS MEAN FOR PATIENTS?Our randomized controlled trial (n = 334) comparing online cognitive behavioural therapy (CBT) or yoga to a control group sent education materials via email is the first to test the efficacy of these interventions for improving outcomes in people living with endometriosis. It is also the first study to test an endometriosis-specific CBT protocol delivered online, showing CBT is superior to an active control in improving health-related quality of life and pain. Given that one in nine reproductive-aged women is impacted by endometriosis, evidence based digital interventions are crucial for scalability and implementation. The results are likely to be particularly beneficial for people living in areas with limited access to specialized care.

Our randomized controlled trial (n = 334) comparing online cognitive behavioural therapy (CBT) or yoga to a control group sent education materials via email is the first to test the efficacy of these interventions for improving outcomes in people living with endometriosis. It is also the first study to test an endometriosis-specific CBT protocol delivered online, showing CBT is superior to an active control in improving health-related quality of life and pain. Given that one in nine reproductive-aged women is impacted by endometriosis, evidence based digital interventions are crucial for scalability and implementation. The results are likely to be particularly beneficial for people living in areas with limited access to specialized care.