Evaluating the influence of Yoga, Cognitive Behaviour Therapy and Standard Care on Quality of Life and Healthcare Costs in Endometriosis

INTERVENTION: This trial tests yoga and cognitive‐behavioural therapy (CBT) CBT for chronic pain: Participants randomized to CBT will attend 8 weekly group CBT sessions of 120 minutes (minimum 10, max 13 participants/group) delivered by provisional psychologists under the supervision of a senior psychologist. The program draws on Beverly Thorn’s widely available CBT protocol for pain. The program aims to assist individuals to: gain an understanding of pain including education about chronic pain; learn practical strategies for managing pain and mood; practice the techniques both in and outside of the group setting, and; and learn how to maintain the gains they have made during therapy and prevent relapse. Participants will be encouraged to complete 20 min home practice (at least 3 days/week) involving working through the techniques introduced during sessions led by the therapist. The task for each week will be distributed via email. Adherence to the intervention will be monitored with attendance checklists. Yoga therapy: Participants randomized to yoga will attend 8 weekly group yoga sessions of 60 minutes (minimum 10, maximum 13 participants/group). Classes include: physical postures (suitable for all levels of experience, with adjustments for individual physical fitness and health issues); breath awareness and techniques; and relaxation and meditation. The yoga sequence will be based on vinyasa yoga in the tradition of T. Krishnamacharya, which emphasizes adaptations for health conditions. Classes will be led by experienced teachers. Adherence to the intervention will be monitored with attendance checklists. Before beginning classes, participants will attend a 60 minutes session with the yoga teacher to develop their home practice schedule, accounting for any inju CONDITION: Endometriosis;Pain;Fatigue; ; Endometriosis ; Pain ; Fatigue Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Endometriosis‐related quality of life measured by the 30‐item endometriosis Health Profile (EHP‐30)[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Generic quality of life measured by the EQ‐5D[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] INCLUSION CRITERIA: Diagnosis of endometriosis or suspected endometriosis by a physician, with pain for at least 6 months. For patients recruited via support groups, they will need to provide their histology and operation report. Other inclusion criteria are: English speaking; capacity to provide informed consent. SECONDARY OUTCOME: Adverse events measured by a patient self‐report measure after the intervention, and ongoing informal monitoring from the intervention therapists using a study‐specific questionnaire. Adverse events for CBT are very rare but can include deterioration of mental health, new psychological symptoms, and distress. Adverse events of yoga could involve musculoskeletal effects such as sprains and strains. [Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Anxiety measured by the Depression Anxiety Stress Scale ‐ 21 items (DASS‐21)[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Depression measured by the Depression Anxiety Stress Scale ‐ 21 items (DASS‐21)[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Employment measured by an employment questionnaire developed specifically for this study[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Fatigue measured by the Fatigue Symptom Inventory[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Pain measured by with the Brief Pain Inventory[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Participant feedback regarding the intervention and the planned dissemination strategies will be collected by semi‐structured audio‐recorded group interviews with a random selection of 10 participants in the yoga and CBT groups (total n=20). The aim of the interviews is to understand perceived barriers and enablers to CBT and yoga, and patients’ most significant change. [8 weeks] Patient health service utilisation measured by a patient health service utilisation questionnaire designed specifically for this study[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Stress measured by the Depression Anxiety Stress Scale ‐ 21 items (DASS‐21)[Baseline, post‐treatment at 8 weeks, 6 and 12 months since baseline] Treatment satisfaction measured with a 4‐point satisfaction scale designed specifically for this study.[Post‐treatment at 8 weeks]