None listed
Conditions
Brief summary
Afflicting more people than breast and prostate cancer, diabetes, and AIDS combined, endometriosis is a highly burdensome disease costing Australians more than $7.7 billion. In addition to pain, common symptoms include fatigue, anxiety and depression, and reduced quality of life (QoL). Poor psychological prognosis has led to urgent calls for treatments that address mental health to prevent further degradations in QoL. We will evaluate the efficacy and cost effectiveness of 1) yoga, and 2) cognitive behaviour therapy (CBT), compared to 3) standard care receiving patient education. Our systematic review identified that yoga and CBT hold promise in improving pain and mental health in endometriosis. Yoga is likely to improve wellbeing via the benefits of movement, and relaxation through breath regulation and meditation, potentially benefiting inflammation, stress, pain, and emotion regulation. CBT is purported to improve QoL by correcting maladaptive thoughts, developing self-efficacy and coping, and increasing engagement in life tasks. However, thus far only pilot studies exist. We propose a step change in our understanding of the potential impact of yoga and CBT by undertaking a full-scale randomised controlled trial using gold-standard methodology. We will provide high quality evidence for CBT and yoga and their impact on endometriosis.
Interventions
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) either in person or online, 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 abo
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) either in person or online, 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) either in person or online. 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 yoga therapists. Adherence to the intervention will be monitored with attendance checklists. Before beginning classes, participants will attend a 60 minutes session with the yoga therapist to develop their home practice schedule, accounting for any injuries or health issues. Participants will be encouraged to complete 20 min home practice (at least 3 days/week)- involving simple movement and breathing techniques, with the aim of setting a new positive pattern for participants to continue after study completion. These sessions will be monitored for the duration of the intervention. Patient’s home practice fidelity and adherence will be measured with a logbook.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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, not currently pregnant, have no major physical issues or injuries, and have not recently completed a course of therapist led yoga or CBT.
Exclusion criteria
High risk of harming self or others or unsuitable for group treatment (e.g. severe mental illness/addiction or cognitive impairment), as confirmed during psychological screening.
Outcome results
None listed