None listed
Conditions
Brief summary
Endometriosis is a chronic condition in which tissue similar to that lining the uterus grows on other organs, leading to scarring and adhesions and causing pain, menstrual irregularities, and infertility. Impacting 11% of Australian women and those assigned female at birth, endometriosis is under-recognised due to the variability in symptoms, reliance on surgery for diagnosis, and stigma of menstruation. Usual care, comprising of hormone and pain medications, has limited efficacy, is associated with adverse effects, and is discontinued by up to 40% of people. Recognising the inadequacy of the current biomedical healthcare approach to treating endometriosis, there is a need to address the complex psychosocial burden of endometriosis, and there are calls for urgent improvements in access to consumer-centred pain management. The current study will refine the structure and content of 'CodeEndo' – an online modular supportive care program for people living with endometriosis. The project will then evaluate the efficacy of the CodeEndo program using a randomised controlled trial, comparing it to waitlist control on quality of life and other important endometriosis-related biopsychosocial outcomes.
Interventions
CodeEndo is a online modular self-directed supportive care program for people living with endometriosis.
Phase 1: This phase will occur first, involving refining the structure and content of the CoDeEndo program, utilizing interviews and focus groups with consumers (i.e. those living with endometriosis) and collaboration with stakeholders (i.e. consumer representatives and endometriosis-related healthcare providers). The frequency and duration of interviews, focus groups, and collaboration will
CodeEndo is a online modular self-directed supportive care program for people living with endometriosis. Phase 1: This phase will occur first, involving refining the structure and content of the CoDeEndo program, utilizing interviews and focus groups with consumers (i.e. those living with endometriosis) and collaboration with stakeholders (i.e. consumer representatives and endometriosis-related healthcare providers). The frequency and duration of interviews, focus groups, and collaboration will occur on a needs basis throughout this phase and may include for example review of intervention materials, meetings, and online platform feedback. In this phase the final intervention will be created and embedded into an online platform, with the total duration of this phase being 1.5 years. Phase 2: This phase will follow phase 1, by evaluating the efficacy of the CoDeEndo program. The program will run for 8-weeks and includes 9 interventions each containing a number of sub-modules. The 9 interventions include - Mindfulness, Psychoeducation, Relaxation, Physiotherapy, Acceptance and Commitment Therapy, Hypnotherapy, Yoga, Cognitive Behavioral Therapy, and Dietary Education. Modules are comprised of a mix of video, audio, podcasts, and written resources. Participants will have access to all modules throughout the 8-weeks, allowing for observation of natural use. Participants will also be encouraged to practice (repeat) the modules throughout the 8-weeks. This means that participants can choose to spend as little as 5-mins to several hours per week accessing the CodeEndo Program. Participants will also receive weekly email reminders directing them to CoDeEndo. The specific goals of the intervention will vary for each person, depending on their individual symptoms, severity of disease, expectations and motivations, life experience, and what they want to achieve from the intervention. There are two strategies to monitor adherence to the intervention. 1) The website used to deliver the intervention has an inbuilt tracking system, which is able to provide detailed data regarding participant intervention usage. 2) Also embedded into the website are questions are the end of each module/week asking participants to self-report their usage of the intervention.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Trial Participants: Inclusion criteria: - Can provide proof of endometriosis diagnosis. (This can include a letter from a doctor, results of histology, operation reports, ultrasound scan, or any other medical document confirming their diagnosis). - Experiencing at least mild levels of psychological distress (score of 16 or above on K10) - Be Aged 18+. - Live in Australia. - Not pregnant. - Proficient in English.
Exclusion criteria
Trial Participants Exclusion criteria: - Recent endometriosis-related surgery within the last 3 months. - Currently participating in another research study related to pelvic pain, endometriosis or hypnotherapy. - No psychological distress (Screened via K10 - score of 15 or below). - Extreme dissociative experiences (screened via Brief Dissociative Experiences Scale (DES-B) - score of 2.5 or above). - Cognitive impairment (Screened via psychologist interview) - Suicide/Self-harm (Screened via psychologist interview) - Substance Use/Dependence (Screened via psychologist interview) - Bipolar I or Bipolar II (Screened via psychologist interview) - Schizophrenia/Psychosis (Screened via psychologist interview) - Post Traumatic Stress Disorder (Screened via psychologist interview) - Borderline Personality Disorder (Screened via psychologist interview)
Outcome results
None listed