{
  "abstract": "Introduction Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.Methods and analysis A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.Ethics and dissemination This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.Trial registration number ACTRN12623000598684p.",
  "authors": [
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Antonina Mikocka-Walus"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Colette Naude"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Yao Coitinho Biurra"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Lily Blake"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Jessica Bowring"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Samantha De Araugo"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Anna Bassili"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Shannon K Bennetts"
    },
    {
      "affiliations": [
        "School of Nursing and Midwifery & Institute for Health Transformation, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Alison M Hutchinson"
    },
    {
      "affiliations": [
        "National Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia",
        "School of Clinical Medicine, University of New South Wales, Randwick, New South Wales, Australia"
      ],
      "name": "Cecilia Hoi Man Ng"
    },
    {
      "affiliations": [
        "Faculty of Health, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Chatpakorn Prasertsung"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "David Skvarc"
    },
    {
      "affiliations": [
        "Academic Health Science Centre, Western Alliance, Warrnambool, Victoria, Australia"
      ],
      "name": "Drew Aras"
    },
    {
      "affiliations": [
        "Endometriosis Australia, Sydney, New South Wales, Australia"
      ],
      "name": "Donna Ciccia"
    },
    {
      "affiliations": [
        "Faculty of Health, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Eric O"
    },
    {
      "affiliations": [
        "Institute for Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, Victoria, Australia",
        "School of Medicine, Deakin University, Geelong, Victoria, Australia"
      ],
      "name": "Felice Jacka"
    },
    {
      "affiliations": [
        "Institute for Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, Victoria, Australia",
        "School of Medicine, Deakin University, Geelong, Victoria, Australia"
      ],
      "name": "Heidi M Staudacher"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Jane Varney"
    },
    {
      "affiliations": [
        "National Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia",
        "School of Clinical Medicine, University of New South Wales, Randwick, New South Wales, Australia"
      ],
      "name": "Jason Abbott"
    },
    {
      "affiliations": [
        "Kyo Yoga & Healing, Ocean Grove, Victoria, Australia"
      ],
      "name": "Jill Harris"
    },
    {
      "affiliations": [
        "Epworth HealthCare, Richmond, Victoria, Australia"
      ],
      "name": "Jim Tsaltas"
    },
    {
      "affiliations": [
        "NICM Health Research Institute, Western Sydney University, Penrith South, New South Wales, Australia"
      ],
      "name": "Justin Sinclair"
    },
    {
      "affiliations": [
        "Epworth HealthCare, Richmond, Victoria, Australia"
      ],
      "name": "Kate Tyson"
    },
    {
      "affiliations": [
        "EndoHelp Foundation, Melbourne, Victoria, Australia"
      ],
      "name": "Katherine Stanley"
    },
    {
      "affiliations": [
        "Faculty of Health, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Lahiru Russell"
    },
    {
      "affiliations": [
        "National Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia",
        "School of Psychological Science, University of Tasmania, Hobart, Tasmania, Australia"
      ],
      "name": "Leesa Van Niekerk"
    },
    {
      "affiliations": [
        "Faculty of Health, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Liliana Orellana"
    },
    {
      "affiliations": [
        "Royal Melbourne Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Madeleine Dober"
    },
    {
      "affiliations": [
        "School of Medicine, Deakin University, Geelong, Victoria, Australia",
        "University Hospital Geelong, Geelong, Victoria, Australia"
      ],
      "name": "Marilla L Druitt"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Melissa O’Shea"
    },
    {
      "affiliations": [
        "National Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia",
        "NICM Health Research Institute, Western Sydney University, Penrith South, New South Wales, Australia"
      ],
      "name": "Mike Armour"
    },
    {
      "affiliations": [
        "School of Health and Social Development, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Nikki McCaffrey"
    },
    {
      "affiliations": [
        "Bellarine Pelvic Health, Ocean Grove, Victoria, Australia"
      ],
      "name": "Natalie Anderson"
    },
    {
      "affiliations": [
        "Faculty of Health, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Patricia M Livingston"
    },
    {
      "affiliations": [
        "College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia"
      ],
      "name": "Rebecca O’Hara"
    },
    {
      "affiliations": [
        "Jean Hailes for Women's Health, Melbourne, Victoria, Australia"
      ],
      "name": "Sarah White"
    },
    {
      "affiliations": [
        "Department of Psychological Sciences, Swinburne University of Technology, Hawthorn, Victoria, Australia"
      ],
      "name": "Simon R Knowles"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Suiyin Cheah"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Susan Chesterman"
    },
    {
      "affiliations": [
        "Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia"
      ],
      "name": "Tiffany Brooks"
    },
    {
      "affiliations": [
        "School of Psychology, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Subhadra Evans"
    }
  ],
  "title": "Co-designing, evaluating and implementing online supportive care for endometriosis in Australia: study protocol for the hybrid type 1 effectiveness, cost-effectiveness and implementation randomised controlled trial of the CodeEndo program",
  "uid": "ecc05874-09d0-534f-bc32-615b3eab6aae"
}