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 biopsychosocial burden of endometriosis. The current project will be a small feasibility pilot trial to explore whether an adapted, online Acceptance and Commitment Therapy intervention is feasible and acceptable for this population. This study will form a part of a larger study (i.e., CoDeEndo, a hybrid type 1 efficacy and implementation randomised controlled trial evaluating a highly novel online multi-modular supportive care program for Australian adults living with endometriosis) for which ethics approval will be sought once this study is near completion.
Interventions
ACTforEndo is a modular, online, telehealth delivered acceptance and commitment therapy (ACT) based program for people living with endometriosis. This online intervention is an adaptation of a previously developed and tested ACT program and has been specifically tailored for this population. The aim of this study is to evaluate the acceptability, feasibility and preliminary efficacy of ACTforEndo (versus waitlist control)
In summary, ACTforEndo is a flexible, self-guided intervention, where the
ACTforEndo is a modular, online, telehealth delivered acceptance and commitment therapy (ACT) based program for people living with endometriosis. This online intervention is an adaptation of a previously developed and tested ACT program and has been specifically tailored for this population. The aim of this study is to evaluate the acceptability, feasibility and preliminary efficacy of ACTforEndo (versus waitlist control) In summary, ACTforEndo is a flexible, self-guided intervention, where the dose and content of the intervention is individualised to each participant based on their personal needs and attributes and overall program engagement. A suggested order for completion of the modules will be provided to participants, however this will not be compulsory and participants will have access to all module content. The intervention includes 6 self-directed, adapted modules comprising of a mix of video, audio, and written resources. The modules have been developed to address different ACT themes and processes to help better support and manage endometriosis-related experiences, thoughts, feelings and bodily sensations. The program includes experiential practices (such as meditation), practical worksheets and activities and reflective journalling, to help enhance quality of life, mental health, perceived pain and/or fatigue. The intervention is intended to be an adjunct support and will be provided during, and in addition to, the participant's usual care, as provided and administered by their healthcare practitioner(s) in line with agreed treatment practice. Participants will be asked to complete one module a week, for 6-weeks. Each recorded module will be up to 30-minutes in duration, with an estimated total weekly commitment not exceeding 1.5 hours. Participants will be provided a reminder about completing the following weeks module as required. Participant usage data will be collected to monotor adherence including online access date, log in / log out start and end time (total access/usage time), global session and sub-session use for individual users and group average. The specific goals of the intervention will vary for each person, depending on their individual symptoms, severity of disease, expectations, motivations, life experience, and what they want to achieve from the intervention.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be adults with a diagnosis of endometriosis by a qualified physician (confirmed by histology, operation reports, and/or ultrasound scan), capacity for consent, sufficient level of English to understand the intervention and be able answer relevant questionnaires via internet (individually or with support).
Exclusion criteria
Those with severe psychological distress (> or = to 30 as measured by the Kessler Psychological Distress Scale (K10) and those who have completed an acceptance and commitment therapy-based intervention or treatment program within the last 6 months will be excluded and provided with external support resources.
Outcome results
None listed