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Introduction: As a high symptom burden chronic condition, endometriosis is associated with diminished quality of life (QoL) and psychological distress. The EndoSMS text message intervention was developed to inform and support individuals living with endometriosis. The primary aim of this study is to assess the acceptability, feasibility and preliminary efficacy of EndoSMS, to improve endometriosis-specific QoL and reduce psychological distress in a randomised controlled trial, compared with care as usual. We will additionally assess the impact of EndoSMS on self-efficacy for managing endometriosis. Methodology: A two-arm parallel pilot randomised controlled trial with waitlist control was conducted. Baseline assessments included QoL, psychological distress, self-efficacy, demographic and medical variables. Following baseline survey completion, participants were randomised to either the Intervention (EndoSMS: 3-months of text messaging) or Control condition. At 3-month follow-up, all participants completed an online survey reassessing outcomes, and Intervention participants provided quantitative and qualitative user feedback on EndoSMS. Results: Data collection commenced on 18 November 2021 and was completed on 30 March 2022. Descriptive statistics will be used to analyse feasibility and acceptability of the intervention. Preliminary efficacy analyses will be conducted using linear mixed models for QoL, psychological distress and self-efficacy outcomes. Subgroup analyses will also be conducted for typically underserved populations (e.g., rural/regional). Conclusion: This pilot will provide acceptability, feasibility and preliminary efficacy evidence for the impact of a supportive text messaging program for endometriosis. It will contribute to understanding how to optimally support individuals in living with and managing their endometriosis. Trial Registration: Australian New Zealand Clinical Trials Registry.
RESUMEN
BACKGROUND: Endometriosis, which affects 1 in 10 people assigned female at birth, is a chronic systemic inflammatory disease with a high symptom burden and adverse socioemotional impacts. There is a need for an accessible, cost-effective, and low-burden intervention to support individuals in managing their endometriosis condition. OBJECTIVE: This study aimed to co-design and evaluate the acceptability, readability, and quality of a bank of supportive SMS text messages (EndoSMS) for individuals with endometriosis. METHODS: In phase 1 of this mixed method design, 17 consumer representatives (individuals with endometriosis) participated across three 3-hour web-based (Zoom, Zoom Video Communications, Inc) focus groups. The transcripts were encoded and analyzed thematically. In phase 2, consumer representatives (n=14) and health care professionals (n=9) quantitatively rated the acceptability, readability, and appropriateness of the developed text messages in a web-based survey. All the participants initially completed a background survey assessing sociodemographic and medical factors. RESULTS: Consumer representatives demonstrated diverse sociodemographic characteristics (Mage=33.29), varying in location (metropolitan vs rural or regional), employment, and relationship and educational statuses. Participants reached a consensus regarding the delivery of 4 SMS text messages per week, delivered randomly throughout the week and in one direction (ie, no reply), with customization for the time of day and use of personal names. Seven main areas of unmet need for which participants required assistance were identified, which subsequently became the topic areas for the developed SMS text messages: emotional health, social support, looking after and caring for your body, patient empowerment, interpersonal issues, general endometriosis information, and physical health. Through a web-based survey, 371 co-designed SMS text messages were highly rated by consumers and health care professionals as clear, useful, and appropriate for individuals with endometriosis. Readability indices (Flesch-Kincaid scale) indicated that the SMS text messages were accessible to individuals with a minimum of 7th grade high school education. CONCLUSIONS: On the basis of the needs and preferences of a diverse consumer representative group, we co-designed EndoSMS, a supportive SMS text message program for individuals with endometriosis. The initial evaluation of the SMS text messages by consumer representatives and health professionals suggested the high acceptability and suitability of the developed SMS text messages. Future studies should further evaluate the acceptability and effectiveness of EndoSMS in a broader population of individuals with endometriosis.
RESUMEN
Endometriosis is a chronic systemic disease affecting 1 in 10 people assigned female at birth, that can result in appearance-based and functional bodily changes which can negatively impact body image. Empirical evidence supports the body dissatisfaction-driven hypothesis that negative body image leads to greater depressive symptoms; but potential underlying mechanisms are under-researched. This prospective study investigated the mediating role of two theoretically-derived intervening factors, self-esteem and rumination, in individuals living with endometriosis who typically report high rates of body image concerns and depressive symptoms. Initially, 996 participants completed the first online survey (T0) assessing demographic, medical and psychological factors. Of these, 451 completed surveys at 1-month (T1) and 2-months (T2) follow-up assessing self-esteem, rumination and depression. Bootstrapped analyses with full-information maximum likelihood estimation indicated that poor body image (T0) predicted greater depressive symptoms over time (T2). Self-esteem (T1), but not rumination (T1), mediated the body image-depression relationship. These results provide support for the body dissatisfaction-driven hypothesis and further identify that self-esteem is a key meditating factor. This highlights the importance of addressing self-esteem in body image focused interventions.