Acceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme.

INTRODUCTION: Inflammatory bowel disease (IBD) involves an abnormal immune response to healthy gut bacteria. When a person develops IBD, their susceptibility to anxiety and/or depression increases. The ACTforIBD programme, specifically designed for people with IBD and comorbid psychological distress, draws on acceptance and commitment therapy (ACT), which promotes acceptance of situations that cannot be solved such as persistent physical symptoms. There are no ACT trials for IBD using an active control group or a telemedicine approach, which is important to improve accessibility, particularly in the context of the ongoing COVID-19 pandemic. The ACTforIBD programme is administered online with a 4-hour therapist involvement per participant only; if successful it can be widely implemented to improve the well-being of many individuals with IBD. METHODS AND ANALYSIS: Our team have codesigned with consumers the ACTforIBD programme, an 8-week intervention of 1-hour sessions, with the first three sessions and the last session delivered one-to-one by a psychologist, and the other sessions self-directed online. This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD. Using a randomised controlled trial, 25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition. ETHICS AND DISSEMINATION: This protocol has been approved by Deakin University Research Ethics Committee in September 2021 (Ref. 2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref. 2021 EXP 11384). The results of this research will be published in peer-reviewed journals and shared with various stakeholders, including community members, policy-makers and researchers, through local and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001316897.

Can an online expressive writing program support people with inflammatory bowel disease? A feasibility randomised controlled trial.

BACKGROUND: We explored feasibility, acceptability and preliminary efficacy of an online writing intervention (WriteforIBD) against an active control condition for distress in people with inflammatory bowel disease (IBD) at the time of the COVID-19 pandemic. METHODS: A feasibility RCT was conducted in 19 adults (89.5% female, aged 20-69 years) with IBD and mild-moderate distress. Participants allocated to the WriteForIBD group completed a 4-day 30-min writing program adapted for IBD. The active control group wrote about trivial topics provided by researchers. Feasibility was established based on the recruitment and retention while acceptability based on completion rates and a numeric rating scale. All participants completed measures of mental health and disease activity before and after the intervention (one week) and at follow-up three months after the study commencement. RESULTS: The retention rate in the study was high (100% WriteForIBD; 82% control). All participants attended every session. 84.2% of participants were satisfied with the intervention. All participants reported a significant improvement in IBD-Control immediately after the intervention; F (2, 33.7) = 7.641, p = .002. A significant interaction of group*time for resilience was noted, R2 = 0.19, p < .001, with the active control group reporting a significant decline in resilience from the first follow-up to three months while no significant change in resilience for the WriteForIBD group was recorded. CONCLUSIONS: Online expressive writing is potentially feasible and highly acceptable to people with IBD who report distress. Future large-scale trials should explore the intervention that is adapted from this feasibility study. REGISTRATION: ID: ACTRN12620000448943p.

Codesign and implementation of an equity-promoting national health literacy programme for people living with inflammatory bowel disease (IBD): a protocol for the application of the Optimising Health Literacy and Access (Ophelia) process.

INTRODUCTION: Non-government organisations (NGOs) often represent people who are underserved or experiencing vulnerability. Crohn's & Colitis Australia (CCA) is aware that many Australians with inflammatory bowel disease (IBD) are not reached by current communication and engagement activities. The aim of the CCA IBD project is to implement the Optimising Health Literacy and Access (Ophelia) process over 3 years to collaboratively codesign ways to improve delivery of information, services and resources for people with IBD and their carers. METHODS AND ANALYSIS: Health literacy and other data for phase 1 will be collected using the Health Literacy Questionnaire, eHealth Literacy Questionnaire, IBD-related questions and qualitative interviews with people with IBD and their carers to ascertain their lived experience. Quantitative data will be analysed using descriptive statistics and cluster analysis. Identified clusters will be combined with qualitative data to develop vignettes (narratives of people's experiences of living with IBD) for stakeholder workshops to generate ideas for useful, accessible and sustainable solutions for identified health literacy needs. Selection and testing of health literacy actions happens in phase 2 and implementation and evaluation in phase 3 (2021-2023). Outcomes of this project include giving voice to people living with IBD, their carers and frontline healthcare practitioners. Genuine codesign informs the development and implementation of what is needed and wanted to improve access to and availability and quality of information and resources that support people to manage their health. There is potential for other NGOs to use the CCA Ophelia model in other health contexts to improve engagement with and understanding of the needs of the people they serve and to reduce health inequalities and improve health outcomes. ETHICS AND DISSEMINATION: Ethics approval for Ophelia phase 1 has been obtained from the Human Research Ethics Committee of Swinburne University of Technology (Ref: 20202968-4652) and by the South West Sydney Local Health District Research and Ethics Office for the purposes of questionnaire recruitment at Liverpool Hospital (Ref: 20202968-4652). Dissemination of the study findings will be the national codesign process and ownership development across the CCA community and through the genuine engagement of clinicians and relevant managers across Australia. The model and process will be directly distributed to international IBD associations and to other NGOs. It will also be disseminated through publication in a peer-reviewed journal, conference presentations and public reports on the CCA and Swinburne University of Technology website.

Expressive writing to combat distress associated with the COVID-19 pandemic in people with inflammatory bowel disease (WriteForIBD): A trial protocol.

OBJECTIVE: A large proportion of patients with inflammatory bowel disease (IBD) receive immunosuppressive medication, may be at higher risk of complications if they contract SARS-CoV-2 virus, and therefore report high levels of COVID-19-related distress. This trial will evaluate a brief, evidence-based, online, group-based expressive writing intervention to reduce COVID-19-related distress in people living with IBD at the time of pandemic. METHODS: A parallel double-blind randomised controlled trial will be conducted. Overall, up to 154 adult participants with IBD and mild-moderate distress will be recruited via patient organisations. Participants will be allocated to the expressive writing intervention or an active control group. All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention. The expressive writing group will participate in the evidenced-based 4-day writing program adapted from Pennebaker and Beall, 1986. The active control group will write about untherapeutic topics provided by researchers. Statistical analysis will be carried out on an intention-to-treat basis and will involve linear mixed effects models. CONCLUSIONS: If successful, this simple intervention may bring personal and societal benefits, particularly because it is low cost, can be easily implemented online, ensuring social distancing, and be made widely available, during future disasters and to help with trauma-related distress in IBD. TRIAL REGISTRATION: The trial has been prospectively registered in the Australian New Zealand Trial Registry - ACTRN12620000448943p.