Moving Towards Acceptance and Values: A Qualitative Study of ACTforIBD Compared to IBD Psychoeducation.

The current study explored perspectives of those with inflammatory bowel disease (IBD) and comorbid anxiety and/or depression on a hybrid acceptance and committment therapy (ACT) intervention, compared to an active control. This qualitative study was nested within a randomized controlled trial (RCT) where an experimental group received an 8-week blended delivery ACTforIBD intervention (four sessions telehealth, four sessions pre-recorded self-directed), while an active control group received a psychoeducation program of similar intensity. Semi-structured interviews were conducted post-intervention and at a 3-month follow-up. Themes were interpreted using reflexive thematic analysis. Twenty individuals participated; ten in each condition. Seven themes were constructed, including three shared themes between groups: I Am Worth Advocating For, Present Moment Is My Biggest Ally, and Ambivalence About Self-Directed Modules. Two themes were identified for the ACTforIBD group: Symptoms Are Going to Happen and Moving Toward Values while two themes identified from the ActiveControl group were: Reset and Refresh and It's Ok to Say No. Acceptance and values modules from ACTforIBD were perceived as useful in reducing psychological distress for those with IBD, while the ActiveControl group felt their program affirmed existing effective coping strategies. Access to external resources for self-directed modules and networking may increase engagement with content long term.

Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn's perianal fistulas.

BACKGROUND: Patients with Crohn's disease (CD) are at risk of developing complications such as perianal fistulas. Patients with Crohn's perianal fistulas (CPF) are affected by fecal incontinence (FI), bleeding, pain, swelling, and purulent perianal discharge, and generally face a higher treatment burden than patients with CD without CPF. AIM: To gain insights into the burden of illness/quality of life in patients with CPF and their treatment preferences and satisfaction. METHODS: This cross-sectional observational study was conducted in patients with CD aged 21-90 years via a web-enabled questionnaire in seven countries (April-August 2021). Patients were recruited into three cohorts: Cohort 1 included patients without perianal fistulas; cohort 2 included patients with perianal fistulas without fistula-related surgery; and cohort 3 included patients with perianal fistulas and fistula-related surgery. Validated patient-reported outcome measures were used to assess quality of life. Drivers of treatment preferences were measured using a discrete choice experiment (DCE). RESULTS: In total, 929 patients were recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135). Short Inflammatory Bowel Disease Questionnaire scores were worse for patients with CPF (cohorts 2 and 3) than for those with CD without CPF (cohort 1): Mean score 3.8 and 3.7 vs 4.1, respectively, (P < 0.001). Similarly, mean Revised FI and FI Quality of Life scores were worse for patients with CPF than for those with CD without CPF. Quality of Life with Anal Fistula scores were similar in patients with CPF with or without CPF-related surgery (cohorts 2 and 3): Mean score 41 and 42, respectively. In the DCE, postoperative discomfort and fistula healing rate were the most important treatment attributes influencing treatment choice: Mean relative importance 35.7 and 24.7, respectively. CONCLUSION: The burden of illness in CD is significantly higher for patients with CPF and patients rate lower postoperative discomfort and higher healing rates as the most desirable treatment attributes.

Feasibility, Acceptability, and Preliminary Efficacy of Acceptance Commitment Therapy for Adults Living With Inflammatory Bowel Disease and Distress.

BACKGROUND: The bidirectional relationship between inflammatory bowel disease (IBD) flare-ups and depression/anxiety symptoms has prompted investigations into psychotherapy to improve health-related quality of life (HRQoL) by targeting depression and anxiety. Acceptance commitment therapy (ACT) is effective in improving symptoms of depression and anxiety in people with chronic diseases, yet minimal research has examined ACT's effectiveness for IBD. This study examines the feasibility, acceptability, and preliminary efficacy of the ACTforIBD program, an online program codesigned with consumers to deliver ACT to those with IBD. METHODS: Adults with IBD and symptoms of mild-moderate distress were randomized to ACTforIBD or an active control (psychoeducation) condition. Participants completed 8 weekly, 1-hour sessions, 4 of which were therapist facilitated. Feasibility was based on recruitment and retention and acceptability was derived from postprogram satisfaction measures. Preliminary efficacy was determined by group differences in rate of change in study outcomes from baseline to postprogram. RESULTS: Of 62 participants (89% women, 11% men; mean age  33 years), 55 completed the program (ACTforIBD: n = 26 [83.9%]; active control: n = 29 [93.5%]). Adherence and acceptability were high in the ACTforIBD group, with 80% of participants completing all self-directed modules and 78% of participants expressing satisfaction with the program. Significant and marginally significant group × time interactions were found for anxiety symptoms (b = -1.89; 95% confidence interval, -3.38 to -0.42) and psychological HRQoL (b = -0.04; 95% confidence interval, -0.07 to 0.01), showing decreased anxiety and increased psychological HRQoL in the intervention group. CONCLUSIONS: ACTforIBD is feasible, acceptable, and improved anxiety symptoms, and psychological HRQoL. This highlights the need for a full-scale randomized controlled trial to further examine the program's efficacy.

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.

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.

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.

Psychological distress is highly prevalent in inflammatory bowel disease: A survey of psychological needs and attitudes.

BACKGROUND AND AIM: Data on patient needs and access to psychological services in inflammatory bowel disease (IBD) are scarce. This study aimed to describe the levels of distress and the needs, attitudes, and access to psychological services for people within Australia against established Australian IBD Standards. METHODS: An online cross-sectional survey was conducted with Australians ≥16 years old recruited via Crohn's & Colitis Australia membership, public and private clinics, and the Royal Flying Doctor Service. K10 was used to measure psychological distress. The Chi-square test was used to compare those with and without distress on key variables. RESULTS: Overall, 731 respondents provided complete data (71.5% female, mean age 46.5 years). Overall, 50% of respondents reported distress; only 15.2% were currently seeing a mental health practitioner; only 16.1% were asked about their mental health by their IBD specialist or IBD nurse; and only 12.2% reported access to a mental health practitioner as part of their IBD service. Those with psychological distress were significantly less satisfied with their IBD care; more commonly hospitalized; had an active disease, fistula or perianal disease, pain, or fatigue; and were receiving steroids, opioids, or antidepressants (all P < 0.05). As many as 68.2% of those with severe distress were not seeing a mental health practitioner. CONCLUSIONS: The integrated biopsychosocial model of health care, with regular mental health screening and good access to mental health professionals, is requested by people living with IBD to improve their outcomes.

Quality of care in inflammatory bowel disease: actual health service experiences fall short of the standards.

BACKGROUND: Quality of care in inflammatory bowel disease (IBD) has received much attention internationally; however, the available surveys focus on health professionals rather than patients. AIMS: To assess the experiences of healthcare for people living with IBD against established Australian IBD Standards. METHODS: An online cross-sectional survey was conducted with Australians ≥16 years old recruited via Crohn's & Colitis Australia membership, public and private clinics and the Royal Flying Doctor Service. Participants completed a questionnaire incorporating items addressing the Australian IBD Standards 2016, the Picker Patient Experience Questionnaire, IBD Control Survey and the Manitoba Index. RESULTS: Complete data were provided by 731 respondents (71.5% female, median age 46 years, ranging from 16 to 84 years). While the majority (74.8%) were satisfied with their IBD healthcare, the care reported did not meet the Australian IBD Standards. Overall, 32.4% had access to IBD nurses, 30.9% to a dietician and 12% to a psychologist in their treating team. Participants managed by public IBD clinics were most likely to have access to an IBD nurse (83.7%), helpline (80.7%) and research trials (37%). One third of respondents reported waiting >14 days to see a specialist when their IBD flared. Participants received enough information, mostly from medical specialists (88.8%) and IBD nurses (79.4%). However, 51% wanted to be more involved in their healthcare. CONCLUSIONS: These data show discordance between expectations of patients and national standards with current levels of service provision, which fail to deliver equitable and comprehensive IBD care.

Research Priorities in Sudden Unexpected Infant Death: An International Consensus.

Despite the success of safe sleep campaigns and the progress in understanding risk factors, the rate of reduction in the cases of sudden infant death syndrome has now slowed and it remains a leading cause of postneonatal mortality in many developed countries. Strategic action is needed to tackle this problem and it is now vital to identify how the sudden infant death research community may best target its efforts. The Global Action and Prioritization of Sudden Infant Death Project was an international consensus process that aimed to define and direct future research by investigating the priorities of expert and lay members of the sudden unexpected infant death (SUID) community across countries. The aim was to identify which areas of research should be prioritized to reduce the number of SUID deaths globally. Scientific researchers, clinicians, counselors, educators, and SUID parents from 25 countries took part across 2 online surveys to identify potential research priorities. Workshops subsequently took place in the United Kingdom, United States, and Australia to reach consensus and 10 priority areas for research were established. Three main themes among the priorities emerged: (1) a better understanding of mechanisms underlying SUID, (2) ensuring best practice in data collection, management and sharing, and (3) a better understanding of target populations and more effective communication of risk. SUID is a global problem and this project provides the international SUID community with a list of shared research priorities to more effectively work toward explaining and reducing the number of sudden infant deaths.

Responding to evidence: breastfeed baby if you can--the sixth public health recommendation to reduce the risk of sudden and unexpected death in infancy.

Abundant evidence recognises breastfeeding as being associated with significant short and long-term health benefits for both infant and mother. Until recently, the role of breastfeeding as an independent factor in reducing risk for sudden unexpected infant death remained unclear. In October 2010, SIDS and Kids Australia held a consensus forum with international researchers and key stakeholders to review current evidence relating to safe infant sleeping recommendations. Following this forum and the publication of key reviews, the SIDS and Kids National Scientific Advisory Group has supported the decision that a critical threshold had been reached within the evidence that is supportive of breastfeeding as a specific risk reduction measure for sudden unexpected death in infancy. A sixth recommendation, Breastfeed baby if you can, will be included in the 2012 SIDS and Kids Safe Sleeping national public health campaign.