key: cord-0819088-44mejwfn authors: Mikocka-Walus, Antonina; Olive, Lisa; Skvarc, David; Beswick, Lauren; Massuger, Wayne; Raven, Leanne; Emerson, Catherine; Evans, Subhadra title: Expressive writing to combat distress associated with the COVID-19 pandemic in people with inflammatory bowel disease (WriteForIBD): A trial protocol date: 2020-11-04 journal: J Psychosom Res DOI: 10.1016/j.jpsychores.2020.110286 sha: d6fd5c9f88184e3f23d5764bc2c232b0d0264169 doc_id: 819088 cord_uid: 44mejwfn 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. The COVID-19 pandemic presents significant risks to the mental health of people living with chronic health problems. This project evaluates an expressive writing intervention to help people living with inflammatory bowel disease (IBD) cope with distress related to SARS-CoV-2 virus and COVID-19 (i.e., a disease resulting from the virus) at the time of the COVID-19 pandemic. IBD is an inflammatory condition affecting 3 million people in the United States [1] and 85,000 Australians, with symptoms including diarrhoea, faecal urgency, rectal bleeding, abdominal pain, and fatigue. IBD is chronic and increasingly considered a disease of braingut interaction, with emerging evidence of the bi-directional brain-gut and gut-brain links [2] , translating into a significant mental illness comorbidity (i.e. >60% of patients report clinically significant anxiety during disease flares [3] ). A large proportion of patients with IBD receive immunosuppressive medication and may be at higher risk of complications if they contract SARS-CoV-2 virus. A recent survey showed that 64% of 3815 respondents reported that immunosuppressive drugs increased risk of infection and 30% believed that IBD itself increases the risk of developing COVID-19 [4] . In addition, the recent COVID-19 related product shortages, specifically those relating to medication, protective equipment and toilet paper, but also challenges in accessing care, have presented a novel and additional stressor for this population. Further, isolation enforced by the governments in some countries or self-imposed to protect oneself from the virus is yet another stressor and a possible contributor to future risks of social anxiety. These factors have resulted in significant distress expressed by the members of the IBD community [5] . For example, a COVID-19 focused survey (n=124) showed that close to 50% of patients with IBD reported moderate to severe symptoms of anxiety and 20% of depression [6] . To date, studies have not documented positive aspects of COVID-19 pandemic for those with IBD but these could potentially include lower distress due to not being faced with anxiety-provoking situations such as lack of knowing where the toilet is, lack of stress associated with travel, work or socialising. Nonetheless, these potential benefits are likely to be overshadowed by the overwhelming fear of catching the virus or infecting others [4] . Psychotherapy trials for those living with IBD who report distress are scarce [7] , with most existing trials testing interventions with unselected IBD samples (i.e. anyone with IBD) and focused on disease activity. No psychological interventions focused on coping with the stress of the COVID-19 pandemic has been conducted in an IBD population to date. Such interventions can facilitate individual's processing of challenging situations more effectively and facilitate emotional regulation resulting in improved physical and psychological functioning. Disclosing one's thoughts and feelings (experimental disclosure) concerning difficult events through expressive writing has been shown to lead to broad health improvements. A major comprehensive meta-analysis on experimental disclosure (n=146 RCTs) demonstrated significant improvements in psychological outcomes, including distress, anxiety, depression, anger, positive functioning and ability to make sense of a traumatic event [8] . In terms of physiological and health outcomes, significant improvements were seen in immune functions, specific disease outcomes and illness behaviours. Work-related outcomes and social relationships were also significantly improved (with small to medium effect sizes ranging from -0.291 to 0.592). A more recent meta-analysis on expressive writing in cancer (n=13 J o u r n a l P r e -p r o o f Journal Pre-proof RCTs) showed significant (though small) improvements in cancer symptoms and quality of life [9] . However, while expressive writing interventions are effective for a variety of outcomes and have high satisfaction, some participants do not perceive them as helpful or engaging and their efficacy is dependent on individual differences, e.g., optimists observe greater benefits [8, 10] . Several theories propose how expressive writing may improve a broad spectrum of outcomes. Inhibition theory links its effects to Freudian concept of catharsis where expression of inhibited thoughts and feelings may release stress and consequently improve other biopsychosocial outcomes. However, experimental research has shown that people equally benefit from writing about imaginary emotions and thus it is doubtful that writing helps through releasing unresolved internal conflicts [11] . Cognitive-processing theory posits that writing helps via allowing people to gain insight into what they have experienced, to make sense of a traumatic event and integrate a difficult experience into their self-concept [12] . Self-regulation theory proposes that writing creates opportunities to observe oneself expressing and controlling emotions, boosting one's self-efficacy in regulating emotions [13] . The social integration model experimental proposes that writing interventions work because they change the way people interact with their social world [14] . The exposure model compares writing about a traumatic event to flooding therapy useful in treating PTSD via confronting and relieving trauma and eventually extinction of unpleasant thoughts and feelings [15] . Each of the models has been critiqued in the recent meta-analysis but the greatest support is available for the exposure model [8] . Pennebaker's expressive writing intervention has been one of the first and most influential expressive writing interventions to date [16] , comprising four short writing sessions, with its various derivatives tested widely [8] . In the context of gastroenterology, it has been piloted in one non-randomised trial, which included patients with irritable bowel syndrome (IBS, n=103) [17] . Significant improvements at 1 and 3 months were observed in IBS severity. To date, no randomised control trials of expressive writing have been conducted on inflammatory gut conditions, such as Crohn's disease and ulcerative colitis (subtypes of IBD). Expressive writing offers promise for IBD patients since it may improve immune functions and reduce distress [8] . Following the recommendations from the meta-analyses on expressive writing and the relevant study on IBS [8, 17, 18] , we propose to adapt Pennebaker's evidencebased intervention by adding an element of gratitude writing. Although good-quality systematic reviews are lacking on the effect of gratitude writing, some early trials (n=293) reported its significant benefits [19] on mental health as compared to no intervention controls or expressive writing controls. Gratitude, and a related concept of resilience (i.e. human ability to bounce back from adversity), can protect victims of disasters against post-traumatic stress, with resilience acting to prevent an adverse response to trauma and gratitude promoting positive outcomes post-trauma [20] . In the IBD context, resilience has been associated with lower disease activity and fewer surgeries as well as improved quality of life [21] . Further, since the literature supports the exposure model as the most likely explanation of how writing interventions work [8] , the benefits to those with IBD may be because of the high co-morbidity of IBD with post-traumatic stress disorder [22] and because those with history of trauma (IBD diagnosis is often considered a traumatic experience) respond particularly well to writing interventions [8] . Further, of all the examined outcomes, writing interventions are J o u r n a l P r e -p r o o f Journal Pre-proof particularly effective for distress, immune parameters, specific disease outcomes, with higher effect sizes reported in those with pre-existing physical health problems [8] . In addition, stress is a significant moderator of the effect of writing interventions, with those reporting high stress receiving greatest benefits. Those with IBD report very high perceived stress which has been associated with poor disease activity [23, 24] . Finally, convincing meta-analytic evidence [8, 18] demonstrates that expressive writing may be: 1. particularly useful to participants with poorer health (higher reported health effect sizes than in other populations) 2. more effective when undertaken at participants' home (higher psychological health effect sizes than studies in which participants wrote in a controlled setting) 3. more effective if sessions last at least 15 minutes (larger effect sizes than studies with sessions that lasted less than 15 min) 4. more effective when the intervention includes three or more sessions (marginally larger effect sizes than studies with fewer than three sessions) 5. more effective when participants write about recent challenging events (larger effect sizes compared to older events) 6. more effective when participants are asked to write about specific questions or examples (larger effect sizes than studies that did not give directed questions or examples) 7. more effective when participants are not asked to hand in their writing to the investigators (marginally higher psychological health effect sizes than studies in which participants turned in their writing) 8. equally effective if handwritten or typed. 9. more effective when facilitated rather than unfacilitated. Therefore, we designed our brief facilitator-assisted online intervention, specifically following the above evidence-based strategies and propose to investigate: Whether the expressive writing intervention improves patient distress compared with an active control group at post-intervention and 3 months since baseline. Whether the expressive writing intervention improves patient anxiety, depression, stress, disease activity, quality of life, resilience, self-efficacy and sense of isolation at postintervention and 3 months since baseline. We hypothesise that our expressive writing intervention will have a significant and positive impact on the symptoms of distress as compared to an active control condition. This protocol has been approved by the Deakin University Human Research Ethics Committee in May 2020 (Ref. 2020-122). The trial was prospectively registered in the Australian New Zealand Trial Registry on 06 April 2020 (ID: ACTRN12620000448943p). The trial is likely to start recruiting in June 2020 and complete recruitment by July 2021. Figure 1 for a study design overview. A parallel randomised double-blind controlled trial, involving intention to treat analyses will be conducted. Participants will be randomly allocated to one of two groups: expressive writing intervention or active control, with a ratio of 1:1. Simple randomisation, with no blocks, using a randomisation table created by computer software (i.e. computerised sequence generation) will be used. Allocation will involve contacting the holder of the allocation schedule (the study statistician) who is based at central administration site with no access to participants. No stratification is envisaged. Participants, as well as research staff assessing outcomes and analysing the data will be blinded to group allocation, with masking and an active control condition used for participants. Participants in both treatment arms will remain on their current IBD medication. All participants will complete questionnaires before and after the intervention (1 week) and at 3 months since baseline. Inclusion criteria:  Diagnosis of IBD: Crohn's disease, ulcerative colitis or indeterminate colitis established using standard criteria (we will ask participants for the details of their gastroenterologist, and these will be verified by our team);  Distress: at least mild distress on K10 (scores 20-29);  Age: 18 years and older; receiving care in Australia, New Zealand or Singapore, able to read and write in English, with access to internet to participate in online intervention, able to download Zoom and available to participate for approximately 30 minutes for 4 consecutive days. Exclusion criteria:  No distress based on K10 (scores under 20) as the intervention targets distress.  Severe distress based on K10 (scores 30-50 very high distress) as it is anticipated that these participants would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will be contacted individually by the research team to indicate they are not eligible to participate due to screening highly for severe distress. We will then recommend that they seek additional support from their GP or other appropriate providers. Withdrawal criteria: Participants are free to withdraw at any time. We will ask about their reasons for withdrawal for statistical and reporting purposes but answering this question will not be compulsory. No aspect of participant IBD care will be affected by their decision to withdraw from the study. We will monitor dropout/attrition closely to be able to establish satisfaction with the intervention. Expressive writing intervention -This group will participate in the adapted evidencedbased [25] 4-day writing program. Participants will meet with the facilitator using Zoom four times in one week for approx. 30 minutes (25 minutes of writing time). Privacy of sessions will be ensured by using Zoom passwords and the waiting rooms which allow the facilitator to monitor who joins the session. Daily e-mail reminders about the online sessions will be sent during the 4 days of writing. The instruction each day will be (adapted from Pennebaker [25] ) ( Table 1 ). Participants will not need to share their writing with the study investigators to ensure free expression. Active control -This group will write about trivial untherapeutic topics provided by researchers (Table 1 ) for 4 consecutive days. Participants will meet with the facilitator using Zoom (audio required, video use is optional) four times in one week for approx. 30 minutes (25 minutes of writing time). Daily e-mail reminders will be sent during the 4 days of writing. On request, the active control group will be offered self-directed version of the intervention after the final follow-up. The intervention will be facilitated by Psychology research students. Facilitators will provide the intervention interchangeably to different groups (i.e., each facilitator will deliver intervention in both groups). See Table 1 for detail of intervention structure. Table 2 details the measures used in this study, including their scoring and assessment time. Participants will be recruited online via social media. They will be asked to email the researchers if they are interested in participating. They will then be asked to read and consider the study's Plain Language Statement and, if still interested, to sign a consent form and return to the investigators via email. Participants will then be asked to complete K10 to ensure their distress is within the mild-moderate range. Those eligible will then be asked to complete all the remaining baseline measures. Participants will be given codenames to facilitate data collection at multiple times. Participants will then be randomised to one of the two groups, informed about the starting date and sent the Zoom link with any necessary instructions. During each session, participants will be reminded they are not required to use video. They only need to be able to hear the facilitator. The facilitator will then provide the link to the distress VAS measure and after its completion writing will start. At the end of the session, the facilitator will provide the participants with another link to the distress VAS measure (both via Qualtrics). Sessions will continue for 4 consecutive days and attendance will be recorded each day. After the final day of the intervention the participants will be asked to complete the post-intervention measures. They will then be contacted after 3 months to complete the follow-up measures. Participants who complete the study including the 3month follow-up will be entered into a prize draw for one of ten AU $50 online gift vouchers. At the trial completion, participants will be debriefed about their group allocation. Two large, comprehensive meta-analyses on the beneficial effect of therapeutic writing for psychological distress in chronic disease suggest small improvements to psychological wellbeing compared to control and indicate that the effect is magnified in the presence of facilitators [8, 18] . As such, we power the study for a small but meaningful between-groups effect at post-intervention of standardised mean difference = 0.3. Using an alpha level of .05 Journal Pre-proof and 80%, a minimum sample size of n = 128 is required. We assume a drop-out of 20%, so will recruit 154 persons (77 per group). We will use Qualtrics to collect the data at 3 time points and before/after each writing session. The data will then be transferred into SPSS for analysis. The data will be anonymized by adding code names. The files containing personal or identifiable data will be encrypted or password protected. Analyses will be carried out on intention-to-treat basis, and significance tests will be two-sided at the 5% level. No adjustment for multiple testing will be made to p-values, however, effect sizes for each outcome measure will be presented. The study hypothesis will be tested with a series of linear mixed effects models, which are known to compensate for missing data. In these models, the dependent variable is the outcome measure, with predictors being Time, Group and the Interaction between Time and Groupthe coefficient for Interaction being the formal test of the hypothesis. A per protocol analysis will also be undertaken, with adjustment for adherence to intervention. The latter will be defined as ≥80% of sessions completed. Other adjustments (e.g., age, sex, disease activity, IBD treatment type) will be made, if required. IBD is increasingly considered a disease of brain-gut interaction, with emerging evidence of the bi-directional brain-gut and gut-brain links [2] , which translates into a high prevalence of anxiety and depression [3] . Conversely, anxiety and depression co-exiting with IBD have a significant impact on disease outcomes, such as IBD flares [26] , disease presentation [27] , hospital readmissions and surgery [28] . Even during remission, 28% and 20% of patients report symptoms of anxiety and depression, respectively, while these rates rise to 66% and 35% during IBD relapses [3] . Therefore, a large proportion of this population could benefit from psychological screening and treatment. Yet, while the international IBD guidelines [29] and the Australian IBD Standards [30] recommend regular screening for symptoms of mental illness and incorporating mental healthcare in IBD management, very few (12.2%) patients actually receive the psychological help they need [31, 32] . A recent meta-analysis has showed that psychotherapy, and particularly cognitivebehavioural therapy (CBT), improves quality of life and symptoms of depression in patients with IBD [7] , but also disease-related outcomes such as pain in other common gastrointestinal conditions [33] . Other psychotherapies, for example those targeting trauma, are increasingly being tested in gastroenterology in hope to identify alternatives for those people not engaging or responding to CBT. One example is emotional awareness and expression therapy which has been shown to reduce bowel symptoms and improve quality of life in patients with irritable bowel syndrome in a recent RCT [34] . The proposed intervention will further contribute to the enquiry into the role of expressive interventions in gastroenterology populations. Minimal contact therapies have not received much attention in gastroenterology, although the preliminary evidence is promising in terms of reducing healthcare seeking behaviour [35] . In IBD specifically, little research on low intensity or online psychotherapy is available [7] . Given poor access to psychological care reported by people with IBD [36] , minimal contact online and low cost therapies such as the proposed intervention have a potential to fill the current gap in services. Further, the recent meta-analysis highlighted a dearth of interventions J o u r n a l P r e -p r o o f focused on people "in need" of psychological therapy (e.g. those with comorbid distress), as most available trials have focused on the unselected patients with IBD (anyone with the diagnosis). To date, there have been no studies focused on expressive writing in people with IBD, very few online psychotherapies designed for people with IBD specifically or targeting distress particularly at the time of adversity, for example major disasters such as the COVID-19 pandemic. Offering solutions to address high levels of distress currently experienced by the members of the IBD community is paramount to improving patients' emotional wellbeing. It can potentially also prevent stress-related flares, which can have serious implications for patients but also cost healthcare systems, already weakened by the COVID-19 pandemic. In addition, more research is needed on moderators of psychological intervention effects in IBD. While a large number of moderators have been examined in previous writing interventions [8] , understanding IBD-specific moderators such as IBD activity and complications (e.g., fistulas), but also broader factors which have not been extensively studied in previous writing interventions for chronically ill cohorts such as disease duration, social support, self-efficacy, and resilience may help explain current limited long-term effects of psychotherapy in IBD [7] and inform future trials of tailored interventions for the subgroups likely to benefit. Other researchers have started pinpointing moderators relevant to gastrointestinal cohorts[37]. If effective, this simple intervention can be a useful tool for patients and multidisciplinary health professionals supporting the IBD community. More broadly, the intervention can bring personal and societal benefits, particularly because it is low cost, can be easily implemented online, ensuring social distancing, and be made widely available throughout Australia and internationally, during future disasters and to help with trauma-related distress in IBD. While expressive writing has proven efficacy in reducing distress and improving broad biopsychosocial outcomes in a variety of contexts, many interventions conducted to date have produced small-moderate effect sizes [8] . Effect sizes for psychological interventions are generally low (e.g., 0.2 for psychotherapy [38] ) and the present intervention may produce even lower effects [8] . However, since the present intervention is low effort/cost in comparison to psychotherapy which takes weeks and is facilitated by a therapist who might not be easily available, we believe producing even a small effect is important and might be a good solution for people with no easy access to psychologists. Further, this study is about distress caused by the COVID-19 pandemic (largely due to fear of the possibility to contract the virus) and our advertising and the Plain Language Statement clearly refer to this source of distress. However, distress may have a variety of sources and not all might respond to writing or psychological interventions equally. The present study's results may therefore only apply to specific disaster-related distress scenarios. J o u r n a l P r e -p r o o f Inflammatory Bowel Disease Prevalence (IBD) in the United States: Centre for Disease Control and Prevention Bi-directionality of Brain-Gut Interactions in Patients With Inflammatory Bowel Disease Controversies Revisited: A Systematic Review of the Comorbidity of Depression and Anxiety with Inflammatory Bowel Diseases Views of patients with inflammatory bowel disease on the COVID-19 pandemic: a global survey COVID-19) RESPONSE 2020 COVID-19 Pandemic's Effects on Disease and Psychological Outcomes of People With Inflammatory Bowel Disease in Portugal: A Preliminary Research. Inflammatory bowel diseases Effect of psychological therapy on disease activity, psychological comorbidity, and quality of life in inflammatory bowel disease: a systematic review and meta-analysis. The lancet Gastroenterology & hepatology Experimental disclosure and its moderators: a meta-analysis The Effects of Expressive Writing Interventions for Patients With Cancer: A Meta-Analysis Expression of stressful experiences through writing: effects of a selfregulation manipulation for pessimists and optimists. Health psychology : official journal of the Division of Health Psychology Emotional expression and physical health: revising traumatic memories or fostering self-regulation? Journal of personality and social psychology Putting stress into words: health, linguistic, and therapeutic implications. Behaviour research and therapy Expressive writing and health: Self-regulation of emotion-related experience, physiology, and behavior Patterns of natural language use: Disclosure, personality, and social integration Examining the theory and clinical utility of writing about emotional experiences Confronting a traumatic event: toward an understanding of inhibition and disease Expressive writing is a promising therapeutic modality for the management of IBS: a pilot study Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations Does gratitude writing improve the mental health of psychotherapy clients? Evidence from a randomized controlled trial The role of resilience and gratitude in posttraumatic stress and growth following a campus shooting. Psychological trauma : theory, research, practice and policy High Levels of Psychological Resilience Associated With Less Disease Activity Initial Assessment of Post-traumatic Stress in a US Cohort of Inflammatory Bowel Disease Patients The role of psychological stress in inflammatory bowel disease: quality assessment of methods of 18 prospective studies and suggestions for future research A prospective populationbased study of triggers of symptomatic flares in IBD. The American journal of gastroenterology Writing About Emotional Experiences as a Therapeutic Process Symptoms of Depression and Anxiety Are Independently Associated With Clinical Recurrence of Inflammatory Bowel Disease. Clinical gastroenterology and hepatology : the official clinical practice journal of the Depression Is Associated With More Aggressive Inflammatory Bowel Disease Psychiatric comorbidity is associated with increased risk of surgery in Crohn's disease Psychosocial issues in evidence-based guidelines on inflammatory bowel diseases: a review Standards of healthcare for people with inflammatory bowel disease in Australia. Camberwell, VIC, Australia: Crohn's & Colitis Australia Do Inflammatory Bowel Disease patients with anxiety and depressive symptoms receive the care they need? Predictors of Impaired Mental Health and Support Seeking in Adults With Inflammatory Bowel Disease: An Online Survey. Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterology and motility : the official journal of the Are self-administered or minimal therapist contact psychotherapies an effective treatment for irritable bowel syndrome (IBS): a systematic review Psychological distress is highly prevalent in inflammatory bowel disease: A survey of psychological References Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity The Depression Anxiety Stress Scales-21 (DASS-21): further examination of dimensions, scale reliability, and correlates The Multidimensional Scale of Perceived Social Support Psychometric validity and the AQoL-8D multi attribute utility instrument The brief resilience scale: assessing the ability to bounce back Measures in health psychology: A user's portfolio Causal and control beliefs The study will be conducted using funding from the Deakin University Faculty of Health Mid-Career Fellowship 2020/21 and Janssen Australia Educational Grant 2020/21 awarded to Antonina Mikocka-Walus. The authors have no competing interests to report.