Work package 3a: internal pilot of 100 participants
Aim: To test planned methods and procedures for the main RCT and identify barriers to the components working together and potential recruitment issues.
Objectives:
- To train to competence at least five facilitators.
- To recruit and randomise the first 100 participants for the RCT, aiming to complete this within the first 12 months of the RCT recruitment.
- To identify likely recruitment rates and barriers to recruitment.
- To test recruitment and retention assumptions.
- To test the feasibility of completing the IBD-RUQ online (by assessing data quality and completion rate).
The methods planned for the main RCT were followed. The independent Programme Steering Group (PSG) pre-set progression criteria in advance, and these were judged to have been met. As no substantive changes were made, these 100 participants were included in the main RCT analysis, as approved by the PSG.
Work package 3b: randomised controlled trial
Aim: We aimed to recruit 740 participants using facilitator-supported online self-management of symptoms (fatigue, pain and faecal urgency/FI) compared with care as usual (CAU). Primary outcome: condition-specific IBD validated QoL and global assessment of symptom relief 6 months after randomisation. Secondary end points: validated symptom questionnaires and satisfaction with outcome (6 and 12 months). Online self-completion of outcome measures. Blinded intention to treat analysis comparing the two groups at 6 months.
The protocol for the RCT was published.
Paper 11: Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial17
Note: the sample size was subsequently adjusted from the initially proposed 680–740 to allow for coprimary end points. An update to the published protocol was published to reflect this.18
Paper 12: Digital cognitive behavioural self-management programme for fatigue, pain and faecal incontinence in inflammatory bowel disease: the IBD-BOOST randomised controlled trial19
This has also been presented as a poster at the European Crohn’s and Colitis Organisation meeting in Stockholm, 2024,20 and the British Society of Gastroenterology and United European Gastroenterology Week conferences as an oral poster, in 2024.
Ethical approval was granted by the London – Surrey REC (reference 19/LO/0750).
Some materials within this section have been reproduced with permission from Moss-Morris et al.19 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits others to copy and redistribute the material in any medium or format, provided the original work is properly cited. Material may not be used for commercial purposes. See: https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en. The text below includes minor additions and formatting changes to the original text.
Methods: The objective was to assess the effects of IBD-BOOST compared with CAU in relieving symptoms and improving QoL in people with IBD experiencing fatigue, pain and/or urgency/FI. A multicentre, two-arm, parallel-group RCT with computer-generated randomisation was conducted; 4449 patients with IBD who rated the impact of fatigue, pain and/or FI as ≥ 5/10 on a previous UK national survey were invited. The intervention was 6 months access to the online IBD-BOOST programme, and the control group received CAU. Primary outcomes were UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and Global Rating of Symptom Relief (GRSR) at 6 months post randomisation. More details on the RCT methods can be found in the published protocol.17
Key findings: Participants (N = 780) were randomised to the IBD-BOOST intervention (n = 391) or CAU (n = 389 (Figure 11). At 6 months, there were no statistically significant between-arm differences for UK-IBDQ {mean difference = −1.67 [95% confidence interval (CI) −4.17 to 0.83], p = 0.19; Figure 12} and GRSR [mean difference = 0.44 (95% CI −0.56 to 1.43), p = 0.39; Figure 13]. Complier-averaged causal effects (CACE) analysis demonstrated that participants who complied with the intervention reported better UK-IBDQ scores than ‘would-be’ compliers receiving CAU [mean difference = −2.36 (95% CI −4.44 to −0.28), p = 0.03]. Subgroup analyses did not identify any statistically significant treatment effect modifiers (Figures 14 and 15). Serious adverse events were similar between the intervention (n = 55, 14%) and CAU (n = 79, 20%).
FIGURE 11 The IBD-BOOST Consolidated Standards of Reporting Trials flow diagram. a, Some participants were not contacted at 12 months as follow-up was curtailed. Reproduced with permission from Moss-Morris et al.19 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits others to copy and redistribute the material in any medium or format, provided the original work is properly cited. Material may not be used for commercial purposes. See: https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
FIGURE 12 Arm-specific boxplots and half-violin plots of UK-IBDQ scores 6 and 12 months post randomisation. Reproduced with permission from Moss-Morris et al.19 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits others to copy and redistribute the material in any medium or format, provided the original work is properly cited. Material may not be used for commercial purposes. See: https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
FIGURE 13 Arm-specific boxplots of GRSR scores 6 and 12 months post randomisation.1 Reproduced with permission from Moss-Morris et al.19 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits others to copy and redistribute the material in any medium or format, provided the original work is properly cited. Material may not be used for commercial purposes. See: https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
FIGURE 14 Forest plot for subgroup analyses of Inflammatory Bowel Disease Questionnaire (condition-specific QoL measure) at 6 months post randomisation.19 IBS, irritable bowel syndrome; PHQ-9, Patient Health Questionnaire-9 items. Reproduced with permission from Moss-Morris et al.19 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits others to copy and redistribute the material in any medium or format, provided the original work is properly cited. Material may not be used for commercial purposes. See: https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
FIGURE 15 Forest plot for subgroup analyses of GRSR at 6 months post randomisation. IBS, irritable bowel syndrome; VSI, visceral sensitivity index. Reproduced with permission from Moss-Morris et al.19 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits others to copy and redistribute the material in any medium or format, provided the original work is properly cited. Material may not be used for commercial purposes. See: https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
Figure 16 shows a graphical abstract of these results.
FIGURE 16 Graphical abstract of the IBD-BOOST RCT. (Figure not reproduced here; see the original article.)
Conclusions: This large RCT showed that IBD-BOOST, a digital CB symptom-management programme, did not significantly improve disease-specific QoL or GRSR in IBD patients with fatigue, pain and/or urgency/FI compared to CAU alone. Secondary outcomes of FI and generic QoL (EuroQol-5 Dimensions) were improved in the IBD-BOOST group compared with CAU alone, but there was no difference in fatigue or pain scores. Improved disease-specific QoL was observed at 6 months in CACE analysis among participants who completed four or more intervention sessions.
Future work is needed to increase engagement with and adherence to IBD-BOOST, including the referral pathway, the amount of HCP support and who best to provide this support. The focus should be on those with higher levels of symptoms during remission. An expert commentary was published with the main RCT paper.45
Relation to the rest of the programme: IBD-BOOST did not improve disease-specific QoL or GRSR in IBD patients with fatigue, pain and/or urgency/FI compared to CAU. People who complied with the intervention appeared to derive benefit and improving compliance may be targeted in future. It was however, cost-effective within National Institute for Health and Care Excellence thresholds and participants valued the intervention (see below).
Work package 3c: health economics evaluation to determine cost-effectiveness from an NHS and personal perspective
Planned external publication (planned Paper 13): Economic evaluation of a digital behavioural self-management intervention for pain, fatigue and faecal incontinence in inflammatory bowel disease: the IBD-BOOST randomised controlled trial
Aim: To evaluate the cost-effectiveness of the IBD-BOOST intervention compared to CAU for people with IBD.
Methods: A cost–utility analysis was conducted alongside IBD-BOOST RCT in 780 people with IBD, from the health services and societal perspectives. The cost of the intervention, including intervention development, facilitators’ training and supervision and intervention updating, was assessed. Participants reported their health service use, out-of-pocket expenses, time off work over the previous 3 months and their health-related QoL at baseline, 6- and 12-month follow-up in the trial. Participants’ costs and quality-adjusted life-years (QALYs) over the 12 months were compared between study arms using mixed-effects models.
Key findings: The IBD-BOOST intervention resulted in additional per participant 0.016 QALYs (95% CI 0.002 to 0.030) over the 12 months in the study and cost savings of −£304.66 (−803.51; 194.18) for healthcare costs and −£39.48 (−388.09; 309.12) for out-of-pocket costs and time off work over months 3–6 and 9–12. This resulted in cost savings of −£28,633 (95% CI −51,555 to 18,764) and −£33,568 (−64,421; 26,198) per QALY gained with IBD-BOOST from health services and societal perspectives, respectively, and an indication of cost-effectiveness.
Conclusion: The IBD-BOOST intervention improves QALYs and is highly likely to be cost-effective for the self-management of pain, fatigue and FI in people with IBD.
Relation to other parts of the programme: The IBD-BOOST intervention resulted in additional QALYs, not statistically significant health care and other cost savings, and an indication of cost-effectiveness for IBD patients with fatigue, pain and/or urgency/FI compared to CAU.
Work package 3d: process evaluation
The RCT (above) found no difference in the primary end points of disease-specific QoL and GRSR compared with controls. Process evaluation is necessary to understand trial processes and outcomes. Further details of process evaluation data can be found in Report Supplementary Material 1.
Aim: The aim of our process evaluation was to describe and understand how the IBD-BOOST intervention was delivered, focusing on engagement, acceptability and intervention delivery and to explore explanations for trial outcomes.
Methods: Mixed-methods nested within the RCT, incorporating quantitative data for patient engagement and intervention fidelity, and qualitative interview data for patient and facilitator perspectives. These data are presented in two papers:
Paper 14: Process evaluation findings contradict RCT results of the IBD-BOOST digital self-management intervention for fatigue, pain and faecal urgency in inflammatory bowel disease: a mixed methods study of patient perspectives21
Some materials within this section have been reproduced with permission from Czuber-Dochan et al.21 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Methods: The online IBD-BOOST platform recorded participant and facilitator activity. Individual online interviews were recorded and transcribed verbatim. Four researchers and seven PPI members contributed to data coding and theme development; 30 participants were interviewed before randomisation and 28 after completion (12 from the intervention group and 16 from the CAU group).
Key findings: Typically, the time spent was less than the recommended session time, with the exception of Session 5: Managing stress and coping with emotions. The mean number of sessions participants completed was 5.0 (SD 4.0); 67 (17%) participants completed only 1 session, and 47 (12%) completed all 12 sessions; 221 (57%) participants completed our pre-defined ‘dose’ of 4 sessions (Report Supplementary Material 1).
Of the 346 participants who completed session 1, 306 (88%) completed their treatment phone call. The average call length was 34.3 minutes (SD 7.5). Participants received weekly messages through the IBD-BOOST programme facility, and facilitators adhered to this task with high fidelity (see facilitator paper below). The mean number of messages sent between participant and facilitator was 16.0 (SD 7.5) – participants sent between 5 and 23 messages to their facilitator (mean 5.3, SD 4.3).
Figure 17 lists the themes and subthemes from the participant interviews. Intervention group participants felt the IBD-BOOST intervention enhanced their symptom management and QoL, expressing high satisfaction with the programme’s structure and content; many continued to utilise the strategies post intervention. Results provide support for the programme’s acceptability and feasibility; the intervention was perceived to empower patients to manage their condition effectively while improving their well-being. Most participants found the content of the intervention highly relevant, addressing their specific needs and concerns related to their symptom management. They reported satisfaction with how the content of the programme provided recognition of commonly overlooked or misunderstood symptoms in IBD:
FIGURE 17 Themes and subthemes identified from participant interview data. CBI, Caregiver Burden Inventory. Reproduced with permission from Czuber-Dochan et al.21 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
I think even just the fact that this research is acknowledging fatigue as a symptom was the first step forward in IBD research.
Almost all CAU participants expressed willingness to start the programme after the RCT. None regretted being allocated to the control group, understanding this as a necessary RCT process.
Relation to the rest of the programme: The quantitative data suggest that many intervention participants did not engage with the online sessions as we had intended, either in time spent per session, or in total number of sessions completed. Combined with the CACE analysis (see RCT above), which suggested that those who received a ‘dose’ of four or more sessions did better, this suggests that measures to enhance engagement (such as more facilitator input) could achieve better results from IBD-BOOST).
Paper 15: Supporting patients using a digital self-management Intervention for symptoms of fatigue, pain, and urgency/incontinence in Inflammatory Bowel Disease: a mixed methods process evaluation of trial facilitators22
Aim: To evaluate facilitator adherence to intervention delivery and facilitator perspectives on training, intervention delivery and supervision during the trial and the future implementation enablers and barriers. Facilitators were trained (supported with a training manual) in the CB approach for IBD symptom management, the protocols for the treatment phone call, weekly in-programme messaging and trial procedures.
Methods: A randomised sample of 69 cases of intervention participant-facilitator in-programme messages were assessed using a bespoke fidelity assessment framework. Semistructured interviews were conducted with facilitators (n = 19), pre- (T1) and post-intervention delivery (T2) and were analysed using reflexive thematic analysis.
Key findings: Facilitators adhered to the trial protocol for intervention delivery and achieved a high level of fidelity for core message components. Assessing the message content for evidence of a CB approach, facilitators achieved a high level of competence, particularly conveying empathy and sensitivity, and in optimising engagement. Facilitators were less competent using a guided discovery approach. Qualitative interviews revealed that while some facilitators raised concerns about their ability to fulfil the role due to lack of a psychology background, all were positive about the overall training and felt well prepared for the role. Facilitator professional background did not affect competence. Four overarching themes and several subthemes, reflecting IBD-BOOST training and delivery, were identified (Table 7). Facilitators reported consistent support for the IBD-BOOST intervention programme and also expressed concerns about resource limitations encountered during the trial and cautioned that similar challenges could arise if the approach were implemented in routine NHS care.
| Themes | Subthemes |
|---|---|
| 1. Challenges, apprehensions and expectations of health professionals in the process of becoming facilitator | 1.1 Professional background and previous experience (T1)1.2 Pragmatics of facilitator training (T1)1.3 Expectations and apprehensions for becoming a facilitator (T1) |
| 2. The learning process led to a clearer understanding of the facilitator role | 2.1 The skills and hindrance in performing facilitator role (T1 and T2)2.2 The pragmatics of supervision (T2)2.3 A clearer picture of facilitator role in different aspects (T1 and T2) |
| 3. Recommendations for the intervention and its’ implementation | 3.1 The practicality of facilitator role in intervention (T2)3.2 Reflections and suggestions on the intervention design (T2)3.3 Reflections and suggestions on practical issues navigating the platform (T2)3.4 Suggestions on supervision (T2)3.5 Factors that may be considered for future implementation (T2) |
Relation to the rest of the programme: This process evaluation demonstrated that although the intervention trial outcomes were unsuccessful overall, this was not due to a lack of facilitator intervention fidelity or their level of support for the programme.
Additional work in work package 3
Study within a trial
Funded by MRC Prometheus study on trial methods (£5000). This enabled an additional randomisation and some data analysis. To determine if a short participant information leaflet (PIL) or a standard one influence recruitment and retention rates to the RCT.
Paper 16: PROMETHEUS in IBD-BOOST: What is the impact on recruitment of a brief compared with a standard participant information leaflet (PIL)? Study within a trial (SWAT)23
Some materials within this section have been reproduced with permission from Miller et al.23 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Aim: To evaluate the efficacy of a shortened PIL compared with a standard length PIL on trial recruitment and retention rates.
Methods: Two-arm SWAT was embedded in the host RCT (IBD-BOOST). Potential RCT participants were randomised to receive a standard length or shortened PIL electronically for recruitment to the host RCT. An Ethics Committee approved potential participants being blinded to this aspect of the research.
Key findings: 4201 participants were randomised to the standard length (n = 2099) and shortened (n = 2102) PIL arms (Figure 18); 34 e-mail queries were received about the PILs – 18 from those who received the standard version and 16 from those receiving the shortened version; 708 SWAT participants were recruited to the RCT – 333 (15.86%) who received the standard length PIL and 375 (17.84%) who received the shortened version [odds ratio 1.15 (95% CI = 0.98 to 1.35), p = 0.09]. Retention rates in the RCT were not statistically different between groups.
FIGURE 18 The Consolidated Standards of Reporting Trials flow chart for the SWAT. Reproduced with permission from Miller et al.23 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
Relation to the rest of the programme: RCT recruitment and retention rates were not statistically significantly different between participants randomised to the standard length PIL compared with the shortened. A shortened PIL may have the same effect on recruitment and retention outcomes, providing that the trial intervention does not require extensive information for other reasons (e.g. safety), and it did not generate more queries from potential participants.
Impact of coronavirus disease discovered in 2019 on participant engagement with inflammatory bowel disease-BOOST
Paper 17: The impact of COVID-19 on trial participants’ engagement with IBD-BOOST: a digital cognitive behavioural intervention24
Some materials within this section have been reproduced with permission from Honzlova et al.24 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for non-commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by-nc/4.0/. The text below includes minor additions and formatting changes to the original text.
The COVID-19 pandemic coincided with our RCT, and as part of our process evaluation, we thought it was important to know how this impacted engagement with our intervention.
Aims: To investigate how the pandemic affected engagement with the IBD-BOOST intervention.
Methods: Intervention participants were invited to complete an online survey after 6-month follow-up questionnaires were received. This included closed and open-ended questions. Quantitative and qualitative analyses were conducted.
Key findings: 171 (48.31% of intervention participants) completed the survey. Experiences of the pandemic’s impact on their engagement included both negative and positive impacts, as well as some who reported that the pandemic had no impact. Negative impacts (19.30% of respondents) included: the pandemic created additional work and home-life responsibilities, the pandemic-induced emotional and psychological burden contributed to decreased participation, and direct COVID-19 infection reduced engagement. Positive impacts (9.94%) included: increased time availability due to pandemic-induced lifestyle changes. Most felt the pandemic had no overall impact (50.29%) as adaptability helped to maintain their engagement. The other 20.47% of participants were uncertain, or reported that their involvement varied.
Relation to other parts of the programme: For some participants, the pandemic negatively impacted their engagement. However, 60% reported that the pandemic had either no impact or a positive impact on their engagement with IBD-BOOST, indicating the resilience of online delivery of behavioural interventions.
Patient Health Questionnaire-9 items risk assessment
Paper 18: Development and preliminary evaluation of a suicidal risk assessment protocol in a randomised controlled trial using the Patient Health Questionnaire (PHQ‑9)25
Some materials within this section have been reproduced with permission from Wileman et al.25 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Aim: The RCT participants may have expressed suicidal ideation on the PHQ-9 depression questionnaire (completed at baseline, 6- and 12-month follow-up), and we developed a risk assessment protocol to support participants at risk as we could find none in the literature.
Methods: Trial participants who expressed suicidal ideation on the PHQ-9 depression questionnaire at any stage in the trial were contacted and a risk assessment carried out. Trial research psychologists, who were not clinically responsible for at risk participants, contacted them by telephone and completed the risk assessment protocol. They then provided participants with support and guidance to appropriate professional services [NHS general practitioners (GPs), accident and emergency (A&E) and mental health charities Mind and Samaritans]. The risk assessment was not repeated for participants who expressed suicidal ideation more than once, as the protocol was intended to assess at the first occurrence of their disclosure and triage to professional support.
Key findings: There were 58 risk alerts during the RCT, 41 of which were new alerts and required risk assessment. All were assessed as low risk or medium risk; none were high risk. We produced a revised version with minor refinements based on our experiences. The risk assessment protocol is freely available via our IBD-BOOST website: www.kcl.ac.uk/assets/research/pdf/ibd-boost-phq-9-risk-assessment-protocol.pdf (accessed 10 September 2025) (Figure 19).
FIGURE 19 Risk assessment protocol evaluated in the IBD-BOOST trial. Q, question. Reproduced with permission from Wileman et al.25 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
Relation to other parts of the programme: This risk assessment was used throughout the RCT.
Paper was presented as a poster at the European Crohn’s and Colitis Conference 2024.
Additional analysis of baseline data from the randomised controlled trial
Paper 19: Modifiable psychological factors are associated with symptom clusters of pain, fatigue and faecal incontinence in inflammatory bowel disease: a latent profile analysis26
Some materials within this section have been reproduced with permission from Wileman et al.26 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Methods: This study was nested within the RCT. Latent profile analysis (LPA) was conducted on pre-randomisation baseline measures of fatigue, pain and FI. Multinominal logistic regression examined associations between profile membership and clinical, demographic and psychological factors.
Results: A three-profile model was indicated by LPA: moderate (50%), high (40%) and severe symptoms (10%) (Figure 20). Diagnosis (CD vs. UC) and inflammation (FCP) were not associated with profile membership, but female gender, comorbidity, time since diagnosis and irritable bowel syndrome (IBS)-type symptoms were associated with High and Severe symptoms profiles. Depression, anxiety, negative symptom perceptions, all-or-nothing and avoidance behaviours significantly increased the relative risk of High and Severe symptom profiles.
FIGURE 20 Associated risk factors for symptom severity profile group. BIPQ, Brief Illness Perception Questionnaire; CBRQ, Cognitive Behavioural Responses to Symptoms Questionnaire; SEMCD6, Self-Efficacy for Managing Chronic Disease 6-item Scale; VSI, visceral sensitivity index. Reproduced with permission from Wileman et al.26 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original text. (Figure not reproduced here; see the original article.)
Conclusions: After controlling for clinical, inflammatory and demographic factors, the relative risk of High or Severe symptom profile membership was associated with potentially modifiable CB factors. These factors were also associated with IBS-type symptoms. Recognising the potential impact of CB factors in exacerbating symptoms could lead to earlier identification of patients who require support and allows treatment plans to be tailored more precisely. The findings from this study promote a more integrated approach to IBD management, combining medical treatment with CB interventions to enhance patient care and improve outcomes.
Relation to other parts of the programme: 50% of trial participants experienced High or Severe levels of symptoms across all three symptoms of fatigue, pain and FI. After controlling for clinical and inflammatory factors, the relative risk of High or Severe symptom profile membership was associated with modifiable psychosocial factors, suggesting behavioural methods may be appropriate to lessen the severity of symptom burden experienced in this group.
Paper 20: The relationships between depression, inflammation and self-reported IBD activity and their impact on healthcare usage27
Some materials within this section have been reproduced with permission from Seaton et al.27 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Also presented at the European Health Psychology Society meeting in Portugal September 2024.
Background: Depression is common in people living with IBD. Depression rates increase with active disease and are linked to poorer clinical outcomes. Previous studies investigating the relationship between contemporaneous IBD disease activity and depression are often poorly controlled, use small samples and/or rely on self-reported measures of disease activity. Depression and self-reported disease activity (SRDA) are linked to increased healthcare usage. However, objective inflammation is rarely statistically controlled. The primary aim was to understand how SRDA and inflammation are related to depression. Secondary aims included assessing the relative influence of SRDA, inflammation and depression on healthcare usage.
Methods: This was a cross-sectional analysis of some of the baseline data collected as part of the RCT (above) (n = 599). Bivariate associations of demographic and clinical variables with depression were conducted to identify relevant covariates. Multiple linear regressions assessed (1) the relationships between depression (PHQ-9), SRDA (IBD-Control) and intestinal inflammation (FCP) and (2) whether these variables explained variance in healthcare usage and economic indicators.
Results: Depression was significantly predicted by SRDA (β = −0.82, p < 0.001), but not FCP, with the model explaining 37% of the variance in depression [F(2596) = 175.1, p < 0.001]. FCP was only weakly associated with SRDA (r = −0.16, p < 0.001). Depression was independently associated with visits to primary care (β = 0.19, p < 0.001), IBD secondary care (β = 0.13, p < 0.001), IBD-related A&E attendance (β = 0.10, p < 0.05) and the impact of IBD on productivity (β = 0.24, p < 0.001) in the last 3 months.
Conclusions: Depression was related to SRDA but not FCP. Depression was also associated with healthcare usage even when SRDA and inflammation were statistically controlled. Routinely assessing and treating depression in IBD alongside managing inflammation may improve symptoms for patients and reduce healthcare costs.
Relation to other parts of the programme: Though depression is not significantly related to FCP, it was a relevant factor for healthcare usage even when self-report control and inflammation are statistically controlled. IBD services should consider mental and physical health factors to optimise resource allocation and should work to treat depression as this may inflate costs.