Inflammatory bowel disease (IBD) considerably impacts the quality of life and raises the risk of developing mental health problems (Knowles et al., 2018). People with IBD have a higher prevalence of anxiety and depression than the general population (Barberio et al., 2021). Depression can increase IBD symptoms through the production of proinflammatory (Taché and Bernstein, 2009), which may itself increase levels of depressive symptoms (Keefer and Kane, 2017). In conjunction with medical care, psychological therapies might have beneficial effects on disease activity, mental health, and quality of life in people with IBD (Paulides et al., 2021).

Third-wave cognitive and behavioural therapies (CBT) (e.g., Mindfulness-Based Interventions, Acceptance and Commitment Therapy [ACT], and Compassion Focused Therapy [CFT]). have been suggested as particularly pertinent in populations with illness (Graham et al., 2016; Ferreira et al., 2018; Trindade et al., 2018). ACT intends to increase psychological flexibility through acceptance- and mindfulness-promoting techniques that increase willingness to go through adverse internal experiences (e.g., thoughts, feelings, sensations) while engaging with commitment in actions that promote a valued and meaningful life (Hayes et al., 2011).

Recent findings have highlighted that ACT-based interventions seem to be efficacious in reducing symptoms of stress (Lavelle et al., 2022), depression and anxiety (Romano et al., 2023) as well as feasible and well-accepted by adults living with IBD (Dober et al., 2021; Lavelle et al., 2022; Romano et al., 2023). Although these studies present limitations that limit the generalizability of results (e.g., small sample sizes) (Lavelle et al., 2022), they highlight the need for further research and replication (for example, through a full-scale randomized controlled trial) to further assess the efficacy of ACT-based interventions within the scope of IBD (Romano et al., 2023). To our knowledge, only two Randomized Controlled Trials (RCT) on ACT interventions have been performed in this population. These trials showed improvements in stress (Rowan et al., 2017; Wynne et al., 2019), depression, and general well-being (Wynne et al., 2019) compared to a control group.

Mindfulness-based interventions that aim to promote present-moment awareness and a non-judgmental attitude towards internal experiences have been tested in the context of IBD (Ewais et al., 2019). Mindfulness-Based Stress Reduction (MBSR) interventions have been shown to increase the quality of life (Jedel et al., 2014; Goren et al., 2022) and reduce psychological symptoms (Drent et al., 2016; Goren et al., 2022), fatigue (Goren et al., 2022), and the concentration of C-reactive Protein (CRP) and faecal calprotectin in IBD (Berrill et al., 2014; Gonzalez-Moret et al., 2020).

Compassion-focused therapy addresses aspects such as shame, stigma and self-criticism, which are often reported by people with IBD and influence their psychosocial functioning (Taft et al., 2017; Trindade et al., 2020a). Self-compassion, defined as the sensitivity and the desire to alleviate one’s suffering and the ability to extend kindness and understanding towards the self when facing personal setbacks or inadequacies, has been shown to have a protective effect against psychological distress in IBD (Trindade and Sirois, 2021). The integration of compassion-based components in psychological interventions in this population may thus be beneficial and has been proven effective in other chronic conditions (Brown et al., 2019; Gooding et al., 2020).

Previous studies that tested the efficacy of integrative programs based on self-compassion components, ACT and mindfulness-based in chronic health conditions appear to be feasible and efficacious in improving quality of life, mental health, psychological flexibility, or shame (Skinta et al., 2015; Trindade et al., 2020b). Nonetheless, this kind of integrative interventions have yet to be tested in IBD.

The present RCT tests the acceptability and preliminary efficacy of a face-to-face intervention tailored for IBD patients, the “Living with Intention, Fullness, and Engagement with Inflammatory Bowel Disease” intervention (Trindade et al., 2021), in comparison with a waitlist control condition (“psychological treatment as usual” in Portugal). This study’s main research questions relate to whether the LIFEwithIBD intervention presents acceptability among participants and efficacy in improving psychological distress when compared to the control condition. It is expected that the LIFEwithIBD intervention will be well-accepted by participants and will lead to decreases in anxiety and depression, over the ones that might be reported by the control group.

The present study aimed to investigate the acceptability and preliminary efficacy of a face-to-face, group ACT and compassion-based intervention for people with IBD (LIFEwithIBD) through a two-arm RCT. The results for the intervention acceptability were encouraging, as most participants reported a high level of satisfaction with the intervention and considered it useful. Specifically, all participants stated that participating in the intervention was worthwhile and would recommend it to other people with IBD. These results align with the high acceptability presented by previous studies on ACT and compassion-based interventions in chronic illness populations (Trindade et al., 2020b; Dober et al., 2021; Romano et al., 2023). Patients may particularly well accept these third-wave CBT approaches due to their focus on universal psychological processes rather than on symptoms, which may help decrease stigma around the disease and participation in psychotherapy.

No significant differences in depression, anxiety, and stress were found between the EG and the CG. A possible floor effect due to generally low levels of psychological distress at baseline may explain these results [most participants scored below the DASS-21 cut-offs for moderate depression or anxiety (Lovibond, 1995)]. There may not have been enough room for significant improvement, as would have been the case if participants had started at higher levels of psychological distress. From baseline to post-treatment, the EG experienced a significant reduction in symptoms of anxiety and stress, but this effect did not persist during the follow-up periods. This suggests that including booster sessions following the LIFEwithIBD intervention could potentially help maintain the benefits of the intervention. There is evidence that interventions with booster sessions provide better results at follow-up than those without sessions following the main interventional period (Gearing et al., 2013; Wesner et al., 2015). Alternatively, there might also be room for other types of follow-up material like bibliotherapy or online support. In IBS, for example, Ferreira et al. (2018) used an ACT-based self-help manual to support practice in the long-term with positive gains in outcomes obtained from the intervention being sustained at 6 months follow-up.

Moreover, there were no significant differences between groups concerning secondary outcomes (functional impairment, general and health-related quality of life, chronic illness-related shame, IBD symptoms, self-compassion, and psychological flexibility). These unexpected results suggest that the LIFEwithIBD intervention did not influence these outcomes. This, again, may be linked to the low levels of psychological distress at baseline. A significant decrease in stress symptoms and IBD symptom perception was found over time, but there were no differences between groups in this outcome.

The intervention presented effects on disease activity in participants with Crohn’s Disease but not for participants with ulcerative colitis. Participants with Crohn’s Disease from the EG reported significantly lower Harvey-Bradshaw scores at the first follow-up compared to the CG. Only one study using the Harvey-Bradshaw score as an outcome in a psychological intervention trial has found a similar pattern of reduction in symptoms after a CBT and mindfulness-based intervention (Goren et al., 2022).

To determine if the subset of our participants with higher psychological distress particularly benefited from the LIFEwithIBD intervention, we performed a post hoc analysis considering mild to severe DASS-21 scores as contributing factors to the response to the intervention. No between-group differences were observed in depression or stress symptoms at post-treatment after adjusting for baseline symptom scores. A significant difference between groups in anxiety symptoms was observed at post-treatment, with the EG reporting a larger reduction in symptoms than the CG. This result should be interpreted considering two points. First, the LIFEwithIBD intervention does seem effective for reducing psychological distress, but since most participants presented lower levels of distress at baseline, the results did not reach statistical significance. Second, in a post hoc analysis, limiting the sample size reduces the statistical power, and only the largest effect sizes are detected. Regarding primary outcomes, depression is near to reaching statistical significance (p = 0.08). Further investigation is needed regarding the use of this intervention, particularly in patients who are likely to experience comorbid psychological distress.

In addition to the psychological self-reported evaluation, inflammatory biomarkers were assessed. The serum albumin results were unsurprising since this plasma protein tends to decrease quickly in severely ill patients. All participants in this study were under clinical remission, and, as expected, serum albumin remained within the reference interval in all participants from CG and EG, both at baseline and T3. The same rationale holds true for CRP and faecal calprotectin. Our results showed no significant differences regarding both biomarkers between the CG and EG at T3. Similarly, no differences were observed in the total blood count of participants. These results suggest that, from a bioanalytical point of view, disease activity in our sample remained under control throughout the study. The question remains as to whether the LIFEwithIBD intervention could have an impact on gut microbiota phenotype. Indeed, it would be interesting to characterize the gut microbiota of these patients before and after the intervention to ascertain if the modulation of the microbiota-gut-brain axis could be the mechanism underlying the impact of the treatment on psychological (dis)tress herein observed since similar reports have been made regarding IBS (Halkjær et al., 2018).

Overall, these findings need to be interpreted considering several limitations. Due to this study’s relatively small sample size, further studies are required to test the efficacy of the LIFEwithIBD intervention in larger samples. Similarly to previous RCTs testing group interventions in the IBD context (Mikocka-Walus et al., 2017; Wynne et al., 2019), the study showed a considerable attrition rate. This may be due to the time commitment needed to participate in the intervention, combined with the simultaneous management of different life contexts, the lack of monetary compensation for participating in the study, and the lack of transportation to attend the intervention (most screened patients lived outside Coimbra, in the suburbs or in other cities in Portugal). Furthermore, the stigma associated with mental health still present in Portuguese society, which is regarded as one of the main barriers to access to psychological treatment in Portugal (Palha and Palha, 2016), may have also contributed to the study’s limited enrolment rate. Participants from both groups did not indeed present levels of psychological distress, which might have reduced the sensitivity to changes in the outcome measures. This is suggestive that including patients with higher psychological distress (rather than this being an exclusion criterion, such as in the present study) could be of interest in future studies testing the LIFEwithIBD intervention. Another limitation of this study was the use of self-report questionnaires. Although the efficacy of psychological interventions is often assessed through self-assessment, critics believe that the evaluation and interpretation of treatment efficacy can be impaired by the occurrence of a “response shift,” which could contaminate (reduce or amplify) treatment effects. Also, our findings revealed minor changes in anxiety and stress symptoms that may be interpreted as collateral, since the purpose of ACT, mindfulness and self-compassion-based therapies is to improve quality of life, which in our study was considered a secondary outcome which did not show any change. Furthermore, self-report measures that are not very close to each person’s reality may compromise the results, as these measures may not be sensitive to change. For example, in a study conducted in a sample of patients with fibromyalgia, it was found that the most sensitive instrument to the effects of the intervention was the self-report of longitudinal experiences based on questions about the participants’ daily lives in several weeks before and after of the intervention (de la Coba et al., 2022). Further studies should integrate qualitative methods to complement the assessment of intervention efficacy. Finally, although the EG and CG presented similar demographic characteristics, they presented differences in important outcomes at baseline (EG presented a higher level of self-critical attitude and lower levels of psychological flexibility, which may have influenced results). Furthermore, it is important to consider the circumstances under which the study’s assessments occurred. The post-treatment assessment and the second follow-up coincided with two periods of lockdown in Portugal due to the COVID-19 pandemic. It is difficult to hypothesize their possible effects on this study, as studies show that the effects of lockdown periods on mental health are not the same for each individual (Prati and Mancini, 2021).

Despite these limitations, this is the first study to investigate the preliminary efficacy of psychological and disease outcomes and biomarkers of an integrative face-to-face ACT and compassion-based intervention in the context of IBD. Preliminary findings suggest that the LIFEwithIBD intervention may be better suited for IBD patients presenting with high levels of psychological distress. Given that these patients are more likely to self-exclude from these interventions, future studies should address ways of engaging these patients. One possibility would be the use of non-face-to-face approaches such as online interventions. Further research is needed to reach more comprehensive conclusions.

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

This study was approved by Ethics Committee of the Coimbra University Hospital (CHUC). It was conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.

CF: Conceptualization, Data curation, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – original draft. JP: Data curation, Investigation, Methodology, Resources, Writing – original draft. DS: Conceptualization, Formal analysis, Writing – original draft. SO: Data curation, Investigation, Methodology, Resources, Writing – review & editing. AG: Investigation, Writing – review & editing. NF: Conceptualization, Validation, Writing – review & editing. PL-S: Writing – review & editing. SC: Validation, Writing – review & editing. IM-P: Data curation, Investigation, Writing – review & editing. BR: Data curation, Formal analysis, Investigation, Methodology, Writing – review & editing. FP: Conceptualization, Investigation, Methodology, Resources, Validation, Writing – review & editing. IT: Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing.