To Örebro University

BACKGROUND: Breast cancer is the most diagnosed cancer in women worldwide and carries a considerable psychosocial burden. Interventions based on Acceptance and Commitment Therapy (ACT) and compassion-based approaches show promise in improving adjustment and quality of life in people with cancer. The Mind programme is an integrative ACT and compassion-based intervention tailored for women with breast cancer, which aims to prepare women for survivorship by promoting psychological flexibility and self-compassion. A pilot study of the Mind programme has shown acceptability and preliminary efficacy in improving quality of life and psychological health. This paper presents the study protocol of two randomised controlled trials that aim to test the efficacy and cost-effectiveness of an optimised version of the Mind programme in women with breast cancer.

METHODS: Participants will be women diagnosed with breast cancer randomly assigned to the Mind programme or a support group intervention (active control) in a 1:1 ratio for study 1, while study 2 includes one more arm (treatment as usual; inactive control) and a 2:2:1 ratio. Both interventions will be delivered weekly via an 8-session face-to-face or online group format. Data will be collected at baseline, post-treatment and 6-month follow-up. The efficacy and cost-effectiveness of the two interventions will be assessed. Treatment outcomes will comprise cancer-specific quality of life (primary outcome), anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related quality of life, resource use, and intervention's acceptability and feasibility. Study 1 will also include immunological and epigenetic markers associated with breast cancer prognosis and mental health. Outcome assessors will be blind to group allocation. Statistical analyses will be conducted using an intention-to-treat approach. Analyses of moderators and mediators of change will also be performed.

DISCUSSION: These trials examine the efficacy and cost-effectiveness of an integrative ACT and compassion-based intervention tailored for women with breast cancer. Greater improvements in psychosocial, biological and resource use are expected in the Mind group, when compared to the control group(s). Results will likely support the potential benefits of the Mind programme for breast cancer patients and highlight the clinical relevance of integrative and holistic interventions in oncology.

TRIALS REGISTRATION {2A, 2B}: ClinicalTrials.gov NCT05642897 and NCT06212414. Registered on December 8, 2022, and January 18, 2024.

BACKGROUND: Gut-directed hypnotherapy is effective for irritable bowel syndrome (IBS) and a few studies have reported long-lasting therapeutic effects following intervention. No previous studies have evaluated the long-term effects of nurse-administered hypnotherapy.

AIMS: We aimed to investigate the long-term effects of nurse-administered gut-directed hypnotherapy for IBS and identify factors associated with symptom improvement. Furthermore, we aimed to compare treatment effects between individual and group hypnotherapy.

METHODS: A 2-year follow-up study including 289 patients with IBS who had completed a 12-week hypnotherapy program (individually or in groups) was conducted. Data were collected at baseline, and at 6-month-, 1-year- and 2-year follow-ups. Irritable bowel syndrome and extracolonic symptom severity (IBS-SSS), gastrointestinal-specific anxiety (VSI), and anxiety and depressive symptoms (HADS) were assessed. Patients reporting a reduction ≥ 50 points (IBS-SSS) were classified as treatment responders.

RESULTS: The 2-year follow-up was completed by 207 patients. The proportion of responders at post-treatment was 64.3%, 62.8% at the 6-month follow-up, 64.7% at the 1-year follow-up, and 61.8% at the 2-year follow-up. The severity of IBS symptoms, extracolonic and psychological symptoms were all reduced post-treatment, and this effect lasted over the 2-year follow-up period (p < 0.001). Younger age, individual hypnotherapy, and severe irritable bowel syndrome symptoms at baseline predicted a better response to treatment (R2 = 0.16).

CONCLUSIONS: Nurse-administered gut-directed hypnotherapy is an effective treatment for IBS with long-lasting symptom improvements. Younger age, severe irritable bowel syndrome symptoms, and individual treatment might be important factors associated with effectiveness (ClinicalTrials.gov study protocol IDs: NCT06167018, NCT03432078).

TRIAL REGISTRATION: ClinicalTrials.gov study protocol IDs: NCT06167018, NCT03432078.

BACKGROUND: Brain-gut behaviour therapies (BGBT) have gained widespread acceptance as therapeutic modalities for the management of disorders of gut-brain interaction (DGBI). However, existing treatment evaluation methods in the medical field fail to capture the specific elements of scientific rigour unique to behavioural trial evaluation.

AIMS: To offer the first consensus on the development and testing of BGBT in DGBI.

METHODS: An international, interdisciplinary team of experts developed a consensus statement heavily informed by best practice recommendations for behavioural clinical trials for chronic diseases, organised by a selected treatment development model.

RESULTS: We suggest an existing behavioural treatment development model that has an iterative progression aligned with the drug development model with nuances specific to BGBT. We describe the iterative phases through initial discovery and experimental work, assembly of a mechanistic pathway and candidate treatment components, treatment refinement and optimisation, initial proof-of-concept, feasibility of clinical trials and, finally, confirmatory efficacy and effectiveness testing. We delineate recommendations for and provide examples that lend themselves to gastroenterologists planning to develop or test BGBT, reviewing proposals for or results from BGBT studies or writing management guidelines for DGBI.

CONCLUSIONS: This working team report facilitates a shared understanding of the elements of scientific rigour necessary for BGBT development and could support future standards on which BGBT are evaluated in gastroenterology.

Background: Inflammatory bowel disease (IBD) entails physical, psychological, and social burden and holds a significant impact on quality of life. Experiential avoidance, cognitive fusion, shame, and self-criticism have been identified as possible therapeutic targets for improving mental health in people with IBD. Traditional face-to-face psychological therapy continues to provide obstacles for patients seeking assistance. Online psychological therapies centered on acceptance, mindfulness, and compassion have been shown to improve psychological distress in other populations.

Objective: This paper presents the study protocol of a two-arm Randomized Controlled Trial (RCT) of an ACT and compassion-based, online intervention –eLIFEwithIBD - on the improvement of psychological distress, quality of life, work and social functioning, IBD symptom perception, illness-related shame, psychological flexibility, and self-compassion.

Methods: The eLIFEwithIBD intervention is an adaptation of the LIFEwithIBD programme (delivered through an in-person group format) and entails an ACT, mindfulness, and compassion-based intervention designed to be delivered as an e-health tool for people with IBD. This protocol outlines the structure and contents of the eLIFEwithIBD intervention. Participants were recruited by an advertisement on the social media platforms of Portuguese Associations for IBD in January 2022. A psychologist conducted a brief interview with 80 patients who were interested in participating. Fifty-five participants were selected and randomly assigned to one of two conditions [experimental group (eLIFEwithIBD + medical TAU; n = 37) or control group (medical TAU;n = 18)]. Outcome measurement took place at baseline, post-intervention, and 4-month follow-up. All analyses are planned as intent-to-treat (ITT).

Results: The eLIFEwithIBD intervention is expected to empower people with IBD by fostering psychological strategies that promote illness adjustment and well-being and prevent subsequent distress. The eLIFEwithIBD aims to gain a novel and better understanding of the role of online contextual behavioral interventions on improving the quality of life and mental health of people with IBD.

Clinical Trial Registration: https://classic.clinicaltrials.gov/ct2/show/NCT05405855, NCT05405855.

INTRODUCTION: This study focused on defining the global prevalence of clinically relevant levels of psychological distress and somatic symptoms and the prevalence of coexistence between these symptoms and disorders of gut-brain interaction (DGBI). We also analyzed how clinically relevant psychological distress and somatic symptoms and coexistent DGBI are associated with health-related outcomes.

METHODS: We included a representative sample of 54,127 adult participants (49.1% women; mean age of 44.3 years) from 26 countries worldwide. Participants completed an Internet survey (the Rome Foundation Global Epidemiology Study) with validated self-report questionnaires.

RESULTS: Clinically relevant psychological distress and/or somatic symptom severity was reported by 37.5% of the sample. These participants had 4.45 times higher odds to have at least one DGBI than individuals without psychological distress and/or somatic symptoms. Compared with participants with psychological distress and/or somatic symptoms with vs without DGBI, participants with a DGBI reported increased healthcare and medication utilization (with OR from 1.6 to 2.8). Coexistent DGBI in participants with psychological distress and/or somatic symptoms was the variable most strongly associated with reduced mental (β = −0.77; confidence interval [−0.86 to −0.68]) and physical (β = −1.17; confidence interval [−1.24 to −1.10]) quality of life.

DISCUSSION: This global study shows that psychological distress, somatic symptoms, and DGBI are very common and frequently overlap. The coexistence between psychological distress/somatic symptoms and DGBI seems to be especially detrimental to quality of life and healthcare utilization. Individuals with psychological distress/somatic symptoms and DGBI coexistence seem to be a group vulnerable to psychosocial problems that should be studied further and would likely benefit from psychological/psychiatric interventions.

Individuals with chronic illnesses and those infected with SARS-CoV-2 often face stigma, shame, and psychological distress related to their conditions. Higher psychological flexibility and self-compassion are often associated with less stigma and shame. Examining and comparing these experiences between people with chronic illness and people who have recovered from SARS-CoV-2 can provide valuable insights into the shared and unique challenges they encounter. This study aimed to compare these two groups, and used structural equation modelling to investigate the links between stigma, shame, and psychological distress, with a focus on the mediating roles of psychological flexibility and self-compassion in these associations. The study included 270 Portuguese participants (chronic illness: n = 104; SARS-CoV-2: n = 166), with an average age of 36.73 years and 86.6% of the sample being women. Results showed that the chronic illness subgroup reported higher levels of illness stigma, anxiety, and depression, compared to the SARS-CoV-2 subgroup. Findings from the mediation analysis, revealed that the model fit exceptionally well, accounting for 48% of the variance in anxiety and 45% in depression symptoms across the entire sample. Most parameters were consistent between the two subgroups, except for the association between self-compassion and depression symptoms, which was only statistically significant in the chronic illness subgroup. In this group, both psychological flexibility and self-compassion mediated the association between stigma and shame with symptoms of anxiety and depression. In the SARS-CoV-2 subgroup, these processes mediated the association with anxiety, whereas psychological flexibility only mediated depression symptoms. The findings from this study provide directions for future research on the possible development or refinement of personalized psychological interventions targeting emotional distress in adults with chronic illnesses and viral disease recovery cohorts.

INTRODUCTION: The COVID-19 pandemic held considerable health-related outcomes worldwide, including mental health challenges, with elevated risk of psychiatric sequelae.

METHODS: This study aimed to test the longitudinal (1 year) predictive role of psychosocial factors on post-traumatic stress disorder (PTSD), anxiety, and depressive symptoms in SARS-CoV-2 survivors (N = 209 at T1; N = 61; attrition rate 70.83%), through Pearson's correlation analyses and longitudinal multiple regression analyses. Participants (age M = 35.4, SD = 10.1) completed online self-report questionnaires of psychosocial variables, PTSD, anxiety, and depression.

RESULTS: Depression and anxiety symptoms were increased, and 42% of survivors presented clinically meaningful PTSD symptoms. PTSD symptoms were longitudinally predicted by having children (β = 0.32, p < 0.01), number of recent major life events (β = 0.34, p < 0.01), and psychological flexibility (β = -0.36, p < 0.01). Number of major life events (β = 0.29, p < 0.05) and psychological flexibility (β = -0.29, p < 0.05) predicted anxiety. Number of recent major life events (β = 0.32, p < 0.01) was the sole predictor of depressive symptoms.

DISCUSSION: Psychosocial variables contribute to the long-term harmful effects of the COVID-19 pandemic on psychopathological symptoms. These results suggest that, during the pandemic, mental health was impacted by both socio-contextual factors and individual self-regulatory skills, namely the ability to respond flexibily to contextual cues and guide behavior according to the direct experience. Specifically, results point out the importance of societal incentives to reduce parental burden and socioeconomic losses, as well as to promote adaptive psychological skills such as psychological flexibility.

Objectives: This study tested the acceptability and efficacy of an Acceptance and Commitment Therapy and compassion-based intervention (LIFEwithIBD) in people with IBD through a two-arm RCT.

Methods: Participants were recruited at the Gastroenterology Department of the Coimbra University Hospital between June and September 2019. Of the 355 patients screened, those who accepted to participate were randomly assigned to one of two conditions: experimental group (LIFEwithIBD; n = 25) or control group (waitlist; n = 29). Participants completed self-report measures at baseline (T0), post-intervention (T1), and 3-month (T2) and 12-month (T3) follow-ups. Intervention acceptability was assessed. Efficacy was examined using intent-to-treat ANCOVA at post-intervention after adjusting for baseline values of depressive, anxiety, and stress symptoms (primary outcomes). Linear mixed models for all longitudinal outcomes were also analysed. Inflammatory and disease biomarkers were determined at T0 and T3.

Results: Acceptability results revealed a high level of satisfaction and perceived usefulness regarding the intervention. Both groups experienced a significant decrease in stress symptoms and IBD symptom perception at T1. No significant differences were observed at follow-up for the primary outcomes. The experimental group reported significantly lower Crohn’s disease Symptom severity at T2 than the control group. Post-hoc analyses designed to mitigate floor effects revealed substantial treatment effects for the experimental group regarding anxiety symptoms. No significant differences were observed in clinical biomarkers from T0 to T3.

Conclusion: The LIFEwithIBD intervention shows promising, although preliminary, benefits for managing disease activity and reducing anxiety symptoms in IBD patients with high severity of psychological distress.