Randomised clinical trial: Psychological intervention improves work productivity and daily activity by reducing abdominal pain and fatigue in Crohn's disease.

BACKGROUND: Chronic abdominal pain and fatigue are characteristics of Crohn's disease (CD) and contribute to functional impairments. AIMS: To examine whether CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) is effective in reducing abdominal pain and fatigue in patients with CD and whether changes in abdominal pain and fatigue mediate any beneficial effects of COBMINDEX on impairments in work productivity and daily activities. METHODS: This is a secondary analysis of a parallel-group multicentre randomised controlled trial. Patients with mild-to-moderate CD (n = 142) were randomised into either intervention group receiving COBMINDEX, or control group receiving treatment-as-usual for 3 months followed by COBMINDEX. Complete data were collected from 120 patients (34.0 ± 10.7 years, 62.5% female, intervention = 60, control = 60). Analysis of covariance assessed group differences in 3-month follow-up scores, controlling for baseline scores. Multiple parallel mediation analysis assessed the proposed mechanisms for the entire sample. RESULTS: The intervention group demonstrated significantly lower levels of abdominal pain (F = 17.46, p < 0.001, η2 p  = 0.13), fatigue (F = 7.26, p = 0.008, η2 p  = 0.06) and impairments at work (F = 4.82, p = 0.032, η2 p  = 0.07) and daily activities (F = 6.26, p = 0.014, η2 p  = 0.05), compared with treatment-as-usual. Moreover, changes in abdominal pain and fatigue significantly mediated the beneficial effects of COBMINDEX on patients' work productivity (b = -9.90, SE = 2.86, 95% CI: -16.11 to -4.94) and daily activities (b = -9.65, SE = 1.91, 95% CI: -13.77 to 6.35), independent of changes in disease activity. CONCLUSIONS: COBMINDEX is effective at reducing abdominal pain and fatigue in patients with CD, which in turn leads to improvement in functioning. Clinicians should incorporate screening for severe abdominal pain and fatigue and consider offering cognitive-behavioural and mindfulness training. CLINICALTRIALS: gov, Number: NCT05085925. Ministry of Health in Israel (https://my.health.gov.il/CliniTrials/Pages/MOH_2020-02-24_008721.aspx).

Brain-immune axis regulation is responsive to cognitive behavioral therapy and mindfulness intervention: Observations from a randomized controlled trial in patients with Crohn's disease.

BACKGROUND AND AIMS: Crohn's disease (CD) is a chronic inflammatory bowel disease associated with psychological stress that is regulated primarily by the hypothalamus-pituitary-adrenal (HPA) axis. Here, we determined whether the psychological characteristics of CD patients associate with their inflammatory state, and whether a 3-month trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) impacts their inflammatory process. METHODS: Circulating inflammatory markers and a wide range of psychological parameters related to stress and well-being were measured in CD patients before and after COBMINDEX. Inflammatory markers in CD patients were also compared to age- and sex-matched healthy controls (HCs). RESULTS: CD patients exhibited increased peripheral low-grade inflammation compared with HCs, demonstrated by interconnected inflammatory modules represented by IL-6, TNFα, IL-17, MCP-1 and IL-18. Notably, higher IL-18 levels correlated with higher score of stress and a lower score of wellbeing in CD patients. COBMINDEX was accompanied by changes in inflammatory markers that coincided with changes in cortisol: changes in serum levels of cortisol correlated positively with those of IL-10 and IFNα and negatively with those of MCP-1. Furthermore, inflammatory markers of CD patients at baseline predicted COBMINDEX efficacy, as higher levels of distinct cytokines and cortisol at baseline, correlated negatively with changes in disease activity (by Harvey-Bradshaw Index) and psychological distress (global severity index measure) following COBMINDEX. CONCLUSION: CD patients have a characteristic immunological profile that correlates with psychological stress, and disease severity. We suggest that COBMINDEX induces stress resilience in CD patients, which impacts their well-being, and their disease-associated inflammatory process.

Normative data for the Brief Symptom Inventory for patients with Crohn's disease.

OBJECTIVE: The Brief Symptom Inventory (BSI) is a self-report measure of psychological symptoms in clinical and non-clinical populations. However, norms for BSI are lacking for patients with chronic illness, such as Crohn's disease (CD). This study aimed to provide BSI clinical norms using a cohort of CD patients. DESIGN: Adult Israeli CD patients (n = 430) completed questionnaires regarding clinical, demographic and psychological aspects of disease, including BSI. Their BSI data were compared with published norms from adult Israeli population and British psychiatric outpatients. RESULTS: CD patients in active disease state had higher levels of mental health symptoms than those in remission. Interestingly, levels of symptomatology did not differ with respect to disease duration. No significant sex differences in BSI dimensions were found, with the exception of somatization. Being younger than 60 years and having lower economic status were associated with more severe psychological symptoms. Psychological symptom levels in CD patients were high in comparison to the Israeli general population, but low compared to British psychiatric outpatients. CONCLUSION: Results confirm the link between CD and elevated psychological symptoms. The findings highlight the need to use appropriate BSI norms when assessing clinically significant levels of psychological symptoms in non-psychiatric patients with chronic illness.

Randomized Controlled Trial of Cognitive-Behavioral and Mindfulness-Based Stress Reduction on the Quality of Life of Patients With Crohn Disease.

BACKGROUND: Patients with Crohn disease have debilitating psychological symptoms, mental fatigue, and poor quality of life. Psychological intervention may improve these symptoms. METHODS: We performed a randomized parallel-group physician-blinded trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) on quality of life and psychological symptoms in adults with mild-moderate Crohn disease. COBMINDEX was taught by social workers in one-on-one video conferences over 3 months; quotidian home practice was mandated. RESULTS: Fifty-five COBMINDEX and 61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women. At 3 months, COBMINDEX patients had significantly reduced disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score increased from baseline 41 to 50; P < 0.001), decreased psychological symptoms (Global Severity Index [GSI], 0.98-0.70; P < 0.001), reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, 26-33; P < 0.001), and increased mindfulness disposition (Freiburg Mindfulness Inventory, 33-38; P < 0.001). Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness. There were significant correlations (0.02 > P < 0.002) in COBMINDEX patients between baseline SIBDQ, GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores with a relative change (baseline to 3 months) of the SIBDQ score, but none among waitlist patients. Predictors of relative change of the SIBDQ score in COBMINDEX patients included the GSI score (90% quantile; coefficient 0.52; P < 0.001), somatization (90%; 0.20; P = 0.001), depression (75%; 0.16; P = 0.03), and phobic anxiety (75%; 0.31; P = 0.008). CONCLUSIONS: COBMINDEX was effective in increasing patients' quality of life and reducing psychological symptoms and fatigue. Patients with severe baseline psychological symptoms benefited the most from COBMINDEX.

Evaluation of a Short-Term Digital Group Intervention to Relieve Mental Distress and Promote Well-Being Among Community-Dwelling Older Individuals During the COVID-19 Outbreak: A Study Protocol.

Older individuals are at an increased risk of experiencing adverse social and health consequences due to both the COVID-19 pandemic and the measures taken to manage it, such as social distancing. To promote community-dwelling older individuals' well-being during this time, the aims of the current project are to develop effective strategies in order (a) to increase older individuals' digital literacy, and (b) to help them acquire behavioral and cognitive skills that will improve their coping abilities with the stressful situation created as a result of the pandemic, as well as reducing adverse mental health effects. The project comprises an intervention arm that includes digital group sessions for older individuals meant to improve their digital literacy, promote their effective coping, and relieve their mental distress and loneliness. Subjects receive a short-term (seven sessions), twice-weekly, digitally guided group intervention through Zoom (a video conferencing app), and WhatsApp (instant messaging app). The wait list control-group participants receive twice-weekly telephone calls from a research assistant during a parallel period. Web-based questionnaires are filled in pre- and post-participation. The effectiveness of the intervention will be analyzed by comparing pre- and post-measures, between intervention and control groups. This protocol offers a model for helping to support vulnerable populations during the COVID-19 pandemic. However, it is applicable regardless of the outbreak of a global health crisis or the imposition of lockdown rules; in fact, it has the potential to contribute to the social inclusion of vulnerable populations during routine times as well as during emergencies. Furthermore, ideas for future expansion include the integration of multilingual facilitators in order to reach seniors from underserved minority groups in various social contexts, even across borders.

Sense of Coherence Mediates the Links between Job Status Prior to Birth and Postpartum Depression: A Structured Equation Modeling Approach.

Postpartum depression (PPD) has detrimental effects on the health of the mother, child and family. Socio-demographic variables can influence PPD. Sense of coherence (SOC) is a personal resource that mitigates the experience of stressful events. We hypothesized that SOC would have a protective effect against PPD over time. The aim was to investigate the effects of socio-demographic factors and SOC on PPD at birth (T1) and nine months postpartum (T2). A longitudinal study of primiparous women (n = 114; age range 18-47 years) measured PPD, SOC and socio-demographics at T1 and T2. The majority were married, had no economic difficulties and were employed before birth. Results showed that PPD at T1 (15.8%) declined to 6.2% (T2). Job status was positively associated with SOC at T1. The structured equation model accounted for 27% of the variance in PPD (T2). In the first pathway, job status was linked to PPD (T2) via SOC at T1 and T2. In the second, SOC and PPD (T1) and SOC (T2) mediated the link between job status and PPD (T2). Results and clinical implications are discussed in the context of the theory of conservation of resources. An intervention for enhancing SOC is recommended for woman at risk of PPD.