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1.
Am J Gastroenterol ; 2024 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-39382574

RESUMO

Inflammatory Bowel Diseases (IBD) are chronic, often debilitating diseases characterized by inflammation of the digestive tract. IBDs affect up to 1% of the world's population and tend to be diagnosed in the second and third decades of life. In addition to physical burdens, IBDs have significant psychological manifestations stemming from bidirectional inflammatory and coping pathways and thus, are best understood from a biopsychosocial perspective. Though previous IBD literature has predominantly focused on traditional psychological comorbidities, such as anxiety and depression, recent studies have uncovered adjustment disorders, post-traumatic stress, and disordered eating as prevalent manifestations of the disease. This review will summarize the rates and postulated biopsychosocial mechanisms underlying these conditions to frame how cultivating resilience can protect against IBD symptoms and help forge a path towards emotional healing. We will also provide guidance to aid clinicians in screening for these conditions and creating a trauma-informed healthcare environment.

2.
Inflamm Bowel Dis ; 2024 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-39270637

RESUMO

BACKGROUND: Psychiatric disorders in patients with inflammatory bowel disease (IBD) represent a significant but uncertain facet of the disease, with unsolved questions regarding their overall magnitude, their impact on intestinal disease, and the whole burden of psychiatric manifestations. AIM: This systematic review summarizes the evidence on the prevalence and impact of psychiatric disorders, including depression, anxiety, bipolar disorder (BD), and schizophrenia, among patients with IBD. METHODS: A systematic search across PubMed/MEDLINE, Embase, and Scopus databases from January 2010 to January 2023 was performed to identify relevant studies. The focus was on studies exploring the prevalence of specific psychiatric disorders in IBD patients compared to the general population and that reported specific outcome measures. A subsequent meta-analysis (MA) assessed the strength of the association between IBD and these psychiatric disorders, with data reliability ensured through rigorous extraction and quality assessment. RESULTS: Out of 3,209 articles, 193 met the inclusion criteria and only 26 provided complete data for comprehensive analysis. These studies showed a significantly higher overall prevalence of psychiatric comorbidities in IBD patients compared to the general population. The MA showed a significant association between IBD and depression (pooled OR 1.42, 95% CI = 1.33-1.52, P < .0001) and anxiety (pooled OR 1.3, 95% CI = 1.22-1.44, P < .0001). The association between IBD and BD was significant (pooled OR 1.64, 95% CI = 1.20-2.24, P < .0001) but showed considerable heterogeneity (I2 = 94.01%). Only 3 studies examined the association between schizophrenia and IBD, providing widely heterogeneous results, with an inconclusive OR, estimated at 0.93 (95% CI = 0.62-1.39, P = .73). CONCLUSIONS: This MA highlights the high prevalence of psychiatric disorders, particularly depression and anxiety, in IBD patients, which exceeds rates in the general population. BD in IBD is proving to be an important but under-researched area. The sparse and contradictory data on schizophrenia requires further investigation. These findings highlight the need for better understanding, early detection, and tailored mental health interventions in the management of IBD to significantly improve patients' quality of life.


This systematic review with meta-analysis establishes a substantial association between inflammatory bowel diseases (IBD) and psychiatric disorders, primarily depression and anxiety. The study emphasizes the need for comprehensive mental health care in IBD management for improved patient outcomes.

3.
Inflamm Bowel Dis ; 2024 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-39173019

RESUMO

BACKGROUND: Studies have found a higher risk of comorbid anxiety and depression among patients with inflammatory bowel disease (IBD) compared with healthy individuals. If left untreated, comorbid depression and anxiety in patients with IBD can lead to poorer health outcomes and an increased healthcare utilization. The goal of this work was to develop a consensus statement to begin to address patient and provider needs and responsibilities related to screening and treatment of depression and anxiety symptoms among patients with IBD. METHODS: A literature scan was conducted to gather evidence-based background information and recommendations on the screening, diagnosis, and treatment of anxiety and depression in patients with IBD. This was followed by the engagement of a panel of IBD and mental health experts and patient advocates using a modified Delphi process to synthesize the literature and distill the information into a core set of statements to support provider actions and care delivery. RESULTS: Six statements were distilled from the literature and consensus process that link to the general management, screening, and treatment of anxiety and depression in patients with IBD. CONCLUSIONS: Mental healthcare and support for IBD patients is critical; the statements included in this article represent practical considerations for IBD healthcare professionals in addressing key issues on provider awareness, knowledge and behaviors, screening and treatment resources, and patient education.


This work aimed to develop a consensus statement on screening and treatment of anxiety and depression in individuals with inflammatory bowel disease. A literature scan was conducted, and an expert panel developed practical statements to guide inflammatory bowel disease healthcare professionals.

4.
Neurogastroenterol Motil ; : e14894, 2024 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-39135459

RESUMO

BACKGROUND: GI-specific psychological factors are important contributors to patients' symptom experience and quality of life across all disorders of gut-brain interaction (DGBI). Clinicians' ability to recognize the role of these psychological factors is essential for formulating a biopsychosocial case conceptualization and informing treatment decisions. PURPOSE: This article will familiarize gastroenterology providers with conceptualizing the role of GI-specific psychological factors in DGBI and provides stepwise, practical guidance for how to assess these during clinical encounters in a time-efficient manner.

5.
Artigo em Inglês | MEDLINE | ID: mdl-39025251

RESUMO

There is increasing recognition of the associated bi-directional impact of inflammatory bowel disease (IBD) on patient well-being and the potential benefit of multidisciplinary teams to address these unique needs. At certain IBD centers, there has been an evolution towards patient-centric, holistic care to enhance well-being and improve health-related outcomes. Multiple models, incorporating various disciplines, care modalities, digital tools and care delivery, and resource support have arisen in IBD. Although most IBD centers of excellence are now incorporating such multidisciplinary care models, many practices still practice IBD-limited specialty care, limiting evaluations and interventions to the IBD itself and its direct consequences (eg, extraintestinal manifestations). In this piece, we seek to review the evolution of IBD care towards a patient-centric, holistic model (termed 360 IBD Care) including the role and impact of digital health tools, monitoring, and delivery in IBD, and a shift towards value-based care models with discussion of payor priorities in IBD. We also suggest potential opportunities for IBD practitioners to incorporate elements of holistic care on a local scale. Together, we hope such care models will enhance not only IBD-specific health outcomes, but also improve the general well-being of our patients with IBD today and tomorrow.

7.
BMC Gastroenterol ; 24(1): 190, 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38822266

RESUMO

BACKGROUND: The inflammatory bowel disease self-efficacy scale (IBD-SES) is an instrument used across many countries to measure important health outcomes of patients with inflammatory bowel disease (IBD). We aimed to develop and validate a substantially shorter version of this scale to reduce patients' response burden. METHODS: A total of 919 patients with IBD, 482 recruited from an IBD clinic and 437 recruited online, completed the Japanese version of the original, 29-item IBD-SES. These data were then used to develop a shorter version of the scale. The original 29 items of the IBD-SES were reduced with three analytic steps: assessing ceiling and floor effect, testing correlation between items, and assessing test-retest reliability. The resulting 13-item IBD-SES was evaluated for construct validity by confirmatory factor analysis, criterion validity by Pearson correlation coefficients with original version, and internal consistency by item-total correlations and the Cronbach's α coefficient. RESULTS: The short version consisted of the same four subscales "managing stress and emotions," "managing medical care," "managing symptoms and disease," and "maintaining remission" as the original scale. The fit indices of the final model were as follows: normed chi-square, 7.18 (p < 0.001); comparative fit index, 0.94; goodness-of-fit index, 0.93; adjusted goodness-of-fit index, 0.89; parsimony goodness-of-fit index, 0.60; and root mean square error of approximation, 0.084. Correlation of each subscale with the original scale was high (0.97-0.98). Cronbach's α for each subscale ranged from 0.68 to 0.86. CONCLUSIONS: A short version of the IBD-SES was developed. The results confirmed the improved validity, reliability, and psychometric properties of the IBD-SES. TRIAL REGISTRATION: Not applicable.


Assuntos
Doenças Inflamatórias Intestinais , Psicometria , Autoeficácia , Humanos , Feminino , Masculino , Doenças Inflamatórias Intestinais/psicologia , Reprodutibilidade dos Testes , Adulto , Pessoa de Meia-Idade , Inquéritos e Questionários/normas , Análise Fatorial , Japão , Idoso , Adulto Jovem
8.
Nat Rev Gastroenterol Hepatol ; 21(6): 377-405, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38763974

RESUMO

The ability to experience pleasurable sexual activity is important for human health. Receptive anal intercourse (RAI) is a common, though frequently stigmatized, pleasurable sexual activity. Little is known about how diseases of the colon, rectum, and anus and their treatments affect RAI. Engaging in RAI with gastrointestinal disease can be difficult due to the unpredictability of symptoms and treatment-related toxic effects. Patients might experience sphincter hypertonicity, gastrointestinal symptom-specific anxiety, altered pelvic blood flow from structural disorders, decreased sensation from cancer-directed therapies or body image issues from stoma creation. These can result in problematic RAI - encompassing anodyspareunia (painful RAI), arousal dysfunction, orgasm dysfunction and decreased sexual desire. Therapeutic strategies for problematic RAI in patients living with gastrointestinal diseases and/or treatment-related dysfunction include pelvic floor muscle strengthening and stretching, psychological interventions, and restorative devices. Providing health-care professionals with a framework to discuss pleasurable RAI and diagnose problematic RAI can help improve patient outcomes. Normalizing RAI, affirming pleasure from RAI and acknowledging that the gastrointestinal system is involved in sexual pleasure, sexual function and sexual health will help transform the scientific paradigm of sexual health to one that is more just and equitable.


Assuntos
Doenças Retais , Humanos , Doenças Retais/fisiopatologia , Doenças Retais/terapia , Doenças Retais/etiologia , Doenças Retais/diagnóstico , Doenças do Colo/terapia , Doenças do Colo/fisiopatologia , Doenças do Colo/etiologia , Comportamento Sexual/fisiologia , Doenças do Ânus/terapia , Doenças do Ânus/fisiopatologia , Doenças do Ânus/etiologia , Doenças do Ânus/diagnóstico , Prazer/fisiologia , Disfunções Sexuais Fisiológicas/etiologia , Disfunções Sexuais Fisiológicas/terapia , Disfunções Sexuais Fisiológicas/fisiopatologia
9.
J Pediatr ; 273: 114123, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38815748

RESUMO

OBJECTIVE: To explore the mental health experiences of adolescents and young adults (AYA) with inflammatory bowel disease (IBD) enrolled in a randomized controlled trial evaluating the impact of a multimodal transition intervention. STUDY DESIGN: Virtual semistructured interviews were held with 21 AYA aged 16 through 18 years with IBD. Guided by qualitative description, interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive approach to reflexive thematic analysis. RESULTS: Three themes were generated from the data: (1) a continuum of integration between IBD and personal identity in adolescence and young adulthood; (2) manifestations of the mind-gut connection among AYA with IBD; and (3) hopes and priorities for addressing mental health in IBD care. CONCLUSIONS: AYA with IBD endorsed the criticality of incorporating mental health discussions into routine care during the transition to adult care, given the co-occurrence of psychosocial stressors throughout this period. A series of factors promoting and hindering the integration of IBD into one's identity were identified and could be explored in clinical encounters.


Assuntos
Doenças Inflamatórias Intestinais , Saúde Mental , Pesquisa Qualitativa , Transição para Assistência do Adulto , Humanos , Adolescente , Feminino , Masculino , Doenças Inflamatórias Intestinais/psicologia , Doenças Inflamatórias Intestinais/terapia , Adulto Jovem
10.
JMIR Ment Health ; 11: e55552, 2024 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-38663011

RESUMO

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.


Assuntos
Biorretroalimentação Psicológica , Frequência Cardíaca , Dispositivos Eletrônicos Vestíveis , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Biorretroalimentação Psicológica/métodos , Biorretroalimentação Psicológica/instrumentação , Pessoal de Saúde , Frequência Cardíaca/fisiologia , Cidade de Nova Iorque , Estudos Prospectivos , Telemedicina/métodos , Telemedicina/instrumentação
11.
Gastroenterology ; 166(6): 1182-1189, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38639677

RESUMO

DESCRIPTION: Pain is a common symptom among patients with inflammatory bowel disease (IBD). Although pain typically occurs during episodes of inflammation, it is also commonly experienced when intestinal inflammation is quiescent. Many gastroenterologists are at a loss how to approach pain symptoms when they occur in the absence of gut inflammation. We provide guidance in this area as to the evaluation, diagnosis, and treatment of pain among patients with IBD. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors. Formal ratings regarding the quality of evidence or strength of the presented considerations were not included because systematic reviews were not performed.


Assuntos
Gastroenterologia , Doenças Inflamatórias Intestinais , Manejo da Dor , Humanos , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/terapia , Doenças Inflamatórias Intestinais/diagnóstico , Gastroenterologia/normas , Manejo da Dor/métodos , Manejo da Dor/normas , Medição da Dor , Sociedades Médicas/normas
12.
Inflamm Bowel Dis ; 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38427713

RESUMO

The use of digital behavioral interventions was tested among patients with inflammatory bowel disease with a predominately low-income, Black/Hispanic background who had elevated symptoms of anxiety/depression. Both mood-tracking and cognitive behavioral self-management applications were feasible and acceptable to use, with opportunities for improvement identified.

13.
Artigo em Inglês | MEDLINE | ID: mdl-37932518

RESUMO

The COVID-19 pandemic resulted in increased feelings of emotional distress and disruptions in care across diverse patients subgroups, including those with chronic medical conditions such as inflammatory bowel diseases (IBD). We sought to understand the impact of the pandemic on the physical and emotional well-being of individuals with IBD and concurrent depression and/or anxiety symptoms. We conducted qualitative interviews after the beginning of the pandemic with 46 adults with IBD. Participants reported increased levels of emotional distress, feelings of social isolation, and uncertainty over whether IBD medications put them at increased risk. Young adults discussed feeling as if their lives had been disrupted. In addition, several individuals demonstrated resiliency and emphasized positives about the pandemic, including increased connectivity with family and friends, the convenience of being able to work from home despite their IBD symptoms, and lessened feelings of "missing out." Our findings highlight several opportunities to improve the health and well-being of individuals with IBD and beyond including increased support for combatting social isolation, enhanced counseling about medication risks and benefits, and the incorporation of resiliency skills building.

14.
Contemp Clin Trials ; 134: 107336, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37722485

RESUMO

BACKGROUND: Avoidant/restrictive food intake disorder (ARFID) symptoms are common (up to 40%) among adults with functional dyspepsia (FD), a disorder of gut-brain interaction characterized by early satiation, post-prandial fullness, epigastric pain, and/or epigastric burning. Using an 8-session exposure-based cognitive-behavioral treatment (CBT) for adults with FD + ARFID compared to usual care (UC) alone, we aim to: (1) determine feasibility, (2) evaluate change in clinical outcomes in, and (3) explore possible mechanisms of action. METHODS: We will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 1:1 ratio to CBT (with continued UC) or to UC alone. A priori primary benchmarks will be: ≥75% eligible participants enroll; ≥75% participants complete assessments; ≥70% participants attend 6/8 sessions; ≥70% of sessions have all content delivered; ≥70% participants rate Client Satisfaction Questionnaire scores above scale midpoint. We will also examine the size of changes in FD symptom severity and related quality of life within and between groups, and explore possible mechanisms of action. CONCLUSIONS: Findings from this trial will inform next steps with treatment development or evaluation-either for further refinement or for next-step efficacy testing with a fully-powered clinical trial.


Assuntos
Transtorno Alimentar Restritivo Evitativo , Dispepsia , Transtornos da Alimentação e da Ingestão de Alimentos , Adulto , Humanos , Dispepsia/terapia , Estudos de Viabilidade , Qualidade de Vida , Ingestão de Alimentos , Cognição , Estudos Retrospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Gastroenterol Clin North Am ; 52(3): 599-608, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37543403

RESUMO

Transition from pediatric to adult health care is a complex process that calls for complex interventions and collaboration between health care teams and families. However, many inflammatory bowel disease (IBD) clinical care teams do not have the resources to implement rigorous transition programs for youth. This review provides a description of the Resilience5: self-efficacy, disease acceptance, self-regulation, optimism, and social support. The Resilience5 represents teachable skills to support IBD self-management, offset disease interfering behaviors, and build resilience in adolescents and young adults transitioning to adult health care systems. These skills can also be encouraged and reinforced during routine IBD clinical care.


Assuntos
Doenças Inflamatórias Intestinais , Autogestão , Adolescente , Adulto Jovem , Humanos , Criança , Doenças Inflamatórias Intestinais/terapia , Equipe de Assistência ao Paciente
16.
Transpl Infect Dis ; 25(4): e14099, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37436814

RESUMO

Norovirus is the second most common cause of diarrhea among solid organ transplant recipients. There are currently no approved therapies for Norovirus, which can substantially impact quality of life, particularly in an immunocompromised patient population. In order to establish clinical efficacy and support any medication claims related to a patient's symptoms or function, the Food and Drug Administration requires that a trial's primary endpoints be derived from patient reported outcome measures- an outcome that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. In this paper, we describe our study team's approach to the definition, selection, measurement and evaluation of patient reported outcome measures as part of establishing clinical efficacy of Nitazoxanide for acute and chronic Norovirus in solid organ transplant recipients. We specifically describe our approach to measuring the primary efficacy endpoint- days to cessation of vomiting and diarrhea after randomization through 160 days, measured through daily symptom diaries as well as the impact of treatment on exploratory efficacy endpoints, particularly change in the impact of norovirus on psychological function and quality of life.

17.
Neurogastroenterol Motil ; 35(10): e14649, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37482914

RESUMO

BACKGROUND: Despite their high prevalence and burden, disorders of gut-brain interaction (DGBI) are undertaught and underrepresented in medical curricula. We evaluated the exposure of UK gastroenterology trainees to DGBI and their comfort managing these conditions. METHODS: An electronic survey was distributed to trainees via UK training program directors. The survey included questions on stage of training; subspecialty interest; access to DGBI training opportunities, and comfort levels with DGBI diagnosis and management. Responses were compared between junior and senior trainees, by subspecialty interest (luminal and non-luminal), by geographical region, and training program size. KEY RESULTS: One hundred twelve trainees from across the UK participated (21.4% of national training post holders). Exposure to DGBI lectures (32.8% junior vs. 73.3% senior trainees, p = 0.00003) and clinics (9.0% junior vs. 42.2% senior trainees, p = 0.00003), increased with seniority. Regardless of seniority, most trainees were rarely comfortable making a DGBI diagnosis (39.5% senior vs. 33.9% junior trainees, p = 0.69), and were not comfortable initiating neuromodulators (50% senior vs. 25.8% junior trainees, p = 0.08). Trainees without a luminal subspecialty interest (50%) accessed fewer DGBI clinics (p = 0.04), had less communication skills training (p = 0.04) and were less likely to have been observed during DGBI consultations (p = 0.002). Responses were similar across UK regions and did not differ between smaller and larger programs. CONCLUSIONS & INFERENCES: DGBI training opportunities are limited in UK gastroenterology training across training grades. Most trainees lack confidence with DGBI diagnosis and management. Urgent interventions need to be targeted at all stages of training to ensure DGBI competencies for future gastroenterologists and improve patient outcomes.


Assuntos
Gastroenterologia , Humanos , Gastroenterologia/educação , Educação de Pós-Graduação em Medicina/métodos , Inquéritos e Questionários , Reino Unido , Encéfalo
19.
Nat Rev Gastroenterol Hepatol ; 20(9): 582-596, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37268741

RESUMO

Irritable bowel syndrome (IBS) affects 5-10% of the global population. Up to one-third of people with IBS also experience anxiety or depression. Gastrointestinal and psychological symptoms both drive health-care use in people with IBS, but psychological comorbidity seems to be more important for long-term quality of life. An integrated care approach that addresses gastrointestinal symptoms with nutrition and brain-gut behaviour therapies is considered the gold standard. However, best practice for the treatment of individuals with IBS who have a comorbid psychological condition is unclear. Given the rising prevalence of mental health disorders, discussion of the challenges of implementing therapy for people with IBS and anxiety and depression is critical. In this Review, we draw upon our expertise in gastroenterology, nutrition science and psychology to highlight common challenges that arise when managing patients with IBS and co-occurring anxiety and depression, and provide recommendations for tailoring clinical assessment and treatment. We provide best practice recommendations, including dietary and behavioural interventions that could be applied by non-specialists and clinicians working outside an integrated care model.


Assuntos
Síndrome do Intestino Irritável , Humanos , Síndrome do Intestino Irritável/complicações , Síndrome do Intestino Irritável/epidemiologia , Síndrome do Intestino Irritável/terapia , Saúde Mental , Qualidade de Vida , Comorbidade , Ansiedade/epidemiologia , Ansiedade/terapia
20.
JMIR Res Protoc ; 12: e46307, 2023 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-37285195

RESUMO

BACKGROUND: Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse. OBJECTIVE: The primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention. METHODS: We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation. RESULTS: This project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington's institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025. CONCLUSIONS: This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46307.

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