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Online Pain Education for Crohn's Disease and Ulcerative Colitis

25 de agosto de 2026 atualizado por: Christopher Almario, Cedars-Sinai Medical Center

Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease

Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai Medical Center
        • Investigador principal:
          • Christopher V Almario, MD, MSHPM
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Physician-confirmed diagnosis of Crohn's disease or ulcerative colitis
  • Chronic pain (visceral and/or somatic) related to IBD for at least 3 months
  • NIH PROMIS Pain Interference scale T-score ≥60

  • Medically stable, defined as:

    1. No acute IBD-related hospitalization within the past 3 months; AND
    2. No planned IBD surgery or planned therapeutic escalation within the next 2 months, including initiation of a new advanced therapy, dose escalation or switch of advanced therapy, or corticosteroid taper
  • Able to understand and complete questionnaires independently in English
  • Access to an internet-enabled device for online surveys and intervention access.

Exclusion Criteria:

  • Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation
  • Current use of standing opioid medications, given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
  • Prior participation in cognitive behavioral therapy (CBT) specifically targeting chronic IBD-related pain

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Empowered Relief
Participants randomized to the Empowered Relief arm will be scheduled to attend a 2-hour, live-online group Empowered Relief session. Empowered Relief sessions will be conducted via Zoom. Attendance of the Empowered Relief session will be monitored by study staff throughout the 2-hour session. Following the Empowered Relief session, participants in this arm will be provided with access to the 20-minute binaural audio relaxation app the that accompanies the Empowered Relief program and promotes calm through brainwave entrainment. Participants will be instructed to utilize the binaural audio app daily for the 8-weeks following the completion of the Empowered Relief session.
Comportamental: Empowered Relief
Empowered Relief is an online pain education program. Empowered Relief 'compresses' key cognitive behavioral therapy skills, mindfulness principles, and pain neuroscience education into a highly pragmatic, scalable, single 2-hour session. Taught via Zoom by certified instructors to large groups of patients, it teaches participants to identify unhelpful pain-related thoughts, manage physiological hyperarousal, and build coping skills through cognitive reframing, guided relaxation, and self-soothing techniques. Participants receive a 20-minute binaural audio relaxation app that promotes calm through brainwave entrainment.
Comparador de Placebo: Living Better with Chronic Pain
Participants randomized to the Living Better with Chronic Pain arm will be sent a link to access the 2-hour, online recording. Completion of the entire Living Better with Chronic Pain video will be monitored and confirmed by study staff.
Comportamental: Living Better with Chronic Pain
Living Better with Chronic Pain is a 2-hour online health program that provides education regarding chronic pain mechanisms, nutrition and weight management, physical activity, working with healthcare providers, informed treatment decisions, and medication safety.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
PROMIS Pain Interference
Prazo: Baseline, then weekly post-treatment (Weeks 1-8)
Pain interference as measured by the validated 8-item PROMIS Pain Interference (PROMIS-PI) scale. It assesses self-reported consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life. This instrument is universal, rather than disease-specific. The recall period for this scale is 7 days.
Baseline, then weekly post-treatment (Weeks 1-8)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
PROMIS Pain Intensity
Prazo: Baseline, then weekly post-treatment (Weeks 1-8)
Pain intensity as measured by the validated 1-item PROMIS Pain Intensity Numeric Rating Scale (NRS). It asks how one would rate their pain on average over the last 7 days, on a scale of 0 to 10.
Baseline, then weekly post-treatment (Weeks 1-8)
PROMIS Abdominal Pain
Prazo: Baseline, then weekly post-treatment (Weeks 1-8)
Abdominal pain as measured by the validated 5-item PROMIS Abdominal Pain scale. PROMIS Abdominal Pain assesses the severity of belly pain over the past 7 days. This instrument is universal, rather than disease-specific.
Baseline, then weekly post-treatment (Weeks 1-8)
Pain Catastrophizing Scale
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
Pain catastrophizing as measured by the validated 13-item Pain Catastrophizing Scale (PCS). It assesses the types of thoughts and feeling that one has when in pain. This scale does not have a specified recall period, but asks for one to review various statements describing different thoughts and feelings that may be associated with pain, and respond based on when experiencing pain previously.
Baseline, then at Weeks 4 and 8 post-treatment
Pain Self-Efficacy
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
Pain self-efficacy as measured by the validated 10-item Pain Self-Efficacy Questionnaire (PSEQ). This scale does not have a specified recall period, but asks for one to rate on a scale of 0 to 6 how confident they are that they can do various things at present, despite the pain.
Baseline, then at Weeks 4 and 8 post-treatment
Inflammatory Bowel Disease Disability Index
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
The Inflammatory Bowel Disease Disability Index is a validated, disease-specific measure that assesses the impact of Crohn's disease and ulcerative colitis on daily functioning, including physical health, body functions, activities, participation, and overall disability.
Baseline, then at Weeks 4 and 8 post-treatment
IBD Control Questionnaire
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
IBD symptoms as measured by the validated 8-item and 1-question visual analog scale (VAS) IBD Control questionnaire. It assesses perceived control over symptoms, usefulness of current treatment, and impact of IBD on various domains over the past 2 weeks.
Baseline, then at Weeks 4 and 8 post-treatment

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Pain Location Assessment
Prazo: Baseline, then weekly post-treatment (Weeks 1-8)
Pain location as measured by a 1-item Pain Location Assessment questionnaire which asks one to select from a list all of the locations on the body where they have experienced pain in the last 7 days.
Baseline, then weekly post-treatment (Weeks 1-8)
PROMIS Sleep Disturbance
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
Sleep disturbance as measured by the validated 4-item PROMIS Sleep Disturbance questionnaire. It assesses self-reported perceptions of sleep quality, sleep process, and restoration associated with sleep. The recall period for this scale is 7 days.
Baseline, then at Weeks 4 and 8 post-treatment
Treatment Appraisal and Satisfaction
Prazo: Day 1 post-treatment
Treatment appraisal and satisfaction as measured by a 20-item Treatment Appraisal and Satisfaction Survey. It assess usability, relevance, usefulness, and how likely one is to recommend the program to others.
Day 1 post-treatment
PROMIS Anxiety
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
Perceived anxiety as measured by the the validated 8-item PROMIS Emotional Distress - Anxiety scale. It assesses self-reported fear, anxious misery, and hyperarousal. The recall period for this scale is 7 days.
Baseline, then at Weeks 4 and 8 post-treatment
PROMIS Depression
Prazo: Baseline, then at Weeks 4 and 8 post-treatment
Perceived depression as measured by the the validated 8-item PROMIS Emotional Distress - Depression scale. It assesses self-reported negative mood, views of self, and social cognition. The recall period for this scale is 7 days.
Baseline, then at Weeks 4 and 8 post-treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cedars-Sinai Medical Center

Investigadores

  • Investigador principal: Christopher V Almario, MD, MSHPM, Cedars-Sinai Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

22 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de junho de 2026

Primeira postagem (Real)

26 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de agosto de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00005007

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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