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Online Pain Education for Crohn's Disease and Ulcerative Colitis

25 de agosto de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Zoe Krut, MSHS
  • Número de teléfono: 310-423-0699
  • Correo electrónico: Zoe.Krut@cshs.org

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai Medical Center
        • Investigador principal:
          • Christopher V Almario, MD, MSHPM
        • Contacto:
          • Zoe Krut, MSHS
          • Número de teléfono: 310-423-0699
          • Correo electrónico: Zoe.Krut@cshs.org

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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 placebos: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PROMIS Pain Interference
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PROMIS Pain Intensity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Location Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Cedars-Sinai Medical Center

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2026

Publicado por primera vez (Actual)

26 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de agosto de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00005007

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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