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SERENITY Study of Chronic Pain Interference in Adults (SERENITY)

9 de septiembre de 2026 actualizado por: University of Minnesota

Modeling of Inter-Individual Differences in Chronic Pain Using Holistic Measures of Pain Severity, Stress, Cognition, Body and Mind Awareness

SERENITY is a remote observational study designed to characterize inter-individual differences in chronic pain among adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain.

Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection. Ecological momentary assessment surveys will be completed 4 times per day for at least 3 weeks and will assess pain interference, pain intensity, stress, affect, sleep, body and mind awareness, agency, medication use, manual therapy frequency, and related factors.

The study will use Bayesian hierarchical modeling, clustering analyses, and causal discovery approaches to identify person-specific and group-level factors associated with pain interference.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

Chronic pain is heterogeneous, and individuals with similar pain diagnoses may experience different levels of pain interference and may have different factors contributing to pain-related disability. SERENITY is a remote observational study designed to characterize between-subject heterogeneity in adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain.

The study will enroll 200 adults with chronic low back pain and 200 adults with spinal cord injury-related neuropathic pain. Participants will complete baseline demographic, clinical, pain, emotional functioning, physical functioning, and quality-of-life assessments. Participants will also complete ecological momentary assessment surveys 4 times per day for at least 3 weeks. These surveys will assess pain intensity, pain interference with function, positive and negative affect, stress, sleep, body and mind awareness, agency or perceived control over pain and life, medication dosage, manual therapy frequency, and brief cognitive test performance.

Fitbit data will be collected passively during the study period to measure sleep, physical activity, heart rate, heart rate variability, daily readiness, and stress management. The study will use intensive longitudinal data from ecological momentary assessment surveys and Fitbit measures to develop Bayesian hierarchical models, pain-profile clusters, and personal causal models.

The primary objective is to identify SERENITY measures associated with or causally related to pain interference within each pain group. The study will also examine heterogeneity in pain profiles and explore person-specific causal relationships between pain interference and measures of pain severity, stress, cognition, body and mind awareness, affect, and agency.

Tipo de estudio

De observación

Inscripción (Estimado)

400

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

  • Nombre: Ann Van de Winckel, PhD, MSPT
  • Número de teléfono: 612-406-2500
  • Correo electrónico: avandewi@umn.edu

Ubicaciones de estudio

  • Estados Unidos
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota
        • Contacto:
          • Ann Van de Winckel, PhD, MSPT
          • Número de teléfono: 612-406-2500
          • Correo electrónico: avandewi@umn.edu
        • Investigador principal:
          • Ann Van de Winckel, PhD, MSPT

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

Método de muestreo

Muestra no probabilística

Población de estudio

Adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain will be recruited nationwide for this remote observational study. Participants will be 18 years or older, medically stable, fluent in English, and have pain severity of at least 4 out of 10 over the past week. Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection.

Descripción

Inclusion Criteria:

  • Age 18 years or older
  • Chronic low back pain for more than 3 months, or complete or incomplete spinal cord injury for more than 1 year with spinal cord injury-related neuropathic pain
  • Medically stable
  • Pain severity of at least 4 out of 10 on the numeric pain rating scale over the past week
  • Fluent in English
  • Access to the internet and a computer, iPad, or smartphone; study equipment may be provided if needed
  • Currently on stable pain medication or manual therapy appointments as part of clinical care

Exclusion Criteria:

  • Cognitive impairment or communicative disability preventing the participant from following directions
  • Major medical complications
  • Pregnancy
  • Current active treatments that could potentially influence SERENITY outcomes, such as cognitive behavioral therapy or Qigong
  • Children
  • Prisoners
  • Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
  • Non-English speakers
  • Individuals unable to read
  • Employees of the researcher
  • Students of the researcher
  • Active members of the military or DoD personnel

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

Cohortes e Intervenciones

Grupo / Cohorte
Adults With Chronic Low Back Pain
Adults with chronic low back pain for more than 3 months and pain severity of at least 4 out of 10 over the past week. Participants will complete baseline questionnaires, ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection.
Adults With SCI-Related Neuropathic Pain
Adults with complete or incomplete spinal cord injury of more than 1 year, medically stable, with spinal cord injury-related neuropathic pain and pain severity of at least 4 out of 10 over the past week. Participants will complete baseline questionnaires, ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Interference With Function
Periodo de tiempo: Four times daily for at least 3 weeks

Pain interference with function will be assessed using a single ecological momentary assessment item: "How much is your low back pain/neuropathic pain affecting your daily life function?" Response options range from 0 to 4, with higher scores indicating worse pain interference with function. This is not a standardized scale and is administered via ecological momentary assessment to support causal discovery pathways.

Unit: points
Four times daily for at least 3 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain, Enjoyment of Life and General Activity Scale Score
Periodo de tiempo: Baseline

Pain severity and impact will be assessed using the Pain, Enjoyment of Life and General Activity scale. This 3-item scale has a minimum score of 0 and maximum score of 30, with higher scores indicating worse pain severity and impact.

Unit: points
Baseline
Brief Pain Inventory Short Form Pain Severity Composite Score
Periodo de tiempo: Baseline

Pain severity will be assessed using the Brief Pain Inventory Short Form 7-day recall. The pain severity composite includes 4 items, with scores ranging from 0 to 10. Higher scores indicate worse pain severity.

Unit: points
Baseline
Brief Pain Inventory Short Form Pain Interference Composite Score
Periodo de tiempo: Baseline

Pain interference will be assessed using the Brief Pain Inventory Short Form 7-day recall. The pain interference composite includes 7 items, with scores ranging from 0 to 10. Higher scores indicate worse pain interference.

Unit: Points
Baseline
Spinal Cord Injury Functional Index/Assistive Technology Score
Periodo de tiempo: Baseline

Physical functioning among participants with spinal cord injury will be assessed using the Spinal Cord Injury Functional Index/Assistive Technology measure. This 32-item measure has a minimum score of 0 and maximum score of 128, with higher scores indicating better physical functioning.

Unit: Points
Baseline
Roland-Morris Low Back Pain and Disability Questionnaire Score
Periodo de tiempo: Baseline

Low back pain-related disability among participants with chronic low back pain will be assessed using the Roland-Morris Low Back Pain and Disability Questionnaire. This 24-item measure has a minimum score of 0 and maximum score of 24, with higher scores indicating worse disability.

Unit: Points
Baseline
Patient Health Questionnaire-4 Score
Periodo de tiempo: Baseline

Depression and anxiety symptoms will be assessed using the Patient Health Questionnaire-4. This 4-item measure has a minimum score of 0 and maximum score of 12, with higher scores indicating worse depression and anxiety symptoms.

Unit: Points
Baseline
World Health Organization Quality of Life 2-Item Score
Periodo de tiempo: Baseline

Quality of life and health satisfaction will be assessed using the World Health Organization Quality of Life 2-item measure. Each item is scored on a 5-point Likert scale. Total scores range from 2 to 10, with higher scores indicating better quality of life and health satisfaction.

Unit: Points
Baseline
Cognitive and Affective Mindfulness Scale-Revised Score
Periodo de tiempo: Baseline

Mindful qualities will be assessed using the Cognitive and Affective Mindfulness Scale-Revised. This 12-item measure is scored from 1 to 4 per item. Total scores range from 1 to 48, with higher scores indicating better mindfulness-related qualities.

Unit: Points
Baseline
Pain Resilience Scale Score
Periodo de tiempo: Baseline

Pain resilience will be assessed using the Pain Resilience Scale. This 14-item measure uses a 5-point Likert scale scored from 0 to 4 per item. Total scores range from 0 to 56, with higher scores indicating better positive adaptation to pain.

Unit: Points
Baseline
Positive and Negative Affect Schedule Short Form - Positive Affectivity Score
Periodo de tiempo: Four times daily for at least 3 weeks

Positive affectivity will be assessed using the Positive and Negative Affect Schedule Short Form. Items are scored from 1 to 5. Total scores range from 5 to 25, with higher scores indicating better positive affectivity.

Unit: Points
Four times daily for at least 3 weeks
Positive and Negative Affect Schedule Short Form - Negative Affectivity Score
Periodo de tiempo: Four times daily for at least 3 weeks

Negative affectivity will be assessed using the Positive and Negative Affect Schedule Short Form. Items are scored from 1 to 5. Total scores range from 5 to 25, with higher scores indicating worse negative affectivity.

Unit: Points
Four times daily for at least 3 weeks
EMA Relaxation Score
Periodo de tiempo: Four times daily for at least 3 weeks

Relaxation will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better relaxation.

Unit: points
Four times daily for at least 3 weeks
EMA Energy Score
Periodo de tiempo: Four times daily for at least 3 weeks

Energy will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better energy.

Unit: points
Four times daily for at least 3 weeks
EMA Control Score
Periodo de tiempo: Four times daily for at least 3 weeks

Perceived control will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better perceived control.

Unit: points
Four times daily for at least 3 weeks
EMA Sleep Difficulty Score
Periodo de tiempo: Four times daily for at least 3 weeks

Sleep difficulty will be assessed using single ecological momentary assessment items related to trouble falling asleep, trouble staying asleep, and waking up too early. Each item will be scored separately from 0 to 4, with higher scores indicating worse sleep difficulty.

Unit: points
Four times daily for at least 3 weeks
EMA Fear of Movement Score
Periodo de tiempo: Four times daily for at least 3 weeks

Fear of movement because of pain will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating worse fear of movement.

Unit: points
Four times daily for at least 3 weeks
EMA Pain Intensity Score
Periodo de tiempo: Four times daily for at least 3 weeks

Pain intensity will be assessed using a single ecological momentary assessment item measuring pain intensity at the time of assessment. Scores range from 0 to 10, with higher scores indicating worse pain intensity.

Unit: points
Four times daily for at least 3 weeks
Time to Completion for EMA Number Sequencing Task
Periodo de tiempo: Four times daily for at least 3 weeks

Attention will be assessed using a smartphone-based number sequencing task. Performance will be reported as time to completion.

Unit: Seconds
Four times daily for at least 3 weeks
Time to Completion for EMA Number-Letter Sequencing Task
Periodo de tiempo: Four times daily for at least 3 weeks

Set-shifting will be assessed using a smartphone-based number-letter sequencing task. Performance will be reported as time to completion.

Unit: Seconds
Four times daily for at least 3 weeks
Percent Correct for EMA Spatial Working Memory Task
Periodo de tiempo: Four times daily for at least 3 weeks

Spatial working memory will be assessed using a smartphone-based spatial working memory task. Performance will be reported as percent correct.

Unit: percent correct
Four times daily for at least 3 weeks
Fitbit-Derived Sleep Duration
Periodo de tiempo: Throughout the study assessment period, at least 3 weeks

Sleep duration will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: hours
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Physical Activity
Periodo de tiempo: Throughout the study assessment period, at least 3 weeks

Physical activity will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: Steps
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate
Periodo de tiempo: Throughout the study assessment period, at least 3 weeks

Heart rate will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: beats per minute
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate Variability
Periodo de tiempo: Throughout the study assessment period, at least 3 weeks

Heart rate variability will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: milliseconds
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Daily Readiness Score
Periodo de tiempo: Throughout the study assessment period, at least 3 weeks

Daily readiness will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: points
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Stress Management Score
Periodo de tiempo: Throughout the study assessment period, at least 3 weeks

Stress management will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: points
Throughout the study assessment period, at least 3 weeks

Colaboradores e Investigadores

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

Patrocinador

University of Minnesota

Colaboradores

National Center for Complementary and Integrative Health (NCCIH)

Investigadores

  • Investigador principal: Ann Van de Winckel, PhD, MSPT, University of Minnesota

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 octubre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2031

Finalización del estudio (Estimado)

30 de septiembre de 2031

Fechas de registro del estudio

Enviado por primera vez

2 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Publicado por primera vez (Actual)

15 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

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

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PT-2026-35194
  • STUDY00029295 (Otro identificador: University Of Minnesota)

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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