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SERENITY Study of Chronic Pain Interference in Adults (SERENITY)

9 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

400

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Ann Van de Winckel, PhD, MSPT
  • Numéro de téléphone: 612-406-2500
  • E-mail: avandewi@umn.edu

Lieux d'étude

  • États-Unis
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55455
        • University of Minnesota
        • Contact:
          • Ann Van de Winckel, PhD, MSPT
          • Numéro de téléphone: 612-406-2500
          • E-mail: avandewi@umn.edu
        • Chercheur principal:
          • Ann Van de Winckel, PhD, MSPT

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain Interference With Function
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain, Enjoyment of Life and General Activity Scale Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Minnesota

Collaborateurs

National Center for Complementary and Integrative Health (NCCIH)

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

30 septembre 2031

Achèvement de l'étude (Estimé)

30 septembre 2031

Dates d'inscription aux études

Première soumission

2 septembre 2026

Première soumission répondant aux critères de contrôle qualité

9 septembre 2026

Première publication (Réel)

15 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PT-2026-35194
  • STUDY00029295 (Autre identifiant: University Of Minnesota)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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