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NCT Number: NCT07820475

SERENITY Study of Chronic Pain Interference in Adults

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.

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Key information

Conditions

Chronic Low Back Pain Central Nervous System Diseases Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain Interference Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location contact

Ann Van de Winckel, PhD, MSPT

CONTACT

[email protected]

612-406-2500

Ann Van de Winckel, PhD, MSPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pain Interference With Function

    Time frame: 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

Secondary outcomes

  1. Pain, Enjoyment of Life and General Activity Scale Score

    Time frame: 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

  2. Brief Pain Inventory Short Form Pain Severity Composite Score

    Time frame: 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

  3. Brief Pain Inventory Short Form Pain Interference Composite Score

    Time frame: 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

  4. Spinal Cord Injury Functional Index/Assistive Technology Score

    Time frame: 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

  5. Roland-Morris Low Back Pain and Disability Questionnaire Score

    Time frame: 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

  6. Patient Health Questionnaire-4 Score

    Time frame: 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

  7. World Health Organization Quality of Life 2-Item Score

    Time frame: 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

  8. Cognitive and Affective Mindfulness Scale-Revised Score

    Time frame: 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

  9. Pain Resilience Scale Score

    Time frame: 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

  10. Positive and Negative Affect Schedule Short Form - Positive Affectivity Score

    Time frame: 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

  11. Positive and Negative Affect Schedule Short Form - Negative Affectivity Score

    Time frame: 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

  12. EMA Relaxation Score

    Time frame: 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

  13. EMA Energy Score

    Time frame: 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

  14. EMA Control Score

    Time frame: 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

  15. EMA Sleep Difficulty Score

    Time frame: 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

  16. EMA Fear of Movement Score

    Time frame: 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

  17. EMA Pain Intensity Score

    Time frame: 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

  18. Time to Completion for EMA Number Sequencing Task

    Time frame: 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

  19. Time to Completion for EMA Number-Letter Sequencing Task

    Time frame: 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

  20. Percent Correct for EMA Spatial Working Memory Task

    Time frame: 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

  21. Fitbit-Derived Sleep Duration

    Time frame: 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

  22. Fitbit-Derived Physical Activity

    Time frame: 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

  23. Fitbit-Derived Heart Rate

    Time frame: 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

  24. Fitbit-Derived Heart Rate Variability

    Time frame: 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

  25. Fitbit-Derived Daily Readiness Score

    Time frame: 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

  26. Fitbit-Derived Stress Management Score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Van de Winckel, PhD, MSPT

CONTACT

[email protected]

612-406-2500

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: SERENITY

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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