SERENITY Study of Chronic Pain Interference in Adults (SERENITY)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Chronic Low Back Pain; Neuropathic Pain; Spinal Cord Injury; Pain Interference

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Ann Van de Winckel, PhD, MSPT; Phone Number: 612-406-2500; Email: avandewi@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
      • Contact: Ann Van de Winckel, PhD, MSPT; Phone Number: 612-406-2500; Email: avandewi@umn.edu
      • Principal Investigator: Ann Van de Winckel, PhD, MSPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference With Function	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Enjoyment of Life and General Activity Scale Score	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Ann Van de Winckel, PhD, MSPT, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Chronic pain; Chronic low back pain; Fitbit; EMA; SERENITY
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: PT-2026-35194; STUDY00029295 (Other Identifier: University Of Minnesota)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No