SERENITY Study of Chronic Pain Interference in Adults
Not yet recruitingNCT07820475
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Modeling of Inter-Individual Differences in Chronic Pain Using Holistic Measures of Pain Severity, Stress, Cognition, Body and Mind Awareness
- Conditions
- Chronic Low Back Pain
- Spinal Cord Injury
- Neuropathic Pain
- Chronic Pain
- Pain Interference
- Sponsor
- University of Minnesota
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2026-11-01
- Primary completion
- 2031-09-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07820475