Clinical Trial

Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study

Study acronym: FOKUS
Active, Not Recruiting
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Record status
This record was last updated September 10, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Chronic Widespread Pain (CWP) is classified as a Chronic Primary Pain syndrome in the ICD-11 and is considered a major type of nociplastic pain with an estimated prevalence of up to 8-10% in the general population. Many CWP patients experience inadequate treatment and poor symptom management, leaving them prone to disability. Pain Reprocessing Therapy (PRT) is a novel therapy specifically designed to target nociplastic pain with a combination of cognitive, exposure-based, and interoceptively-focused psychotherapy techniques. A recent clinical trial indicated large effects of PRT for chronic back pain, but no studies have yet investigated PRT for CWP. Furthermore, there is little knowledge about how pain and other outcomes change during PRT intervention (between baseline and post-intervention timepoints). The investigators will use a Single-Case Experimental Design (SCED) to investigate PRT for CWP. Primary outcomes include pain collected at the baseline visit and the post-intervention visit, and Ecological Momentary Assessment (EMA) outcomes including pain, mood, sleep, behavior, and medication, collected up to 4 times per day during the baseline and PRT (intervention) period. Secondary outcomes include a range of state-based outcomes collected at the baseline visit and the post-intervention visit.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-25.
Status change: Recruiting → Active, Not Recruiting 2025-09-03
Trial Details
NCT Number NCT07050758
Lead Sponsor Oslo University Hospital
Collaborators: Kristiania University College
Conditions Pain, Chronic Widespread Pain, Chronic Pain, Fibromyalgia
Enrollment 15 participants
Start Date 2025-05-07
Primary Completion 2025-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-10