Active — Not RecruitingNot Applicable

Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study

Norway15 participantsStarted 2025-05-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-65 (inclusive) * Qualifying for Chronic Widespread Pain (CWP), as described in ICD-11 (an existing diagnosis of fibromyalgia qualifies for CWP) * Baseline pain with an average intensity of at least 4/10 that has lasted for 3 months or longer * If on medication that could potentially interfere with study participation or outcomes as evaluated by the study physician, stable doses of medication for 6 weeks prior to entering the study and during participation * Living in Norway * Fluent in Norwegian * Normal or corrected-to-normal vision * Access to smartphone or equivalent for use of app during study Exclusion Criteria: * Current comorbid acute pain condition (pain from acute illness, injury, infection, or similar in the past 3 weeks) * Beck Depression Index (BDI) score more than 30 * Clinical high risk for suicidality (BDI short form item 7 on suicidality rated ≥ 2, or modaterate/high scores for suicidality in M.I.N.I. interview) * Current psychological therapy for pain or mental health purposes * Any current or past diagnosis and/or significant symptoms of psychosis-related disorders (schizophrenia, schizoaffective disorder), bipolar disorder, autism spectrum disorder, personality disorder * Current diagnosis and/or significant symptoms of post-traumatic stress disorder (PTSD), eating disorder, substance use disorder, obsessive-compulsive disorder (OCD) * Currently participating in other therapeutic trials * Currently in a legal process regardin…

What they're measuring

Ecological Momentary Assessment (EMA) questionnaire

Timeframe: During baseline (6-14 days, pseudorandomized) and throughout the intervention period (4-6 weeks)

Change from baseline in the Brief Pain Inventory (BPI) - Pain severity

Timeframe: From enrolment to the end of treatment at 4-6 weeks

Change from baseline in the Brief Pain Inventory (BPI) - Pain interference

Timeframe: From enrolment to the end of treatment at 4-6 weeks

Trial details

NCT IDNCT07050758

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Pain trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ecological Momentary Assessment (EMA) questionnaire

Timeframe: During baseline (6-14 days, pseudorandomized) and throughout the intervention period (4-6 weeks)

Change from baseline in the Brief Pain Inventory (BPI) - Pain severity

Timeframe: From enrolment to the end of treatment at 4-6 weeks

Change from baseline in the Brief Pain Inventory (BPI) - Pain interference

Timeframe: From enrolment to the end of treatment at 4-6 weeks