Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study

NCT ID: NCT07050758

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2026-09-30

Brief 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.

Conditions

Pain; Chronic Widespread Pain; Chronic Pain; Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pain Reprocessing Therapy

After a baseline period of 6-14 days (pseudorandomized duration), patients will undergo 9 interventional sessions over a span of 4-6 weeks. This includes an initial consultation with a medical doctor in order to confirm that clinical inclusion criteria are met and exclude potential structural (nociceptive or neuropathic) causes of pain. After this consultation, participants undergo 8 PRT sessions with a clinical psychologist trained in PRT.

Group Type: EXPERIMENTAL

Pain Reprocessing Therapy

Intervention Type: BEHAVIORAL

Each PRT session will take 45-60 minutes and includes psychoeducation about the association between pain and the brain, mindfulness, and exposure- and acceptance-based concepts. Through PRT, participants will learn about how pain can emerge from 'stuck patterns' in neural circuits in the brain. Through reflections of their own pain experiences, the patient explores evidence for whether this applies to their own pain. Patients will acquire corrective experiences in which their brain "learns" not to respond with pain ("false alarm") in situations that are safe. One central reprocessing exercise is 'somatic tracking', in which participants explore their pain sensations in a context of safety. This includes interoceptive exposures and situational exposures to activities they fear will trigger pain. Exploring these sensations and situations through a lens of safety and curiosity allows the participants to reinterpret bodily sensations previously associated with threat or pain, as safe.

Interventions

Pain Reprocessing Therapy

Each PRT session will take 45-60 minutes and includes psychoeducation about the association between pain and the brain, mindfulness, and exposure- and acceptance-based concepts. Through PRT, participants will learn about how pain can emerge from 'stuck patterns' in neural circuits in the brain. Through reflections of their own pain experiences, the patient explores evidence for whether this applies to their own pain. Patients will acquire corrective experiences in which their brain "learns" not to respond with pain ("false alarm") in situations that are safe. One central reprocessing exercise is 'somatic tracking', in which participants explore their pain sensations in a context of safety. This includes interoceptive exposures and situational exposures to activities they fear will trigger pain. Exploring these sensations and situations through a lens of safety and curiosity allows the participants to reinterpret bodily sensations previously associated with threat or pain, as safe.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 regarding disability benefits.
• Currently pregnant
• Started an antidepressant or changed dose in the past 6 weeks
• Inability to reliably complete tasks related to the study
• Any impairment, activity or situation that in the judgement of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kristiania University College

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dan-Mikael Ellingsen

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dan-Mikael Ellingsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital: Oslo Universitetssykehus

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2025032

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025032

Identifier Type: -

Identifier Source: org_study_id