Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study (FOKUS)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Fibromyalgia; Chronic Pain; Chronic Widespread Pain; Pain

Treatments: Behavioral: Pain Reprocessing Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07050758

2025032

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Pain Reprocessing Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Reprocessing Therapy