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

Pain Reprocessing Therapy for Chronic Widespread Pain - A Randomized Multiple-baseline SCED Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Chronic Pain; Chronic Widespread Pain; Fibromyalgia
• Intervention / Treatment: Behavioral: Pain Reprocessing Therapy

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 1900
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological Momentary Assessment (EMA) questionnaire	Participants will answer EMA questions 4 times per day (morning, noon/early afternoon, afternoon, and evening) during the baseline period (6-14 days, pseudorandomized) and throughout the intervention period (4-8 weeks). Every questionnaire includes questions about current activity, affect, mood, pain, and social connectedness. The morning questionnaire includes an additional question about sleep quality, and the evening questionnaire includes additional questions about rest, feeling present, medicine use, pain-related worrying, overall pain intensity, perceived ability to manage pain, adjustment of daily activities due to pain, and avoidance of pain throughout the day. Additionaly, each individual answer a personal targeted question (evening only) formulated in collaboration with the patient with at baseline. While most questions are rated using Visual Analog Scale (VAS), some use open text (current activity, medicine), yes/no (current pain), multiple choice (pain location, rest).	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	The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Brief Pain Inventory (BPI) - Pain interference	The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.	From enrolment to the end of treatment at 4-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a 13 item scale that measures catastrophic thinking related to pain. The questionnaire is rated using a 0-4 Likert scale and is scored using the three subscales rumination, magnification, and helplessness, or a total sum score for all items.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Pain Coping Questionnaire - short form	The Pain Coping Questionnaire (short form) is a 16-item questionnaire that is rated using a 1-5 Likert scale.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the State-Trait Anxiety Inventory (State questionnaire only)	The State-Trait Anxiety Inventory (STAI) consists of two similar 20-item questionnaires that measures trait-based anxiety and state-based (situational) anxiety, rated on a 1-4 Likert scale. Only the part measuring state (situational) anxiety will be used.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Generalized Anxiety Disorder Assessment (GAD-7)	The GAD-7 is a 7-item scale that measures generalized anxiety, and is routinely used as a screening tool for generalized anxiety disorder. The questionnaire uses a 0-3 Likert scale.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Becks Depression Inventory II (BDI-2)	The BDI-2 is a 21-item questionnaire measuring depression, using a 0-3 Likert scale	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS)	The SHAPS measures the capacity to experience pleasure (hedonic tone) and uses a 1-4 Likert scale. A higher score indicates higher level of anhedonia.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Life Satisfaction Questionnaire (LISAT-11)	The LISAT-11 is an 11-item scale measuring satisfaction with different aspects of life and uses a 1-6 Numeric Rating Scale.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the PROMIS-29	The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item questionnaire designed for chronic pain patients, that measures physical function, anxiety, depression, fatigue, sleep problems, ability to participate in social activities, pain interference in activities, and pain intensity.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Multidimensional Assessment of Interoceptive Awareness 2 brief version (brief MAIA-2)	The brief MAIA-2 is a 24-item scale measures different aspects of interoceptive awareness using a 0-5 Numeric Rating Scale.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Perceived Stress Scale brief version	The Perceived Stress Scale (brief version) is a 10-item scale measuring thoughts and feelings about stress using a 0-4 Likert Scale.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Stress Mindset Measure (SMM)	The SMM is a 8-item scale measuring the extent to which an individual adopts a mindset that the effects of stress are enhancing or debilitating. It uses a 0-4 Likert Scale.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the brief Existential Isolation Scale	The EIS is a 6-item scale that measures social isolation as an existential experience, and uses a 0-9 Numeric Rating Scale.	From enrolment to the end of treatment at 4-6 weeks
Change in the Working Alliance Inventory (WAI) throughout the course of Pain Reprocessing Therapy	The WAI is a 12-item questionnaire measuring the therapeutic alliance between a psychotherapist and a client, and is answered by the client. The WAI uses a 1-7 Likert Scale.	Up to 6 hours after every 2 PRT sessions (assessed until the last PRT session, up to 4-6 weeks after enrolment)
Life Orientation Test (LOT-R)	The revised Life Orientation Test (LOT-R) is a 10-item questionnaire measuring dispositional optimism and pessimism, and uses a 0-4 Likert scale, in which higher scores indicate higher dispositional optimism and lower dispositional pessimism.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Brief Pain Inventory (BPI) - Medication	The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.	From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Brief Pain Inventory (BPI) - Body map	The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.	From enrolment to the end of treatment at 4-6 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Kristiania University College
• Investigators: Principal Investigator: Dan-Mikael Ellingsen, PhD, Oslo University Hospital: Oslo Universitetssykehus

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 12, 2025
• First Submitted That Met QC Criteria: June 25, 2025
• First Posted (Actual): July 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Fibromyalgia; Chronic widespread pain; Single-case experimental design; SCED; Pain reprocessing therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Fibromyalgia; Chronic Pain
• Other Study ID Numbers: 2025032 (Helse Sør-øst)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data from participants who agree to have their anonymized data shared for research purposes will be made available.
• IPD Sharing Time Frame: From publication of the primary results until 5 years after study completion.
• IPD Sharing Access Criteria: Anonymized data and analysis code will be shared through publicly available databases such as Open Science Framework.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No