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NCT Number: NCT07050758

Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pain Chronic Pain Chronic Widespread Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 1900, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Reprocessing Therapy

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.

Primary outcomes

  1. Ecological Momentary Assessment (EMA) questionnaire

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

    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).

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

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

    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.

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

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

    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.

Secondary outcomes

  1. Change from baseline in the Pain Catastrophizing Scale (PCS)

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

    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.

  2. Change from baseline in the Pain Coping Questionnaire - short form

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

    The Pain Coping Questionnaire (short form) is a 16-item questionnaire that is rated using a 1-5 Likert scale.

  3. Change from baseline in the State-Trait Anxiety Inventory (State questionnaire only)

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

    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.

  4. Change from baseline in the Generalized Anxiety Disorder Assessment (GAD-7)

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

    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.

  5. Change from baseline in the Becks Depression Inventory II (BDI-2)

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

    The BDI-2 is a 21-item questionnaire measuring depression, using a 0-3 Likert scale

  6. Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS)

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

    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.

  7. Change from baseline in the Life Satisfaction Questionnaire (LISAT-11)

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

    The LISAT-11 is an 11-item scale measuring satisfaction with different aspects of life and uses a 1-6 Numeric Rating Scale.

  8. Change from baseline in the PROMIS-29

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

    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.

  9. Change from baseline in the Multidimensional Assessment of Interoceptive Awareness 2 brief version (brief MAIA-2)

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

    The brief MAIA-2 is a 24-item scale measures different aspects of interoceptive awareness using a 0-5 Numeric Rating Scale.

  10. Change from baseline in the Perceived Stress Scale brief version

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

    The Perceived Stress Scale (brief version) is a 10-item scale measuring thoughts and feelings about stress using a 0-4 Likert Scale.

  11. Change from baseline in the Stress Mindset Measure (SMM)

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

    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.

  12. Change from baseline in the brief Existential Isolation Scale

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

    The EIS is a 6-item scale that measures social isolation as an existential experience, and uses a 0-9 Numeric Rating Scale.

  13. Change in the Working Alliance Inventory (WAI) throughout the course of Pain Reprocessing Therapy

    Time frame: Up to 6 hours after every 2 PRT sessions (assessed until the last PRT session, up to 4-6 weeks after enrolment)

    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.

  14. Life Orientation Test (LOT-R)

    Time frame: Baseline

    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.

Other outcomes

  1. Change from baseline in the Brief Pain Inventory (BPI) - Medication

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

    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.

  2. Change from baseline in the Brief Pain Inventory (BPI) - Body map

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

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Kristiania University College

Registry information

Official study title

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

Acronym: FOKUS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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