Pain Reprocessing Therapy (PRT) in a Specialist Pain Clinic: A Feasibility Study

NCT07791355 | Recruiting

• 1 other identifier: 2026-01099-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave. For many people with long-term pain, there is no clear injury or disease that fully explains why it hurts. In these cases, the pain is believed to be caused by how the brain and nervous system process pain signals. This is sometimes called "nociplastic pain." Even though there are many treatments for pain-like medications and therapies-they don't work for everyone, and many people are left without meaningful relief. Because of this, it is important to find and test new ways to treat pain. In this study, the investigators evaluate a relatively new psychological treatment called Pain Reprocessing Therapy (PRT), which has been tested in the US with promising results. PRT helps individuals with chronic pain to understand and change how they think about their pain by explaining how the brain works. The treatment focuses on teaching the difference between acute (new) pain and long-term pain. It also involves exercises to help people alter emotions related to their pain. A key part of the treatment is a technique where patients practice paying attention to what is happening in their bodies in a safe, relaxed way. The goal is to teach the brain that the pain signals are not a threat. This can help break the vicious cycle of fear, avoiding activities, and worsening pain. While many people are interested in treatments like PRT, it hasn't yet been tested in specialized care for patients with complex pain. This trial is a pilot study-a smaller, initial investigation to evaluate how well the treatment works in a clinical setting, and to determine if both patients and therapists find it acceptable and practical to use. This will give us important information to help prepare for larger studies in the future. The main goal of this pilot study is to see if PRT is a practical and accepted treatment in a Swedish pain rehabilitation setting. The investigators also want to look at whether the treatment helps reduce pain, psychological distress, negative thoughts about pain, and the fear of moving. Finally, the investigators will explore how a patient's expectations and thinking skills (such as memory and focus) might affect how well the treatment works, and take physical measurements before and after the treatment to see if the nervous system becomes better at regulating pain.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Retention rate

  The retention rate is defined as the percentage of participants who successfully complete the PRT intervention. To be considered a completer, a participant must attend at least 6 of the 9 individual sessions and complete all post-treatment outcome measures. The benchmark for study feasibility is set at 75%

  From enrollment to 9 weeks (post treatment).

• Recruitment rate

  Feasibility of recruitment, defined as percentage of eligible participants who give informed consent and are enrolled in the study. The predefined benchmark for feasibility of recruitment rate is set as at least 70%

  From study start to recruitment completion, an estimated 6 months

• Patient treatment satisfaction

  Assessed using the Client Satisfaction Questionnaire (CSQ-8). The total score ranges from 8 to 32. Higher scores indicate greater satisfaction with the treatment received, representing a better outcome. The predefined benchmark for acceptability is set to a mean total score of 24 or higher (out of a maximum of 32).

  Post treatment (9 weeks)

• Adherence to treatment

  Adherence to the in-between session work with home assignments, as logged by the therapists during the 9-week program. The predefined benchmark for adequate adherence is at least 70% of assigned homework tasks.

  From enrollment to the end of the treatment at 9 weeks

• Therapists treatment fidelity

  The degree to which the therapists adhere to the core interventions of the treatment. Evaluated by therapist self-report using a study-specific PRT fidelity checklist completed after each session. The predefined benchmark for adequate treatment fidelity is set to an average adherence score of at least 80%.

  From treatment start to the end of treatment at 9 weeks

Secondary Outcomes (10)

• Pain Catastrophizing Scale (PCS)

  Baseline and week 9

• Tampa Scale of Kinesiophobia (TSK)

  Baseline and week 9

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and week 9

• EQ-5D

  Baseline and week 9 (post treatment)

• EQ-5D VAS

  Baseline to 9 week (post treatment)

Other Outcomes (7)

• Pressure Pain Threshold (PPT)

  Baseline and 9-week

• Thermal Pain Thresholds

  Baseline and week 9 (Post treatment)

• PrePain Questionnaire

  Before treatment start and 9 weeks (post treatment)

Study Arms (1)

Pain Reprocessing Therapy

EXPERIMENTAL

Behavioral: Pain Reprocessing Therapy

Interventions

Pain Reprocessing Therapy BEHAVIORAL

A 9-week intervention with 9 individual sessions and 3 group sessions based on Pain Reprocessing Therapy.

Pain Reprocessing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older.
• Completed medical investigation regarding the pain diagnosis. Primary pain conditions (according to ICD-11) or nociplastic pain, as well as mixed conditions where patients have nociplastic pain combined with nociceptive and/or neuropathic pain (e.g., fibromyalgia, chronic widespread pain, primary chronic back pain).
• Pain duration of at least 3 months.
• Current medication regimen compatible with participating in and benefiting from highly specialized rehabilitation.
• Ability to read, speak, and understand the Swedish language.

You may not qualify if:

• Severe psychiatric conditions (e.g., psychosis, severe depression, and suicidality).
• Current substance abuse (including overuse of prescription medications) or dementia.
• Cancer pain, cauda equina syndrome, or other medical conditions that constitute the primary explanation for the patient's pain.
• Another psychological treatment for pain within the past 3 months.
• Ongoing parallel treatments related to the patient's pain at other clinics, with the exception of ongoing pharmacological treatment.
• Ongoing legal disputes or active claims for disability compensation.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: For exploratory purpouses, this pilot study will utilize a matched reference group drawn from the Swedish Quality Registry for Pain Rehabilitation.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)