Pain Reprocessing Therapy for Chronic Widespread Pain - A Randomized Multiple-baseline SCED Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change from baseline in the Brief Pain Inventory (BPI) - Pain interference
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Pain Reprocessing Therapy (Behavioral)
Outcomes
Primary Outcomes
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.
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).
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.
Secondary Outcomes
- Change from baseline in the Pain Coping Questionnaire - short form(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the State-Trait Anxiety Inventory (State questionnaire only)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the Becks Depression Inventory II (BDI-2)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the brief Existential Isolation Scale(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the Pain Catastrophizing Scale (PCS)(From enrolment to the end of treatment at 4-6 weeks)
- Life Orientation Test (LOT-R)(Baseline)
- Change from baseline in the Generalized Anxiety Disorder Assessment (GAD-7)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the Life Satisfaction Questionnaire (LISAT-11)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the Stress Mindset Measure (SMM)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the PROMIS-29(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)(From enrolment to the end of treatment at 4-6 weeks)
- Change from baseline in the Perceived Stress Scale brief version(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(Up to 6 hours after every 2 PRT sessions (assessed until the last PRT session, up to 4-6 weeks after enrolment))
Investigators
Dan-Mikael Ellingsen
Professor of Psychology
Oslo University Hospital