Clinical trial NCT05820204: Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
Official title: Feasibility and Acceptability of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Back Pain
Keywords: chronic pain
Pain Reprocessing Therapy
Cognitive Behavioral Therapy for Chronic Pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm randomized control trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn which treatment works better for adults with chronic pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain).

The study's main questions are:

* Does PRT work well for adults with chronic pain?
* Which treatment works better for lowering pain: PRT, CBT, or usual care?

This study will compare PRT, CBT, and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain can have.

Detailed description: Investigators recently developed a novel psychological treatment, pain reprocessing therapy (PRT). Using a combination of cognitive, exposure-based, and somatic psychotherapy techniques, PRT aims to promote patients' reconceptualization of pain as due to reversible, non-dangerous brain activity rather than peripheral pathology. Critically, PRT aims to reduce or eliminate pain, rather than increasing functioning.

In the first trial of PRT (N = 151), 66% of patients randomized to PRT were pain-free or nearly so at post-treatment, as compared to fewer than 20% of placebo and usual care controls. This trial was conducted in a primarily White, highly-educated population with face-to-face treatment, and how PRT effects would generalize to a more diverse population or to telehealth treatment is not known.

PRT was developed to better address pain intensity and pain-related outcomes compared to leading psychological treatments for pain such as cognitive behavioral therapy (CBT). This study aims to yield preliminary findings on the comparative efficacy of PRT vs. CBT vs. usual care. Developing scalable effective, non-pharmacological chronic pain treatments and testing their efficacy in racial/ethnic minorities is an urgent societal need. Accordingly, this study also tests a remotely-delivered PRT intervention in a diverse patient population.

Aim 1 of this study is to test the feasibility (recruitment \& retention) of conducting a randomized clinical trial comparing remotely-delivered PRT with an active comparator, CBT, and usual care and to assess the acceptability (helpfulness, satisfaction, \& impact) of PRT in a diverse, lower socioeconomic status (SES) patient population.

Aim 2 of this study is to test the comparative efficacy of PRT vs. CBT and PRT vs. usual care on pain intensity and other pain-related outcomes.

Additional resources became available during the study, allowing an increase in sample size from N = 75 to N = 150 to provide greater statistical power aim 2 (comparative efficacy). No interim analyses were conducted at any point, and investigators remained blind to study outcomes. The decision to expand the sample size was made after careful deliberation with Columbia and Cornell Roybal Center Advisory Committees.

Eligibility criteria: Inclusion Criteria:

* Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)
* Back pain that is an ongoing problem for at least half the days of the last 6 months
* Back pain that is worse than leg pain.

Exclusion Criteria:

* Current litigation or compensation associated with pain or plans to apply for compensation or engage in litigation in the next 6 months
* Active suicidal ideation with intent, recent history of suicide attempt, or recent history of suicide attempts or self-harm behaviors within the past 5 years (including non-suicidal self-harm)
* Recent history of inpatient psychiatric hospitalization within the past 5 years
* Active, current psychosis or mania
* Active, current substance abuse, or problems with substance abuse within the past 2 years
* Instability in living conditions or major interfering life events:

  * Major surgery or other major medical event planned in coming six months
  * Unsure whether will reliably have suitable conditions for telehealth appointments over the next two months, including a computer or tablet, reliable fast internet, and a quiet comfortable room that is reliably available.
  * Major, interfering changes in employment or housing anticipated over the next six months
* Failure to complete at least 85% (6 of 7) of EMA surveys in the first week of the study (post-consent, pre-randomization)
* Leg pain worse than back pain
* Back surgery within the last 2 years
* Difficulty controlling bladder function (to screen out cauda equina syndrome)
* Serious medical illness (e.g., current, or recent cancer diagnosis, severe cardiovascular disease)
* Recent large unexplained, unintended weight loss (20lbs or more)
* Recent vertebral fracture/ known spinal fractures or tumors
* Known sensory/motor abnormalities in the trunk or legs.
* Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis

Primary outcomes:
measure: Pain intensity
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Session Attendance
timeFrame: This value will be calculated a day after post-treatment for the last participant, approximately 1 year from the start of enrollment
Secondary outcomes:
measure: Pain interference
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Depression
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Positive Affect
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Anxiety
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Anger
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Sleep quality
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Client satisfaction
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Physical Activity Levels
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
measure: Medication Use
timeFrame: Primary time point is the day after post-treatment, 1.5 months on average
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jonathan K. Ashar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: