Suspendu

Feasibility and Acceptability of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Pain reprocessing therapy (PRT)

+ Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

+ Usual care

ComportementalAutre
Qui peut participer

Mal de dos+3

+ Manifestations Neurologiques

+ Douleur

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : avril 2023
Voir le détail du protocole

Résumé

Sponsor principalUniversity of Colorado, Denver
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 12 avril 2023

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielFeasibility and Acceptability of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
Sponsor principalUniversity of Colorado, Denver
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

150 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Mal de dosManifestations NeurologiquesDouleurSignes et symptômesConditions pathologiques, signes et symptômesDouleur Chronique

Critères

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

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

3 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
PRT has 5 components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend 1 assessment and education telehealth session with a physician followed by 8, 50-minute, therapist-led sessions. Pacing will be flexible, ranging from 5-12 weeks, to increase accessibility. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.

Groupe II

Comparateur actif
CBT-CP, considered the leading psychological treatment for chronic pain, is a structured, time-limited intervention that aims to teach patients how to better manage chronic pain and improve their quality of life. Participants will receive 9, 50-minute sessions of CBT-CP over 5 - 12 weeks. The VA CBT-CP protocol contains an initial orientation involving education and familiarization with the CBT-CP approach to chronic pain. The protocol then includes sessions that focus on topics such as exercise, relaxation, pleasant activities, cognitive coping, and sleep. All CBT-CP sessions will be remotely-delivered.

Groupe III

Comparateur actif
Participants will be asked to continue whatever they are already doing to care for their back pain. Length of the usual care condition will be 5 weeks, the expected mean completion time of the PRT and CBT arms, and may be adjusted at mid-enrollment to match treatment arm length more closely.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

University of Colorado Anschutz Medical Campus

Aurora, United StatesOuvrir University of Colorado Anschutz Medical Campus dans Google Maps
Suspendu1 Centres d'Étude