Feasibility and Acceptability of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
Pain reprocessing therapy (PRT)
+ Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
+ Usual care
Mal de dos+3
+ Manifestations Neurologiques
+ Douleur
Étude thérapeutique
Résumé
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.
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.150 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.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
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.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifGroupe III
Comparateur actifObjectifs 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
University of Colorado Anschutz Medical Campus
Aurora, United StatesOuvrir University of Colorado Anschutz Medical Campus dans Google Maps