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The Development of a Cognitive Reassurance Training Program

14 avril 2020 mis à jour par: Jake Magel, University of Utah

The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes

The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training program by examining changes in physical therapist low back pain beliefs and skills with training and evaluating the quality with which physical therapists apply cognitive reassurance to patients. The secondary focus is to examine the association between physical therapist application of cognitive reassurance and short-term changes in patients' low back pain beliefs and expectations.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

Identifying strategies to favorably alter unhelpful cognitions of patients with recent onset low back pain is a research priority and could help curb the transition from acute to chronic low back pain; lessening the need for prolonged and costly management. Current evidence suggests that psychological factors, including maladaptive pain beliefs and avoidant behaviors and expectations for recovery, are associated with poor outcomes in patients with low back pain. Recently, considerable attention has been given to training non-psychologists to provide psychologically based interventions for patients with low back pian. A recent review of interventions that included psychological approaches noted that all of the trials that failed to show benefit included delivery of the intervention by non-psychologists. Authors suggest that increasing the effort in selecting, training, supervising and assessing the competence of the practitioners delivering the treatment could improve results.

Low back pain comprises approximately 50% of the caseload of outpatient physical therapists physical therapists making physical therapists ideally positioned to manage the unhelpful cognitions of patients with low back pain. However, physical therapists often feel unprepared when managing the cognitive factors associated with low back pain. The purpose of this project is to develop and assess the effectiveness of a training program for physical therapists that focuses on cognitive reassurance; a novel cognitive intervention for patients with low back pain.

Cognitive reassurance is a communication approach in which maladaptive beliefs and expectations are identified. Tailored explanations for the patient's conditions are then provided, possible prognosis and treatment are discussed, and clarifications are offered. With adequate training, physical therapists could utilize cognitive reassurance to promote patients' understanding of his/her condition and modify maladaptive low back pain-related beliefs and expectations.

The proposed pilot study will use a pre-post design to examine the impact of cognitive reassurance training on the low back pain beliefs and skills in physical therapists and physical therapist assistants. Following the training the investigators will recruit patients who have scheduled an evaluation for low back pain with the physical therapists who attended the training. Patient data will be collected at baseline before the evaluation and follow up data at 2, 4 and 8 weeks.

The specific aims are: 1) Evaluate the feasibility of a cognitive reassurance training program for physical therapists that focuses on modifying physical therapists' beliefs and improving physical therapists' skill in the application of cognitive reassurance for patients with acute/subacute low back pain. 2) Evaluate the application of cognitive reassurance by physical therapists to patients with acute/sub-acute low back pain. 3) Examine the association between physical therapist application of cognitive reassurance and short-term changes in the patient's low back pain beliefs and expectations (low back pain beliefs, self-efficacy, pain catastrophizing, fear-avoidance).

Type d'étude

Interventionnel

Inscription (Réel)

128

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Utah
      • Salt Lake City, Utah, États-Unis, 84132
        • University of Utah Health Care Out Patient Physical Therapy Clinics

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Therapist inclusion criteria:

  • University of Utah Health Care physical therapists and physical therapist assistants
  • Employed at least 20 hours a week
  • Licensed in the state of Utah

Therapist exclusion criteria:

  • None

Patient inclusion criteria

  • Primary reason for scheduling an evaluation with a physical therapist is low back pain (defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without referral in to one or both legs
  • Current episode of low back pain ≤ 12 weeks duration
  • Age 18-64
  • Ability to read and speak English

Patient exclusion criteria

  • Report being referred to physical therapy for specific low back pathology (e.g. fracture)
  • Any lumbar surgery in the past 6 months
  • Current pregnancy

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Provider training
The 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities. The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain. The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain. The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in back beliefs questionnaire for health care providers
Délai: Baseline, 5 days
Measures providers' beliefs about back pain pre and post training
Baseline, 5 days
Low back pain vignettes
Délai: End of 2nd day of therapist training
Measures provider decision making related to cognitive reassurance
End of 2nd day of therapist training
Skills assessment
Délai: End of 2nd day of therapist training
Assess skills in the provision of cognitive reassurance during role-playing activity
End of 2nd day of therapist training

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in the Pain Catastrophizing Scale
Délai: Baseline, 4 weeks and 8 weeks
Measure of patient's pain catastrophizing
Baseline, 4 weeks and 8 weeks
Change in fear the Avoidance Beliefs Questionnaire
Délai: Baseline, 4 weeks and 8 weeks
Measure of patient's fear-avoidance beliefs.
Baseline, 4 weeks and 8 weeks
Change in the Pain Self-efficacy Questionnaire
Délai: Baseline, 4 weeks and 8 weeks
Measure of patient's pain self-efficacy
Baseline, 4 weeks and 8 weeks
Change in the Back Beliefs Questionnaire
Délai: Baseline, 4 weeks and 8 weeks
Measure of patient's back beliefs
Baseline, 4 weeks and 8 weeks
Patient check list
Délai: 2 weeks following initial evaluation for low back pain by a physical therapist
Measure whether key messages of cognitive reassurance were perceived by the patient.
2 weeks following initial evaluation for low back pain by a physical therapist
Open-ended question
Délai: 2 weeks following the initial evaluation for low back pain by a physical therapist
Asks the patient to list the most important things they learned learned in physical therapy
2 weeks following the initial evaluation for low back pain by a physical therapist
Provider check list
Délai: 2 weeks status post initial evaluation of patient with low back pain
Measures whether key cognitive reassurance messages were provided to the patient by the provider
2 weeks status post initial evaluation of patient with low back pain

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Jake S Magel, PT, PhD, University of Utah

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 mai 2017

Achèvement primaire (Réel)

25 août 2017

Achèvement de l'étude (Réel)

8 novembre 2018

Dates d'inscription aux études

Première soumission

8 août 2017

Première soumission répondant aux critères de contrôle qualité

19 août 2017

Première publication (Réel)

22 août 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 avril 2020

Dernière vérification

1 avril 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 00100188

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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