- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03256617
The Development of a Cognitive Reassurance Training Program
The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah Health Care Out Patient Physical Therapy Clinics
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Provider training
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in back beliefs questionnaire for health care providers
Periodo de tiempo: Baseline, 5 days
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Measures providers' beliefs about back pain pre and post training
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Baseline, 5 days
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Low back pain vignettes
Periodo de tiempo: End of 2nd day of therapist training
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Measures provider decision making related to cognitive reassurance
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End of 2nd day of therapist training
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Skills assessment
Periodo de tiempo: End of 2nd day of therapist training
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Assess skills in the provision of cognitive reassurance during role-playing activity
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End of 2nd day of therapist training
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in the Pain Catastrophizing Scale
Periodo de tiempo: Baseline, 4 weeks and 8 weeks
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Measure of patient's pain catastrophizing
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Baseline, 4 weeks and 8 weeks
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Change in fear the Avoidance Beliefs Questionnaire
Periodo de tiempo: Baseline, 4 weeks and 8 weeks
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Measure of patient's fear-avoidance beliefs.
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Baseline, 4 weeks and 8 weeks
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Change in the Pain Self-efficacy Questionnaire
Periodo de tiempo: Baseline, 4 weeks and 8 weeks
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Measure of patient's pain self-efficacy
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Baseline, 4 weeks and 8 weeks
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Change in the Back Beliefs Questionnaire
Periodo de tiempo: Baseline, 4 weeks and 8 weeks
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Measure of patient's back beliefs
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Baseline, 4 weeks and 8 weeks
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Patient check list
Periodo de tiempo: 2 weeks following initial evaluation for low back pain by a physical therapist
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Measure whether key messages of cognitive reassurance were perceived by the patient.
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2 weeks following initial evaluation for low back pain by a physical therapist
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Open-ended question
Periodo de tiempo: 2 weeks following the initial evaluation for low back pain by a physical therapist
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Asks the patient to list the most important things they learned learned in physical therapy
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2 weeks following the initial evaluation for low back pain by a physical therapist
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Provider check list
Periodo de tiempo: 2 weeks status post initial evaluation of patient with low back pain
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Measures whether key cognitive reassurance messages were provided to the patient by the provider
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2 weeks status post initial evaluation of patient with low back pain
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jake S Magel, PT, PhD, University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 00100188
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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