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- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in back beliefs questionnaire for health care providers
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in the Pain Catastrophizing Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 00100188
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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