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The Development of a Cognitive Reassurance Training Program

14 de abril de 2020 atualizado por: 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.

Visão geral do estudo

Status

Rescindido

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

Intervencional

Inscrição (Real)

128

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
        • University of Utah Health Care Out Patient Physical Therapy Clinics

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
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.

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
Measures providers' beliefs about back pain pre and post training
Baseline, 5 days
Low back pain vignettes
Prazo: End of 2nd day of therapist training
Measures provider decision making related to cognitive reassurance
End of 2nd day of therapist training
Skills assessment
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in the Pain Catastrophizing Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline, 4 weeks and 8 weeks
Measure of patient's back beliefs
Baseline, 4 weeks and 8 weeks
Patient check list
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de maio de 2017

Conclusão Primária (Real)

25 de agosto de 2017

Conclusão do estudo (Real)

8 de novembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

8 de agosto de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de agosto de 2017

Primeira postagem (Real)

22 de agosto de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de abril de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de abril de 2020

Última verificação

1 de abril de 2020

Mais Informações

Termos relacionados a este estudo

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)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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