- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Utah
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Salt Lake City, Utah, 미국, 84132
- University of Utah Health Care Out Patient Physical Therapy Clinics
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in back beliefs questionnaire for health care providers
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in the Pain Catastrophizing Scale
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Jake S Magel, PT, PhD, University of Utah
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 00100188
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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