The Development of a Cognitive Reassurance Training Program

NCT03256617 | Terminated

• 1 other identifier: 00100188
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

low back pain; cognitive reassurance; physical therapist training

Outcome Measures

Primary Outcomes (3)

• Change in back beliefs questionnaire for health care providers

  Measures providers' beliefs about back pain pre and post training

  Baseline, 5 days

• Low back pain vignettes

  Measures provider decision making related to cognitive reassurance

  End of 2nd day of therapist training

• Skills assessment

  Assess skills in the provision of cognitive reassurance during role-playing activity

  End of 2nd day of therapist training

Secondary Outcomes (7)

• Change in the Pain Catastrophizing Scale

  Baseline, 4 weeks and 8 weeks

• Change in fear the Avoidance Beliefs Questionnaire

  Baseline, 4 weeks and 8 weeks

• Change in the Pain Self-efficacy Questionnaire

  Baseline, 4 weeks and 8 weeks

• Change in the Back Beliefs Questionnaire

  Baseline, 4 weeks and 8 weeks

• Patient check list

  2 weeks following initial evaluation for low back pain by a physical therapist

Study Arms (1)

Provider training

EXPERIMENTAL

Other: Cognitive reassurance training

Interventions

Cognitive reassurance training OTHER

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.

Provider training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None
• 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
• Report being referred to physical therapy for specific low back pathology (e.g. fracture)
• Any lumbar surgery in the past 6 months
• Current pregnancy

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Care Out Patient Physical Therapy Clinics

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jake S Magel, PT, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Pre-post test design for the therapists followed by a prospective cohort of patients. We anticipate 50 physical therapy providers and 150 patients for a total of 200 participants.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 22, 2017
• Study Start: May 19, 2017
• Primary Completion: August 25, 2017
• Study Completion: November 8, 2018
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)