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The Development of a Cognitive Reassurance Training Program

Primary Purpose

Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive reassurance training
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Back Pain focused on measuring low back pain, cognitive reassurance, physical therapist training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Utah Health Care Out Patient Physical Therapy Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Provider training

Arm Description

Outcomes

Primary Outcome Measures

Change in back beliefs questionnaire for health care providers
Measures providers' beliefs about back pain pre and post training
Low back pain vignettes
Measures provider decision making related to cognitive reassurance
Skills assessment
Assess skills in the provision of cognitive reassurance during role-playing activity

Secondary Outcome Measures

Change in the Pain Catastrophizing Scale
Measure of patient's pain catastrophizing
Change in fear the Avoidance Beliefs Questionnaire
Measure of patient's fear-avoidance beliefs.
Change in the Pain Self-efficacy Questionnaire
Measure of patient's pain self-efficacy
Change in the Back Beliefs Questionnaire
Measure of patient's back beliefs
Patient check list
Measure whether key messages of cognitive reassurance were perceived by the patient.
Open-ended question
Asks the patient to list the most important things they learned learned in physical therapy
Provider check list
Measures whether key cognitive reassurance messages were provided to the patient by the provider

Full Information

First Posted
August 8, 2017
Last Updated
April 14, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03256617
Brief Title
The Development of a Cognitive Reassurance Training Program
Official Title
The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruiting beyond September 10, 2018 would mean that the training occurred more than a year in the past. For this reason, we terminated recruitment.
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, cognitive reassurance, physical therapist training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cognitive reassurance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in back beliefs questionnaire for health care providers
Description
Measures providers' beliefs about back pain pre and post training
Time Frame
Baseline, 5 days
Title
Low back pain vignettes
Description
Measures provider decision making related to cognitive reassurance
Time Frame
End of 2nd day of therapist training
Title
Skills assessment
Description
Assess skills in the provision of cognitive reassurance during role-playing activity
Time Frame
End of 2nd day of therapist training
Secondary Outcome Measure Information:
Title
Change in the Pain Catastrophizing Scale
Description
Measure of patient's pain catastrophizing
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change in fear the Avoidance Beliefs Questionnaire
Description
Measure of patient's fear-avoidance beliefs.
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change in the Pain Self-efficacy Questionnaire
Description
Measure of patient's pain self-efficacy
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change in the Back Beliefs Questionnaire
Description
Measure of patient's back beliefs
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Patient check list
Description
Measure whether key messages of cognitive reassurance were perceived by the patient.
Time Frame
2 weeks following initial evaluation for low back pain by a physical therapist
Title
Open-ended question
Description
Asks the patient to list the most important things they learned learned in physical therapy
Time Frame
2 weeks following the initial evaluation for low back pain by a physical therapist
Title
Provider check list
Description
Measures whether key cognitive reassurance messages were provided to the patient by the provider
Time Frame
2 weeks status post initial evaluation of patient with low back pain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jake S Magel, PT, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health Care Out Patient Physical Therapy Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Development of a Cognitive Reassurance Training Program

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