Clinical trial NCT03256617: 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
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
cognitive reassurance
physical therapist training
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Change in back beliefs questionnaire for health care providers
timeFrame: Baseline, 5 days
measure: Low back pain vignettes
timeFrame: End of 2nd day of therapist training
measure: Skills assessment
timeFrame: End of 2nd day of therapist training
Secondary outcomes:
measure: Change in the Pain Catastrophizing Scale
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change in fear the Avoidance Beliefs Questionnaire
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change in the Pain Self-efficacy Questionnaire
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change in the Back Beliefs Questionnaire
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Patient check list
timeFrame: 2 weeks following initial evaluation for low back pain by a physical therapist
measure: Open-ended question
timeFrame: 2 weeks following the initial evaluation for low back pain by a physical therapist
measure: Provider check list
timeFrame: 2 weeks status post initial evaluation of patient with low back pain
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Care Out Patient Physical Therapy Clinics
state: Utah
Study officials:
affiliation: University of Utah
name: Jake S Magel, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: