The Development of a Cognitive Reassurance Training Program

Low Back Pain Clinical Trial

Official title:

The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03256617
• Other study ID #: 00100188
• Status: Terminated
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: November 8, 2018

Study information

• Verified date: April 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: November 8, 2018
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Cognitive reassurance 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.

Locations

Country	Name	City	State
United States	University of Utah Health Care Out Patient Physical Therapy Clinics	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in back beliefs questionnaire for health care providers	Measures providers' beliefs about back pain pre and post training	Baseline, 5 days
Primary	Low back pain vignettes	Measures provider decision making related to cognitive reassurance	End of 2nd day of therapist training
Primary	Skills assessment	Assess skills in the provision of cognitive reassurance during role-playing activity	End of 2nd day of therapist training
Secondary	Change in the Pain Catastrophizing Scale	Measure of patient's pain catastrophizing	Baseline, 4 weeks and 8 weeks
Secondary	Change in fear the Avoidance Beliefs Questionnaire	Measure of patient's fear-avoidance beliefs.	Baseline, 4 weeks and 8 weeks
Secondary	Change in the Pain Self-efficacy Questionnaire	Measure of patient's pain self-efficacy	Baseline, 4 weeks and 8 weeks
Secondary	Change in the Back Beliefs Questionnaire	Measure of patient's back beliefs	Baseline, 4 weeks and 8 weeks
Secondary	Patient check list	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
Secondary	Open-ended question	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
Secondary	Provider check list	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