Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)

NCT03335657 | Completed DMC

• 1 other identifier: W81XWH-16-2-0060
• Study Type: interventional
• Target: 633
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of the CBPT study is to determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury. Primary outcome is physical function measured through a patient-reported questionnaire and physical performance tests. Secondary outcomes include pain and general health. Tertiary outcome is return to work/duty.

Conditions

Lower Extremity Injury

Outcome Measures

Primary Outcomes (1)

• Physical Function- self-reported capability to carry out activities

  Physical Function measured through Patient Reported Outcome Measurement Information System (PROMIS)/ Physical Function (short form) domain to assess one's ability to carry out activities that require a combination of skills, often within a social context. This instrument has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 40 which represents the worse outcome. The lowest possible score is 8 and it represents the better outcome.

  12 months

Secondary Outcomes (6)

• Pain_ self reported

  12 months

• General Health

  12 months

• Physical Function- Balance and Agility

  12 months

• Physical Function- Mobility and Power

  12 months

• Physical Function-Leg Strength, Endurance, and Mobility

  12 months

Other Outcomes (1)

• Return to work/duty

  6 months

Study Arms (2)

CBPT Treatment

EXPERIMENTAL

The CBPT intervention delivers a patient-oriented cognitive-behavioral self-management program to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy. The program consists of six weekly telephone sessions with a trained physical therapist. Sessions cover an introduction and rationale for treatment in addition to techniques such as deep breathing, graded activity plan and goal-setting, distraction techniques, automatic thoughts, coping self-statements, being present-minded, and relapse prevention and symptom management plans. At the end of the 6th week, patients will build individualized recovery plans with selected strategies and details on frequency of practice.

Other: CBPT

Education Treatment

PLACEBO COMPARATOR

The education program provides a postoperative recovery and is based on education that would typically be provided by a treating physician or a physical therapist in an outpatient setting. The education program is matched to the CBPT treatment in terms of session frequency and contact with the study therapist. The therapist will call weekly to check in with the patient and encourage him/her to read the manual. Manuals contain educational information on injury patterns and symptoms, stress and recovery, benefits of physical therapy, and importance of daily exercise, and ways to promote healing. Education on sleep hygiene, energy management, healthy eating, and preventing future injury are also provided.

Other: Education Treatment

Interventions

CBPT OTHER

The CBPT program focuses on a patient-oriented cognitive-behavioral self-management approach to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy.

CBPT Treatment

Education Treatment OTHER

Participants receiving the education control arm are receiving a placebo intervention to control for the attention of the interventionist. They will receive standardized educational material addressing recovery from orthopaedic trauma.

Education Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-60 yrs inclusive
• Patients with at least one acute orthopaedic injury to the lower extremities or pelvis/acetabulum (determination based on information available at the time of enrollment).
• Injury resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, fall \> 10 ft, gun shot, blunt trauma)
• Patients receiving operative fixation for one or more acute orthopaedic injuries at a participating hospital. Patients should be recruited at the time of primary injury, not revision or complication surgery
• Presence of psychosocial risk factors for poor outcomes (defined as a score greater than 30 on the Pain Catastrophizing Scale (PCS) or a score equal to or greater than 39 on the Tampa Scale for Kinesiophobia (TSK) or a score equal to or less than 40 on the Pain Self Efficacy Scale (PSES)). These risk factors will be identified between 2 and 8 weeks after hospital discharge.

You may not qualify if:

• Non-English speaking
• Patients who are unable to start the program within 12 weeks of discharge from hospital because of multiple readmission, admission to a rehabilitation facility, or other extenuating circumstances
• Patients with moderate or severe traumatic brain injury (TBI), as evidenced by intracranial hemorrhage present on admission CT. If no CT performed, patient assumed not to have moderate or severe TBI
• Patients with major amputations of the upper or lower extremities (great toe, thumb, or proximal to the wrist or ankle)
• Patients who require a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
• Patients non-ambulatory pre-injury or due to an associated spinal cord injury
• History of dementia or Alzheimer's disease based on medical record or patient self-report
• History of neurological disorder, disease or event, resulting in prior cognitive and/or physical impairment, such as prior TBI or stroke based on medical record or patient self-report
• Presence of schizophrenia or other psychotic disorder based on medical record or patient self-report
• Current alcohol and/or drug addiction based on medical record or patient self-report
• Severe problems with maintaining follow-up expected (e.g. patients who are incarcerated or homeless)

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (8)

Florida Orthopaedic Institute

Tampa, Florida, 33606, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 20742, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas Health Science Center at Houston Medical School

Houston, Texas, 78229, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78434, United States

Location

Related Publications (1)

• Archer KR, Davidson CA, Alkhoury D, Vanston SW, Moore TL, Deluca A, Betz JF, Thompson RE, Obremskey WT, Slobogean GP, Melton DH, Wilken JM, Karunakar MA, Rivera JC, Mir HR, McKinley TO, Frey KP, Castillo RC, Wegener ST; METRC. Cognitive-Behavioral-Based Physical Therapy for Improving Recovery After Traumatic Orthopaedic Lower Extremity Injury (CBPT-Trauma). J Orthop Trauma. 2022 Jan 1;36(Suppl 1):S1-S7. doi: 10.1097/BOT.0000000000002283.

  PMID: 34924512 DERIVED

Study Officials

• Kristin Swygert, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Katherine Frey, PhD

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 8, 2017
• Study Start: July 18, 2018
• Primary Completion: June 18, 2021
• Study Completion: July 18, 2021
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)