Lower Extremity InjuryCBPTNCT03335657
Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
A study testing CBPT and Education Treatment in people with Lower Extremity Injury, run by Major Extremity Trauma Research Consortium at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Extremity Injury
- What is being tested?
- CBPT and Education Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 633 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Jul 2018to 18 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 20742
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Carolinas Medical Center
Charlotte, North Carolina, 28203
The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 78229
Methodist Hospital
Indianapolis, Indiana, 46202
Vanderbilt Medical Center
Nashville, Tennessee, 37232
San Antonio Military Medical Center
San Antonio, Texas, 78434
Florida Orthopaedic Institute
Tampa, Florida, 33606
About this study
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.
Read the detailed description
Following extremity injury, referral (and direct access) to physical therapy (PT) is considered standard of care. And, while PT strategies are commonly impairment focused, clinicians across multiple subspecialties of physical therapy recognize the importance of addressing pain and pain-related psychosocial factors as strong predictors of chronic pain as well as long-term physical and psychological disability.
Cognitive-behavioral therapy (CBT) interventions have documented positive influence on psychosocial factors in patients with chronic pain. CBT-based self-management programs have also demonstrated improvement in patient outcomes and the adoption of a physically active lifestyle, as well as improvement in fear-avoidance beliefs and self-efficacy, in various populations with chronic conditions. These evidence-based CBT and self-management strategies provide the basis for the study intervention.
The proposed project will conduct a multi-center, randomized controlled trial to determine the efficacy of the CBPT program in patients at-risk for poor outcomes following traumatic lower-extremity injury. Central hypothesis is that delivery of CBPT by physical therapists over the telephone will improve outcomes, through reductions in pain catastrophizing and fear of movement and improvement in pain self-efficacy. The investigators propose a large, rigorous evaluation of the CBPT program in patients with lower extremity trauma with the goal of engaging civilians and service members in their own care and improving pain and functional outcomes.
Specific Aim 1 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. Secondary outcomes include physical performance tests, pain and general health. Tertiary outcome is return to work/duty.
Specific Aim 2 To determine whether changes in the intermediary outcomes of pain catastrophizing, fear of movement, and self-efficacy at 6 months are associated with improvement in outcomes 12 months after hospital discharge.
Specific Aim 3 To determine whether subgroups of patients are more likely to benefit from the CBPT program.
Specific Aim 4 To examine the value of CBPT relative to Education using Markov decision-analysis.
- Conditions
- Lower Extremity Injury
- Being tested
- CBPT, Education Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBPTOther
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.
Education TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Pain_ self reported
Pain measured through Patient Reported Outcome Measurement Information System (PROMIS)/ Pain Intensity (short form) Domain at 12-months following hospital discharge. This tool 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 15 which represents the worse outcome. The lowest possible score is 3 and it represents the better outcome.
Measured: 12 months
General Health
General Health measured through the Veterans RAND 12 Item Health Survey (VR-12)/ General Health Domain at 12-months following hospital discharge. This instrument has five response options ranging in value from one to five for each question. The total raw score is the sum of the values of the responses for each question. The highest possible raw score is 60, which represents the better outcome. The lowest possible score is 12, and it represents the worse outcome.
Measured: 12 months
Physical Function- Balance and Agility
Balance and Agility measured through the Four Square Step test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.
Measured: 12 months
Physical Function- Mobility and Power
Mobility and Power measured through the Timed Stair Ascent test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.
Measured: 12 months
Physical Function-Leg Strength, Endurance, and Mobility
Leg Strength, Endurance, and Mobility measured through the Sit to Stand Five Times
Measured: 12 months
Physical Function- Gait Speed
Gait Speed measured through 10-Meter Walk test. Each individual will have time scores
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start18 Jul 2018
- Primary completion18 Jun 2021
- Study completion18 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Swygert, PhD, Principal investigator, Vanderbilt University Medical CenterKatherine Frey, PhD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335657
- Sponsor's protocol ID
- W81XWH-16-2-0060
- Acronym
- CBPT
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2017
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34924512
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
- ClinicalTrials.gov ID
- NCT03335657
- Acronym / sponsor ID
- CBPT / W81XWH-16-2-0060
- Conditions
- Lower Extremity Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jul 2021 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following extremity injury, referral (and direct access) to physical therapy (PT) is considered standard of care. And, while PT strategies are commonly impairment focused, clinicians across multiple subspecialties of physical therapy recognize the importance of addressing pain and pain-related psychosocial factors as strong predictors of chronic pain as well as long-term physical and psychological disability.
Cognitive-behavioral therapy (CBT) interventions have documented positive influence on psychosocial factors in patients with chronic pain. CBT-based self-management programs have also demonstrated improvement in patient outcomes and the adoption of a physically active lifestyle, as well as improvement in fear-avoidance beliefs and self-efficacy, in various populations with chronic conditions. These evidence-based CBT and self-management strategies provide the basis for the study intervention.
The proposed project will conduct a multi-center, randomized controlled trial to determine the efficacy of the CBPT program in patients at-risk for poor outcomes following traumatic lower-extremity injury. Central hypothesis is that delivery of CBPT by physical therapists over the telephone will improve outcomes, through reductions in pain catastrophizing and fear of movement and improvement in pain self-efficacy. The investigators propose a large, rigorous evaluation of the CBPT program in patients with lower extremity trauma with the goal of engaging civilians and service members in their own care and improving pain and functional outcomes.
Specific Aim 1 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. Secondary outcomes include physical performance tests, pain and general health. Tertiary outcome is return to work/duty.
Specific Aim 2 To determine whether changes in the intermediary outcomes of pain catastrophizing, fear of movement, and self-efficacy at 6 months are associated with improvement in outcomes 12 months after hospital discharge.
Specific Aim 3 To determine whether subgroups of patients are more likely to benefit from the CBPT program.
Specific Aim 4 To examine the value of CBPT relative to Education using Markov decision-analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBPT Treatment | Experimental | Other: CBPTThe 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. |
| Education Treatment | Placebo comparator | Other: Education TreatmentThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBPTThe 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. | Other | CBPT Treatment |
| Education TreatmentParticipants 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. | Other | Education Treatment |
Primary outcome
Physical Function- self-reported capability to carry out activities
Time frame: 12 months
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.
6 secondary outcomes
Pain_ self reported
Time frame: 12 months
General Health
Time frame: 12 months
Physical Function- Balance and Agility
Time frame: 12 months
Physical Function- Mobility and Power
Time frame: 12 months
Physical Function-Leg Strength, Endurance, and Mobility
Time frame: 12 months
Physical Function- Gait Speed
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 34924512Archer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Swygert, PhD principal investigator
Vanderbilt University Medical Center
Katherine Frey, PhD study director
Johns Hopkins University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBPT and Education Treatment in people with Lower Extremity Injury, run by Major Extremity Trauma Research Consortium at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function- self-reported capability to carry out activities (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.