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Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture (SPOC_CBT)

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ClinicalTrials.gov Identifier: NCT03196258
Recruitment Status : Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Hamilton Academic Health Sciences Organization
Hamilton Health Sciences Corporation
St. Joseph Hospital Health Center
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. In order to study this relationship, researchers at McMaster University have developed the Somatic Pre-Occupation and Coping (SPOC) questionnaire, which identifies illness beliefs that may help to predict which patients are at risk for ongoing pain, reduced quality of life, and delays in returning to work and leisure activities after a fracture requiring surgical treatment. Previous research using the SPOC questionnaire suggests the possibility that fracture patients with illness beliefs that put them at risk for developing ongoing pain could be identified early in the treatment process. These patients may benefit from cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT is effective in reducing ongoing pain and improving quality of life in fracture patients who show illness beliefs that may place them at risk for developing ongoing pain.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Fractures, Closed Fractures, Open Behavioral: Cognitive behavioural therapy Not Applicable

Detailed Description:

In North America, chronic non-cancer pain affects approximately 30% of the population, with similar rates in Europe and Australia. Surgery and trauma are frequently cited as triggering events responsible for the development of chronic pain. A survey of 5,130 patients attending 10 outpatient clinics located throughout North Britain found that 41% attributed their chronic pain to a traumatic event or surgery. The presence of persistent pain can have a major impact on patients' quality of life, including their ability to return to work and their daily activities.

The relationship between psychological factors, behaviors, and cognitive processes and the sensation of pain is well documented. Stress, distress, anxiety, depression, catastrophizing, fear-avoidance behaviors, and poor coping strategies appear to have a significant positive relationship with both acute and chronic pain. Evidence suggests that these psychological factors can cause alterations along the spinal and supraspinal pain pathways which influence the perception of pain. Previous studies suggest that patients' beliefs and expectations may be associated with clinical outcomes, including self-reported pain.

Clinical outcomes following operatively managed fractures of the extremities are variable and many patients continue to experience persistent pain and disability one-year after surgery and beyond. In a recent trial involving patients with open extremity fractures, 65% of patients reported moderate to very severe pain and 35% reported moderate to extreme pain interference at one-year. A systematic review of 20 observational studies of traumatic tibial fracture repairs found the mean incidence of persistent post-surgical pain (PPSP) was 47.4% (range: 10% to 86%) at an average of 23.9 months after surgery. Although several risk factors for PPSP have been identified, many, such as younger age and female gender, are non-modifiable and thus not amendable to direct intervention.

The effect of patients' beliefs and expectations on their recovery following traumatic injuries is an under-investigated area. In response to this gap, Busse et al. developed and evaluated the Somatic Pre-Occupation and Coping (SPOC) questionnaire to identify unhelpful illness beliefs that are predictive of poorer functional outcomes post-fracture. This self-administered questionnaire identified unhelpful illness beliefs among approximately one third of patients with operatively managed extremity fractures. Furthermore, high somatic pre-occupation and poor coping at 6-weeks post-fracture (as measured by the SPOC questionnaire) were found to be strongly associated with PPSP, functional limitations, unemployment, and reduced quality of life 1 year after fracture fixation. This suggests the possibility that fracture patients who exhibit unhelpful illness beliefs can be identified and targeted for concurrent therapy designed to modify such cognitions and improve prognosis. At present, however, there are no approaches that have been shown effective for improving recovery among high-risk patients.

The findings from the FLOW trial highlight the importance of patient beliefs in recovery from orthopaedic trauma. A number of systematic reviews have shown patients' perceptions regarding their illness experience can be modified, and that such efforts can improve outcomes. Moss-Morris and colleagues explored the effect of CBT among patients attending a multidisciplinary chronic pain clinic and found that changes in cognitive processes accounted for 26% of the variation in improved health-related quality of life scores. Collectively, these findings suggest that targeting and modifying unhelpful beliefs through CBT may provide an effective strategy to improve outcomes among high-risk trauma patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants with operatively managed extremity fractures who screen positive for unhelpful illness beliefs (SPOC scores ≥78) 6-weeks post-fracture fixation will be randomized to receive either 6 weekly one-on-one, 1-hour sessions of cognitive behavioral therapy (CBT) or standard of care (control). Outcomes will be assessed at 3 months, 6 months, 9 months, and 12 months' post-fracture
Masking: None (Open Label)
Masking Description: Eligible participants will be randomized to 1 of 2 groups: 1) CBT intervention or 2) standard of care. Due to the nature of the intervention, it will not be feasible to blind participants, treating surgeons, or CBT therapists to treatment allocation. The data analyst and Steering Committee will be blinded to treatment allocation
Primary Purpose: Prevention
Official Title: Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures: A Randomized Controlled Trial (SPOC-CBT)
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: intervention - CBT
Participants in this arm will receive 6 weekly one-on-one, 1-hour sessions of Cognitive Behavioural Therapy session (intervention) in addition to receiving standard of care treatment for their fracture(s).
Behavioral: Cognitive behavioural therapy
Participants who are randomized to the CBT intervention are required to start CBT within 8 weeks of their fracture surgery. The CBT intervention will consist of 6 weekly one-on-one, 1-hour sessions that will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses on the SPOC questionnaire. All other aspects of post-operative care will be at the discretion of participant's surgeon
Other Name: CBT

No Intervention: control
Participants in the control arm of the study will receive standard of care treatment for their fracture(s) but will not receive any Cognitive Behavioral Therapy.



Primary Outcome Measures :
  1. The prevalence of Persistent Post-Surgical Pain at 12 months' post-fracture [ Time Frame: 12 months post-fracture ]

    The primary outcomes are 1) PPSP according to the World Health Organization's (WHO) proposed definition, and 2) the prevalence of moderate to severe pain interference over 12 months post-fracture as assessed by an individual item from the Patient-Reported Outcomes Measurement Information System (PROMIS).

    The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least two months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternative cause.



Secondary Outcome Measures :
  1. Short Form 12 (SF-12) [ Time Frame: 1 year ]
    General health related quality of life will be assessed by the SF-12. The SF-12 is an established, reliable and validated health status measure.It is a self-administered, 12-item questionnaire that measures health-related quality of life in 8 domains related to physical, social, mental, and emotional functioning, bodily pain, and general health. Both physical and mental summary scores can be obtained. Each domain is scored separately from 0 (lowest level) to 100 (highest level).

  2. Return to Function questionnaire [ Time Frame: 1 year ]
    Return to function will be measured by when participants' return to work, household activities, and leisure activities, as well as when they achieve 80% of their pre-injury function. The return to function outcome will be assessed using the Return to Function questionnaire.

  3. PROMIS-Physical Function 28 [ Time Frame: 1 year ]
    HRQL will also be assessed by the PROMIS-PF28, as recent research suggests it may be more sensitive to change than the SF-12. The PROMIS-PF is a standard for patient-reported outcomes research and practice and recommended for initial outcome assessment. Studies continue to support its construct validity and feasibility. The PROMIS-PF includes seven HRQoL domains: Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain. The PROMIS-Physical Function 28 will be used to assess seven health quality of life domains.


Other Outcome Measures:
  1. Exploratory outcome 1: Fracture healing complications [ Time Frame: 1 year ]
    fracture healing complications as assessed by the treating surgeon (including wound healing problems, infection (superficial and deep), hardware failure, hardware breakage, and non-union),

  2. Exploratory outcome 2: time to fracture healing [ Time Frame: 1 year ]
    time to clinical fracture healing, as assessed by the treating surgeon. To determine if CBT versus usual care reduces the incidence of fracture healing complications within 12-months post-fracture

  3. Exploratory outcome 3: opioid use [ Time Frame: 1 year ]
    Patient-reported use of opioid class medications. ) to determine if CBT versus usual care reduces the proportion of participants taking opioid class medications at 6 months and 12 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The inclusion criteria are:

  1. Adult men or women aged 18 years and older.
  2. Acute open or closed fracture(s) of the appendicular skeleton. Patients with multiple fractures may be included.
  3. Fracture treated operatively with internal fixation.
  4. Screened for eligibility within 6 weeks of their fracture.
  5. Cognitive ability and language skills required to participate in the CBT intervention (in the judgement of site research personnel).
  6. Able to start the CBT within 8 weeks of their fracture surgery.
  7. Provision of informed consent.
  8. Screen positive for unhelpful illness beliefs (SPOC scores ≥74), as assessed at 6 weeks' post-surgical fixation.

The exclusion criteria are:

  1. Fragility fracture.
  2. Stress fracture.
  3. Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture.
  4. Active psychosis.
  5. Active suicidality.
  6. Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the study.
  7. Already participating in, or planning to start other psychological treatments (including CBT) within the duration of the study (12 months).
  8. Anticipated problems with the patient attending CBT sessions and/or returning for follow-up.
  9. Incarceration.
  10. Other reason to exclude the patient, as specified.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196258


Contacts
Contact: Jason Busse, PhD 9055259140 ext 21731 bussejw@mcmaster.ca
Contact: Sheila Sprague, PhD 905-929-7846 sprags@mcmaster.ca

Locations
Canada, Ontario
St. Joseph Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Brad Petrisor, MD,MSc,FRCSC         
Contact: Sheila Sprague, PhD       sprags@mcmaster.ca   
Sub-Investigator: Sheila Sprague, PhD         
Sub-Investigator: Mohit Bhandari, MD,PhD,FRCSC         
Sponsors and Collaborators
McMaster University
Hamilton Academic Health Sciences Organization
Hamilton Health Sciences Corporation
St. Joseph Hospital Health Center

Additional Information:
Publications:

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03196258     History of Changes
Other Study ID Numbers: SPOC-CBT-001
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
fracture
persistent pain
cognitive behavioural therapy
post surgical pain
health-related quality of life

Additional relevant MeSH terms:
Fractures, Bone
Pain, Postoperative
Fractures, Closed
Fractures, Open
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms