Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-15 @ 6:11 AM
Study NCT ID:
NCT03673358
Status:
TERMINATED
Last Update Posted:
2020-01-29
First Post:
2018-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D005597', 'term': 'Fractures, Open'}, {'id': 'D005596', 'term': 'Fractures, Closed'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Participants with operatively managed extremity fractures 2-12 weeks post-fracture fixation will be randomized to receive either cognitive behavioural therapy (CBT) with participants having a choice of 6 weekly one-on-one telephone or video therapy sessions OR completion of online therapy modules or standard of care (control). Outcomes will be assessed at 3 months, 6 months, 9 months, and 12 months' post-fracture"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'whyStopped': 'Low compliance with CBT, and challenges with the CBT provider. Previous participants will be considered the pilot phase.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture", 'timeFrame': '12 months post-fracture', 'description': "The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition.\n\nThe 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 three 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."}], 'secondaryOutcomes': [{'measure': 'Short Form 36 (SF-36)', 'timeFrame': '12 months post-fracture', 'description': 'General health related quality of life will be assessed by the SF-36. The SF-36 is an established, reliable and validated health status measure. It is a self-administered, 36-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).'}, {'measure': 'Return to Function questionnaire', 'timeFrame': '12 months post-fracture', 'description': "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."}, {'measure': 'BPI-SF', 'timeFrame': '12 months post-fracture', 'description': 'The Brief Pain Inventory (BPI) assess pain severity and its impact on function'}, {'measure': 'Opioid Use', 'timeFrame': '12 months post-fracture', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Fractures, Open', 'Fractures, Closed']}, 'descriptionModule': {'briefSummary': 'Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo 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, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture', 'detailedDescription': "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. Previous studies in trauma patients have demonstrated patients' beliefs and expectations regarding their recovery following surgery are associated with functional limitations, lower rates of return to work, and reduced quality of life one year after injury. Furthermore, up to two thirds of patients with operative managed extremity fractures demonstrate unhelpful illness beliefs that increase risks of negative outcomes, including persistent pain. Psychological interventions, such as cognitive behavioural therapy (CBT), that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients.\n\nOur primary objective is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with an open fracture of the appendicular skeleton, or closed fracture of the lower extremity or pelvis. Our secondary objectives are to determine if CBT, versus usual care: 1) increases physical functioning, 2) improves mental functioning, 3) accelerates return to function, 4) reduces pain severity, and 5) reduces pain interference over 12 months post-fracture, and 6) reduces the proportion of participants prescribed opioid class medications (and average dose) at 6 and 12 months post-fracture in patients with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis. This trial is a multi-centre RCT of 1,000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult men or women aged 18 years and older.\n* Presenting to fracture clinic within 2-12 weeks following an acute open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis. Patients with multiple fractures may be included.\n* Fracture treated operatively with internal fixation.\n* Willing to participate in CBT\n* Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel).\n* Consistent online access from a smartphone/internet-enabled device with a minimum operating system able to use the CBT provider application or videoconferencing software applications.\n* Provision of informed consent.\n\nExclusion Criteria:\n\n* Fragility fracture.\n* Stress fracture.\n* Fracture of the hand.\n* Fracture of the foot.\n* 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.\n* Active psychosis.\n* Active suicidality.\n* 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 trial.\n* Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months).\n* Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up.\n* Incarceration.\n* Currently enrolled in a study that does not permit co-enrolment in other trials.\n* Previously enrolled in the COPE trial.\n* Other reason to exclude the patient, as approved by the Methods Centre."}, 'identificationModule': {'nctId': 'NCT03673358', 'acronym': 'COPE Pilot', 'briefTitle': 'Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Cognitive Behavioural Therapy to Optimize Post-Operative Recovery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'COPE-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - CBT', 'description': 'Participants in this arm will receive cognitive behavioural therapy. Participants will have the choice of completing six real-time telephone or video-delivered CBT sessions with a therapist OR complete online modules with asynchronous feedback with a dedicated therapist in addition to standard of care for their fracture injury.', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention- - control', 'description': '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.'}], 'interventions': [{'name': 'Cognitive Behavioural Therapy', 'type': 'BEHAVIORAL', 'description': "Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention 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 to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.\n\nOther Name: CBT", 'armGroupLabels': ['Intervention - CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'The Moncton Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Civic Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Thunder Bay Regional Health Sciences Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}], 'overallOfficials': [{'name': 'Sheila Sprague, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Jason Busse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sheila Sprague', 'investigatorAffiliation': 'McMaster University'}}}}