Pain, PostoperativeCOPE PilotNCT03673358
Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot
A study testing Cognitive Behavioural Therapy in people with Pain, Postoperative and Fractures, Open, run by McMaster University at 6 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Fractures, Open, Fractures, Closed
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 6 sitesCanada
- Study dates
- 9 Jan 2019to 8 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women aged 18 years and older.
- 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.
- Fracture treated operatively with internal fixation.
- Willing to participate in CBT
- Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel).
- 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.
- Provision of informed consent.
Who cannot join
- Fragility fracture.
- Stress fracture.
- Fracture of the hand.
- Fracture of the foot.
- 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.
- Active psychosis.
Show all 14Show fewer
- Active suicidality.
- 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.
- Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months).
- Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up.
- Incarceration.
- Currently enrolled in a study that does not permit co-enrolment in other trials.
- Previously enrolled in the COPE trial.
- Other reason to exclude the patient, as approved by the Methods Centre.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
QEII Health Sciences Centre
Halifax, Nova Scotia
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre
London, Ontario
Ottawa Civic Hospital
Ottawa, Ontario
The Moncton Hospital
Saint John, New Brunswick, E2L 4L2
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
About this study
Official title: Cognitive Behavioural Therapy to Optimize Post-Operative Recovery: A Randomized Controlled Trial
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
Read the detailed description
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.
Our 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.
- Conditions
- Pain, Postoperative, Fractures, Open, Fractures, Closed
- Being tested
- Cognitive Behavioural Therapy
- Medical subject headings
- Pain, Postoperative, Fractures, Open, Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
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.
Other Name: CBT
| Study group | Role | What they receive |
|---|---|---|
| Intervention - CBT | Experimental | 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. Receives: Behavioral: Cognitive Behavioural Therapy |
| No intervention- - control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture
The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition.
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 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.
Measured: 12 months post-fracture
Secondary outcomes (4)
Short Form 36 (SF-36)
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).
Measured: 12 months post-fracture
Return to Function questionnaire
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.
Measured: 12 months post-fracture
BPI-SF
The Brief Pain Inventory (BPI) assess pain severity and its impact on function
Measured: 12 months post-fracture
Opioid Use
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.
Measured: 12 months post-fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start9 Jan 2019
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Why it stopped: Low compliance with CBT, and challenges with the CBT provider. Previous participants will be considered the pilot phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Orthopaedic Trauma Association
- Responsible party
- Principal investigator, Sheila Sprague, McMaster University
- Investigators
- Sheila Sprague, PhD, Principal investigator, McMaster UniversityJason Busse, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673358
- Sponsor's protocol ID
- COPE-001
- Acronym
- COPE Pilot
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy to Optimize Post-Operative Recovery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03673358
- Acronym / sponsor ID
- COPE Pilot / COPE-001
- Conditions
- Pain, Postoperative, Fractures, Open, Fractures, Closed
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low compliance with CBT, and challenges with the CBT provider. Previous participants will be considered the pilot phase.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Orthopaedic Trauma Association
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 17 Sep 2018 (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.
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
Detailed description
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.
Our 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention - CBT | Experimental | Behavioral: Cognitive Behavioural TherapyParticipants 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. |
| No intervention- - control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men or women aged 18 years and older.
- 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.
- Fracture treated operatively with internal fixation.
- Willing to participate in CBT
- Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel).
Key exclusion criteria (14 listed)
- Fragility fracture.
- Stress fracture.
- Fracture of the hand.
- Fracture of the foot.
- 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.
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 |
|---|---|---|
| Cognitive Behavioural TherapyParticipants 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. Other Name: CBT | Behavioural | Intervention - CBT |
Primary outcome
The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture
Time frame: 12 months post-fracture
The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition. 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 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.
4 secondary outcomes
Short Form 36 (SF-36)
Time frame: 12 months post-fracture
Return to Function questionnaire
Time frame: 12 months post-fracture
BPI-SF
Time frame: 12 months post-fracture
Opioid Use
Time frame: 12 months post-fracture
Results and safety
The study was stopped early (reason given: Low compliance with CBT, and challenges with the CBT provider. Previous participants will be considered the pilot phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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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.
Sheila Sprague, PhD principal investigator
McMaster University
Jason Busse, PhD principal investigator
McMaster University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Pain, Postoperative and Fractures, Open, run by McMaster University at 6 sites in Canada.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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. 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 was stopped early (reason given: Low compliance with CBT, and challenges with the CBT provider. Previous participants will be considered the pilot phase.). Results are not available in the source record.
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?
The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture (time frame: 12 months post-fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2020.