Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483191
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-31
Brief Title:
IMProving Outcomes With ACT After Knee Surgery
Sponsor:
Belfast Health and Social Care Trust
Organization:
Belfast Health and Social Care Trust
Study Overview
Official Title:
Acceptability and Feasibility of Acceptance and Commitment Therapy in Total Knee Arthroplasty Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACTS
Brief Summary:
Regarding psychosocial factors and outcomes in total knee arthroplasty TKA most of the current literature and the investigators previous work suggest that depression anxiety and pre-operative pain strongly predict worse outcomes following TKA Despite some conflicting evidence on the whole the current literature suggests that psychological intervention in TKA patients could help to improve outcomes In recent years Acceptance and Commitment Therapy ACT has been receiving more attention as it may be more effective than the more traditional cognitive behavioural therapy in treating older people with chronic pain ACT includes a combination of acceptance and mindfulness methods along with activation and behaviour change methods
There have been several studies examining ACT in patients undergoing orthopaedic surgery These studies have found that attending a pre-operative ACT workshop and receiving text messages reinforcing ACT can reduce use of pain medication reduce post-operative pain and improve function following surgery There are also two study protocols published which plan to investigate ACT in TKA patients but the findings of these studies are yet to be reported
In this feasibility study the investigators propose to investigate the acceptability and feasibility of a pre-operative ACT workshop in TKA patients considered to be at risk of poorer outcome based on a depression score If found to be acceptable and feasible to both patients and those who will deliver the ACT sessions a larger study will be performed
There have been several studies examining ACT in patients undergoing orthopaedic surgery These studies have found that attending a pre-operative ACT workshop and receiving text messages reinforcing ACT can reduce use of pain medication reduce post-operative pain and improve function following surgery There are also two study protocols published which plan to investigate ACT in TKA patients but the findings of these studies are yet to be reported
In this feasibility study the investigators propose to investigate the acceptability and feasibility of a pre-operative ACT workshop in TKA patients considered to be at risk of poorer outcome based on a depression score If found to be acceptable and feasible to both patients and those who will deliver the ACT sessions a larger study will be performed
Detailed Description:
Regarding psychosocial factors and outcomes in total knee arthroplasty TKA most of the current literature suggests that depression anxiety and pre-operative pain strongly predict worse outcomes following TKA The investigators previous work agreed with these findings and other psychological factors such as neuroticism pain catastrophising and self-blame were associated with worse outcomes up to 1 year following TKA whilst conscientiousness pain self-efficacy and extraversion were associated with better outcomes up to 1 year following TKA These psychological factors have been less consistently associated with outcomes following joint arthroplasty in other papers and several papers have found no evidence or conflicting evidence that depression or anxiety are associated with outcomes following TKA Despite some conflicting evidence on the whole the current literature suggests that psychological intervention in TKA patients could help to improve outcomes
To date few studies have randomised patients to a psychological intervention or control group to determine whether intervention could improve outcomes following TKA or total hip arthroplasty THA A systematic review by Bay et al 2018 reported that the current literature which is still in its infancy does not support routine psychological interventions for TKA or THA This review included seven studies of randomised controlled trials RCTs of psychological interventions which involved active patient participation measured with patient reported outcomes in THA or TKA patients Only two of these studies found psychological interventions to be effective in improving at least one patient reported outcome One study used a combination of cognitive behaviour therapy and relaxation therapy in THA patients and this was found to significantly improve hip function at 1-year follow-up In the second study guided imagery improved gait velocity 6 months after TKA and reduced knee pain 3 weeks after surgery compared to the control group
Recently ACT has been receiving more attention as it may be more effective than the more traditional cognitive behavioural therapy in treating older people with chronic pain ACT includes a combination of acceptance and mindfulness methods along with activation and behaviour change methods The goal of ACT is to enhance psychological and behavioural flexibility by cultivating the six inter-rated skills of acceptance cognitive defusion present-moment awareness values clarification committed action and perspective taking
In the current literature there have been several studies examining ACT in patients undergoing orthopaedic surgery One study included 88 veterans who were undergoing orthopaedic surgery including TKA THA shoulder and spine Half of the patients were randomised to standard care and the other half attended a 1-day ACT workshop pre-operatively in addition to standard care Pain levels and opioid use were assessed up to 3 months following surgery The intervention group achieved pain and opioid cessation sooner than those in the control group Increases in pain acceptance and values-based behaviour processes targeted in ACT were related to better outcomes The other study included 76 patients who underwent operative fixation of a traumatic upper or lower extremity fracture Patients were randomised to the intervention group who received twice-daily text messages communicating an ACT-based intervention for the first 2 weeks after surgery or the control group who received no text messages At baseline patients completed paper forms comprising a basic demographics questionnaire and baseline patient-reported outcomes Two weeks following surgery patients again completed the patient reported outcomes and had an opioid medication pill count On average the intervention group used 365 fewer opioid tablets compared to the control group intervention group average 261 SD 214 tablets control group average 411 SD 220 tablets The intervention group also reported significantly lower post-operative pain compared to the control group The same group of authors then investigated ACT using the same intervention text messages sent twice a day for 2 weeks to a total of 45 THA and TKA patients who had their surgeries delayed due to the Covid-19 pandemic They found that the ACT group showed improved function and slowed decline compared to the other 45 in the control group who did not receive any text messages
There are also two study protocols published which plan to investigate ACT in TKA patients but the findings of these studies are yet to be reported
Based on the investigators previous work psychological factors are associated with TKA outcomes therefore in this feasibility study the investigators propose to examine the acceptability and feasibility of a pre-operative ACT workshop in TKA patients considered to be at risk of poorer outcomes based on a depression score If found to be acceptable and feasible to both patients and those who will deliver the ACT sessions a larger study will be performed to determine whether ACT can improve outcomes in TKA patients
The aim of this feasibility study is to determine the acceptability and feasibility of a half day pre-operative ACT workshop ACT text messages and follow-up with a physiotherapist in a cohort of patients undergoing TKA who have been identified as having a higher likelihood of a below average post-operative outcome
To date few studies have randomised patients to a psychological intervention or control group to determine whether intervention could improve outcomes following TKA or total hip arthroplasty THA A systematic review by Bay et al 2018 reported that the current literature which is still in its infancy does not support routine psychological interventions for TKA or THA This review included seven studies of randomised controlled trials RCTs of psychological interventions which involved active patient participation measured with patient reported outcomes in THA or TKA patients Only two of these studies found psychological interventions to be effective in improving at least one patient reported outcome One study used a combination of cognitive behaviour therapy and relaxation therapy in THA patients and this was found to significantly improve hip function at 1-year follow-up In the second study guided imagery improved gait velocity 6 months after TKA and reduced knee pain 3 weeks after surgery compared to the control group
Recently ACT has been receiving more attention as it may be more effective than the more traditional cognitive behavioural therapy in treating older people with chronic pain ACT includes a combination of acceptance and mindfulness methods along with activation and behaviour change methods The goal of ACT is to enhance psychological and behavioural flexibility by cultivating the six inter-rated skills of acceptance cognitive defusion present-moment awareness values clarification committed action and perspective taking
In the current literature there have been several studies examining ACT in patients undergoing orthopaedic surgery One study included 88 veterans who were undergoing orthopaedic surgery including TKA THA shoulder and spine Half of the patients were randomised to standard care and the other half attended a 1-day ACT workshop pre-operatively in addition to standard care Pain levels and opioid use were assessed up to 3 months following surgery The intervention group achieved pain and opioid cessation sooner than those in the control group Increases in pain acceptance and values-based behaviour processes targeted in ACT were related to better outcomes The other study included 76 patients who underwent operative fixation of a traumatic upper or lower extremity fracture Patients were randomised to the intervention group who received twice-daily text messages communicating an ACT-based intervention for the first 2 weeks after surgery or the control group who received no text messages At baseline patients completed paper forms comprising a basic demographics questionnaire and baseline patient-reported outcomes Two weeks following surgery patients again completed the patient reported outcomes and had an opioid medication pill count On average the intervention group used 365 fewer opioid tablets compared to the control group intervention group average 261 SD 214 tablets control group average 411 SD 220 tablets The intervention group also reported significantly lower post-operative pain compared to the control group The same group of authors then investigated ACT using the same intervention text messages sent twice a day for 2 weeks to a total of 45 THA and TKA patients who had their surgeries delayed due to the Covid-19 pandemic They found that the ACT group showed improved function and slowed decline compared to the other 45 in the control group who did not receive any text messages
There are also two study protocols published which plan to investigate ACT in TKA patients but the findings of these studies are yet to be reported
Based on the investigators previous work psychological factors are associated with TKA outcomes therefore in this feasibility study the investigators propose to examine the acceptability and feasibility of a pre-operative ACT workshop in TKA patients considered to be at risk of poorer outcomes based on a depression score If found to be acceptable and feasible to both patients and those who will deliver the ACT sessions a larger study will be performed to determine whether ACT can improve outcomes in TKA patients
The aim of this feasibility study is to determine the acceptability and feasibility of a half day pre-operative ACT workshop ACT text messages and follow-up with a physiotherapist in a cohort of patients undergoing TKA who have been identified as having a higher likelihood of a below average post-operative outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None