Total Knee ArthroplastyIMPACTSNCT06483191
IMProving Outcomes With ACT After Knee Surgery
A study testing Acceptance and Commitment Therapy in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Knee Arthroplasty, Knee Osteoarthritis
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old scheduled for routine primary elective TKA.
- Participants must have a functional level of spoken and written English and be able to complete the online pre-operative psychosocial questionnaire independently.
- Patients must have scored 10 or more on the Depression subscale of the (Depression, Anxiety and Stress Scale) DASS-21 of the pre-operative psychosocial questionnaire.
Who cannot join
- Any patient who does not have access to a mobile phone to receive the booster text messages, or online facilities to answer online questionnaires.
- Any patient who has a significant change (≥3 months) in scheduled date of surgery i.e. has a delayed surgery or surgery earlier than expected.
- Any patient who does not attend the pre-operative education class.
- Any patient scheduled for revision, uni-compartmental or bilateral TKA.
- Any patient who has further orthopaedic surgery planned in the next 3 months.
- Any patient who cannot commit to the schedule of events.
- Any patient currently receiving any other "talking therapy".
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acceptability and Feasibility of Acceptance and Commitment Therapy in Total Knee Arthroplasty Patients
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.
Read the 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 36.5% fewer opioid tablets compared to the control group (intervention group average: 26.1 (SD 21.4) tablets, control group average: 41.1 (SD 22.0) 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.
- Conditions
- Total Knee Arthroplasty, Knee Osteoarthritis
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
A half-day pre-operative virtual ACT group workshop, booster post-operative ACT text messages once a week for 6 weeks and a telephone follow-up with a physiotherapist at 6-8 weeks (all in addition to standard care).
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Patients will attend a half-day virtual pre-operative ACT group workshop delivered by physiotherapists. Intervention group patients will also receive booster post-operative ACT text messages once a week for 6 weeks and a telephone follow-up with a physiotherapist at 6-8 weeks. The workshop, text messages and follow-up with a physiotherapist will be in addition to standard care. Receives: Behavioral: Acceptance and Commitment Therapy |
| Control | No intervention | Patients in the control group will receive standard care; All patients should attend a 1-hour face-to-face group pre-operative education class. Patients in either group will have access to a helpline where they can speak to a nurse to discuss any problems or concerns. All patients will also receive a follow-up phone call from a nurse within 5 days of discharge to check their progress and will attend a 6-12 week follow-up clinic with their surgeon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility of the intervention
Acceptability of the intervention will be assessed via an online questionnaire to be completed by patients who were randomised to the intervention group. Patients in the control group will also complete a modified set of questions to determine how they felt being randomised to the standard care group and whether they would have liked more support.
Measured: 6-8 weeks
Secondary outcomes (9)
Change in Oxford Knee Score (OKS) from pre-operation to 3 months
The OKS will be completed by participants online, with a score ranging from 0 (worst score possible) - 48 (best score possible).
Measured: Preoperation, 3 months
EuroQol-5D-5L
The EQ-5D-5L will be completed by participants online. A single score will be derived which ranges from -0.594 to 1, where 0 is death and 1 is full health.
Measured: Pre-operation, 3 months
EuroQoL-5D Visual Analogue Scale (VAS)
The EQ-5D VAS will also be scored from 0 (worst health possible) - 100 (best health possible).
Measured: Pre-operation, 3 months
Pain Interference
Pain interference will be completed by all patients recruited to the study (following consent and prior to randomisation before attending the pre-operative ACT workshop for the intervention group) and at 3 months post-operatively.
Measured: Pre-operation, 3 months
Acceptance and Action Questionnaire (AAQ)
The Acceptance and Action Questionnaire (AAQ) will be completed by all patients recruited to the study (following consent and prior to randomisation before attending the pre-operative ACT workshop for the intervention group) and at 3 months post-operatively.
Measured: Pre-operation, 3 months
Chronic Pain Acceptance Questionnaire-2 (CPAQ-2)
The Chronic Pain Acceptance Questionnaire-2 (CPAQ-2) will be completed by all patients recruited to the study (following consent and prior to randomisation before attending the pre-operative ACT workshop for the intervention group) and at 3 months post-operatively.
Measured: Pre-operation, 3 months
Chronic Pain Values Inventory (CPVI)
The Chronic Pain Values Inventory (CPVI) will be completed by all patients recruited to the study (following consent and prior to randomisation before attending the pre-operative ACT workshop for the intervention group) and at 3 months post-operatively.
Measured: Pre-operation, 3 months
Length of hospital stay
Total length of hospital stay will be calculated using date of discharge and date of operation.
Measured: 3 months
Post-discharge Non-Scheduled Contact
This will include inpatient or outpatient physiotherapy sessions, unscheduled face-to-face contact with nurse, orthopaedic surgeon or physiotherapist, phone calls to physiotherapist team, helpline calls, out of hours attendances, A\&E attendances, hospital readmissions and returns to theatre up to 90 days post-operation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Model description
- A single centred, parallel group, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, Trauma and Orthopaedics Research Charity
- Responsible party
- Sponsor
- Investigators
- Richard Napier, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483191
- Sponsor's protocol ID
- 23007RN-SW
- Acronym
- IMPACTS
- Status last verified
- May 2025
- First submitted
- 31 Jan 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorel JC, Veltman ES, Honig A, Poolman RW. The influence of preoperative psychological distress on pain and function after total knee arthroplasty: a systematic review and meta-analysis. Bone Joint J. 2019 Jan;101-B(1):7-14. doi: 10.1302/0301-620X.101B1.BJJ-2018-0672.R1.
PubMed 30601044Hernandez C, Diaz-Heredia J, Berraquero ML, Crespo P, Loza E, Ruiz Iban MA. Pre-operative Predictive Factors of Post-operative Pain in Patients With Hip or Knee Arthroplasty: A Systematic Review. Reumatol Clin. 2015 Nov-Dec;11(6):361-80. doi: 10.1016/j.reuma.2014.12.008. Epub 2015 Apr 1. English, Spanish.
PubMed 25840826Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
PubMed 25542191Alattas SA, Smith T, Bhatti M, Wilson-Nunn D, Donell S. Greater pre-operative anxiety, pain and poorer function predict a worse outcome of a total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3403-3410. doi: 10.1007/s00167-016-4314-8. Epub 2016 Oct 12.
PubMed 27734110Lungu E, Vendittoli PA, Desmeules F. Preoperative Determinants of Patient-reported Pain and Physical Function Levels Following Total Knee Arthroplasty: A Systematic Review. Open Orthop J. 2016 Jun 23;10:213-31. doi: 10.2174/1874325001610010213. eCollection 2016.
PubMed 27398109Hofstede SN, Gademan MG, Vliet Vlieland TP, Nelissen RG, Marang-van de Mheen PJ. Preoperative predictors for outcomes after total hip replacement in patients with osteoarthritis: a systematic review. BMC Musculoskelet Disord. 2016 May 17;17:212. doi: 10.1186/s12891-016-1070-3.
PubMed 27184266Lindner M, Nosseir O, Keller-Pliessnig A, Teigelack P, Teufel M, Tagay S. Psychosocial predictors for outcome after total joint arthroplasty: a prospective comparison of hip and knee arthroplasty. BMC Musculoskelet Disord. 2018 May 22;19(1):159. doi: 10.1186/s12891-018-2058-y.
PubMed 29788969Belford K, Gallagher N, Dempster M, Wolfenden M, Hill J, Blaney J, O'Brien S, Smit AM, Botha P, Molloy D, Beverland D. Psychosocial predictors of outcomes up to one year following total knee arthroplasty. Knee. 2020 Jun;27(3):1028-1034. doi: 10.1016/j.knee.2020.03.006. Epub 2020 Apr 13.
PubMed 32299757Vissers MM, Bussmann JB, Verhaar JA, Busschbach JJ, Bierma-Zeinstra SM, Reijman M. Psychological factors affecting the outcome of total hip and knee arthroplasty: a systematic review. Semin Arthritis Rheum. 2012 Feb;41(4):576-88. doi: 10.1016/j.semarthrit.2011.07.003. Epub 2011 Oct 28.
PubMed 22035624Magklara E, Burton CR, Morrison V. Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review. Clin Rehabil. 2014 Sep;28(9):835-46. doi: 10.1177/0269215514527843. Epub 2014 Mar 25.
PubMed 24668361Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.
PubMed 25609995Riddle DL, Wade JB, Jiranek WA, Kong X. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. Clin Orthop Relat Res. 2010 Mar;468(3):798-806. doi: 10.1007/s11999-009-0963-y. Epub 2009 Jul 8.
PubMed 19585177Riddle DL, Jensen MP, Ang D, Slover J, Perera R, Dumenci L. Do Pain Coping and Pain Beliefs Associate With Outcome Measures Before Knee Arthroplasty in Patients Who Catastrophize About Pain? A Cross-sectional Analysis From a Randomized Clinical Trial. Clin Orthop Relat Res. 2018 Apr;476(4):778-786. doi: 10.1007/s11999.0000000000000001.
PubMed 29543659Bletterman AN, de Geest-Vrolijk ME, Vriezekolk JE, Nijhuis-van der Sanden MW, van Meeteren NL, Hoogeboom TJ. Preoperative psychosocial factors predicting patient's functional recovery after total knee or total hip arthroplasty: a systematic review. Clin Rehabil. 2018 Apr;32(4):512-525. doi: 10.1177/0269215517730669. Epub 2017 Sep 19.
PubMed 28922942Khatib Y, Madan A, Naylor JM, Harris IA. Do Psychological Factors Predict Poor Outcome in Patients Undergoing TKA? A Systematic Review. Clin Orthop Relat Res. 2015 Aug;473(8):2630-8. doi: 10.1007/s11999-015-4234-9. Epub 2015 Mar 20.
PubMed 25791440
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Acceptance and Commitment Therapy in Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT06483191
- Acronym / sponsor ID
- IMPACTS / 23007RN-SW
- Conditions
- Total Knee Arthroplasty, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, Trauma and Orthopaedics Research Charity
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
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.
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 36.5% fewer opioid tablets compared to the control group (intervention group average: 26.1 (SD 21.4) tablets, control group average: 41.1 (SD 22.0) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A single centred, parallel group, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment TherapyPatients will attend a half-day virtual pre-operative ACT group workshop delivered by physiotherapists. Intervention group patients will also receive booster post-operative ACT text messages once a week for 6 weeks and a telephone follow-up with a physiotherapist at 6-8 weeks. The workshop, text messages and follow-up with a physiotherapist will be in addition to standard care. |
| Control | No intervention | –Patients in the control group will receive standard care; All patients should attend a 1-hour face-to-face group pre-operative education class. Patients in either group will have access to a helpline where they can speak to a nurse to discuss any problems or concerns. All patients will also receive a follow-up phone call from a nurse within 5 days of discharge to check their progress and will attend a 6-12 week follow-up clinic with their surgeon. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old scheduled for routine primary elective TKA.
- Participants must have a functional level of spoken and written English and be able to complete the online pre-operative psychosocial questionnaire independently.
- Patients must have scored 10 or more on the Depression subscale of the (Depression, Anxiety and Stress Scale) DASS-21 of the pre-operative psychosocial questionnaire.
Key exclusion criteria (7 listed)
- Any patient who does not have access to a mobile phone to receive the booster text messages, or online facilities to answer online questionnaires.
- Any patient who has a significant change (≥3 months) in scheduled date of surgery i.e. has a delayed surgery or surgery earlier than expected.
- Any patient who does not attend the pre-operative education class.
- Any patient scheduled for revision, uni-compartmental or bilateral TKA.
- Any patient who has further orthopaedic surgery planned in the next 3 months.
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 |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTA half-day pre-operative virtual ACT group workshop, booster post-operative ACT text messages once a week for 6 weeks and a telephone follow-up with a physiotherapist at 6-8 weeks (all in addition to standard care). | Behavioural | Acceptance and Commitment Therapy (ACT) |
Primary outcome
Acceptability and feasibility of the intervention
Time frame: 6-8 weeks
Acceptability of the intervention will be assessed via an online questionnaire to be completed by patients who were randomised to the intervention group. Patients in the control group will also complete a modified set of questions to determine how they felt being randomised to the standard care group and whether they would have liked more support.
9 secondary outcomes
Change in Oxford Knee Score (OKS) from pre-operation to 3 months
Time frame: Preoperation, 3 months
EuroQol-5D-5L
Time frame: Pre-operation, 3 months
EuroQoL-5D Visual Analogue Scale (VAS)
Time frame: Pre-operation, 3 months
Pain Interference
Time frame: Pre-operation, 3 months
Acceptance and Action Questionnaire (AAQ)
Time frame: Pre-operation, 3 months
Chronic Pain Acceptance Questionnaire-2 (CPAQ-2)
Time frame: Pre-operation, 3 months
Chronic Pain Values Inventory (CPVI)
Time frame: Pre-operation, 3 months
Length of hospital stay
Time frame: 3 months
Post-discharge Non-Scheduled Contact
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 30601044Sorel JC, Veltman ES, Honig A, Poolman RW. The influence of preoperative psychological distress on pain and function after total knee arthroplasty: a systematic review and meta-analysis. Bone Joint J. 2019 Jan;101-B(1):7-14. doi: 10.1302/0301-620X.101B1.BJJ-2018-0672.R1.
- Background: PubMed 25840826Hernandez C, Diaz-Heredia J, Berraquero ML, Crespo P, Loza E, Ruiz Iban MA. Pre-operative Predictive Factors of Post-operative Pain in Patients With Hip or Knee Arthroplasty: A Systematic Review. Reumatol Clin. 2015 Nov-Dec;11(6):361-80. doi: 10.1016/j.reuma.2014.12.008. Epub 2015 Apr 1. English, Spanish.
- Background: PubMed 25542191Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
- Background: PubMed 27734110Alattas SA, Smith T, Bhatti M, Wilson-Nunn D, Donell S. Greater pre-operative anxiety, pain and poorer function predict a worse outcome of a total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3403-3410. doi: 10.1007/s00167-016-4314-8. Epub 2016 Oct 12.
- Background: PubMed 27398109Lungu E, Vendittoli PA, Desmeules F. Preoperative Determinants of Patient-reported Pain and Physical Function Levels Following Total Knee Arthroplasty: A Systematic Review. Open Orthop J. 2016 Jun 23;10:213-31. doi: 10.2174/1874325001610010213. eCollection 2016.
- Background: PubMed 27184266Hofstede SN, Gademan MG, Vliet Vlieland TP, Nelissen RG, Marang-van de Mheen PJ. Preoperative predictors for outcomes after total hip replacement in patients with osteoarthritis: a systematic review. BMC Musculoskelet Disord. 2016 May 17;17:212. doi: 10.1186/s12891-016-1070-3.
- Background: PubMed 29788969Lindner M, Nosseir O, Keller-Pliessnig A, Teigelack P, Teufel M, Tagay S. Psychosocial predictors for outcome after total joint arthroplasty: a prospective comparison of hip and knee arthroplasty. BMC Musculoskelet Disord. 2018 May 22;19(1):159. doi: 10.1186/s12891-018-2058-y.
- Background: PubMed 32299757Belford K, Gallagher N, Dempster M, Wolfenden M, Hill J, Blaney J, O'Brien S, Smit AM, Botha P, Molloy D, Beverland D. Psychosocial predictors of outcomes up to one year following total knee arthroplasty. Knee. 2020 Jun;27(3):1028-1034. doi: 10.1016/j.knee.2020.03.006. Epub 2020 Apr 13.
- Background: PubMed 22035624Vissers MM, Bussmann JB, Verhaar JA, Busschbach JJ, Bierma-Zeinstra SM, Reijman M. Psychological factors affecting the outcome of total hip and knee arthroplasty: a systematic review. Semin Arthritis Rheum. 2012 Feb;41(4):576-88. doi: 10.1016/j.semarthrit.2011.07.003. Epub 2011 Oct 28.
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- 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.
Richard Napier principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Gallagher (02895043746, nicola.gallagher@belfasttrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and feasibility of the intervention (time frame: 6-8 weeks). 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 NCT06483191, which also lists 24 linked publications.
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 13 May 2025.