IMProving Outcomes With ACT After Knee Surgery
NCT Number: NCT06483191
Acronym: IMPACTS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Total Knee Arthroplasty|Knee Osteoarthritis
Interventions: BEHAVIORAL: Acceptance and Commitment Therapy
Sponsor: Belfast Health and Social Care Trust
Collaborators: Queen's University, Belfast|Trauma and Orthopaedics Research Charity
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Musgrave Park Hospital, Belfast, United Kingdom

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.

Primary Outcome Measures: 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., 6-8 weeks
Secondary Outcome Measures: 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)., 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., 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)., 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., 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., 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., 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., Pre-operation, 3 months|Length of hospital stay, Total length of hospital stay will be calculated using date of discharge and date of operation., 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., 3 months