IMProving Outcomes With ACT After Knee Surgery (IMPACTS)

May 8, 2025 updated by: Belfast Health and Social Care Trust

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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".

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acceptance and Commitment Therapy (ACT)
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.
Behavioral: Acceptance and Commitment Therapy
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).
Other Names:
  • ACT
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxford Knee Score (OKS) from pre-operation to 3 months
Time Frame: Preoperation, 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
Time Frame: Pre-operation, 3 months
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)
Time Frame: Pre-operation, 3 months
The EQ-5D VAS will also be scored from 0 (worst health possible) - 100 (best health possible).
Pre-operation, 3 months
Pain Interference
Time Frame: Pre-operation, 3 months
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)
Time Frame: Pre-operation, 3 months
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)
Time Frame: Pre-operation, 3 months
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)
Time Frame: Pre-operation, 3 months
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
Time Frame: 3 months
Total length of hospital stay will be calculated using date of discharge and date of operation.
3 months
Post-discharge Non-Scheduled Contact
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Collaborators

Queen's University, Belfast
Trauma and Orthopaedics Research Charity

Investigators

  • Principal Investigator: Richard Napier, Belfast Health and Social Care Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23007RN-SW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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