IMProving Outcomes With ACT After Knee Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBelfast Health and Social Care Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acceptance and Commitment Therapy

    Behavioral

    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).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Acceptance and Commitment Therapy (ACT)Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6-8 weeks

Secondary outcomes

1

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).

Time frame
Preoperation, 3 months
2

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.

Time frame
Pre-operation, 3 months
3

EuroQoL-5D Visual Analogue Scale (VAS)

The EQ-5D VAS will also be scored from 0 (worst health possible) - 100 (best health possible).

Time frame
Pre-operation, 3 months
4

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.

Time frame
Pre-operation, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Belfast Health and Social Care Trust

Lead sponsor

Queen's University, Belfast

Collaborator

Trauma and Orthopaedics Research Charity

Collaborator

This trial is not recruiting at the moment. You can still explore other options: