IMProving Outcomes With ACT After Knee Surgery

NCT06483191 | Not Yet Recruiting

• 1 other identifier: 23007RN-SW
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Knee Osteoarthritis

Outcome Measures

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.

  6-8 weeks

Secondary Outcomes (9)

• Change in Oxford Knee Score (OKS) from pre-operation to 3 months

  Preoperation, 3 months

• EuroQol-5D-5L

  Pre-operation, 3 months

• EuroQoL-5D Visual Analogue Scale (VAS)

  Pre-operation, 3 months

• Pain Interference

  Pre-operation, 3 months

• Acceptance and Action Questionnaire (AAQ)

  Pre-operation, 3 months

Study Arms (2)

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.

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.

Interventions

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).

Also known as: ACT

Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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".

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Queen's University, Belfast: collaborator
• Trauma and Orthopaedics Research Charity: collaborator

Study Sites (1)

Musgrave Park Hospital

Belfast, United Kingdom

Location

Related Publications (24)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Richard Napier

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Gallagher

CONTACT

02895043746; nicola.gallagher@belfasttrust.hscni.net

Janet Hill

CONTACT

02895046799; janet.hill@belfasttrust.hscni.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Chief Investigator will be blinded to what group patients are randomised to. It will not be possible to blind the patients, research team or physiotherapists involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centred, parallel group, randomised controlled trial

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: July 3, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)