Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001184965
Ethics application status
Approved
Date submitted
14/11/2011
Date registered
15/11/2011
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Date results information initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness, cognitive processes and coping in chronic illness: insights from a study of joint replacement surgery
Scientific title
Mindfulness, cognitive processes and coping in chronic illness: a randomised controlled trial to evaluate the effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function
Secondary ID [1] 273380 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 279154 0
Psychological distress 279155 0
Chronic Pain 279156 0
Condition category
Condition code
Musculoskeletal 279344 279344 0 0
Osteoarthritis
Mental Health 279345 279345 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in a group program called “Mindfulness training” (MT) prior to undergoing total hip or knee replacement. Participants will be required to attend 8 weekly group sessions where they will share their experience with peers and learn a number of mindfulness skills to manage stress. They will also be expected to complete homework exercises 6 days a week in between sessions. Prior to entry to the program one interview will be held with the psychiatrist and one with the psychologist who will be facilitating the program. This will allow an introduction to the program and an informed decision about whether the program is suitable for them or not.
The group sessions will run once a week for 8 weeks. All sessions will be facilitated by both a qualified, trained mindfulness facilitator and will be of 2.5 hours duration. There will be an additional all day session on the Saturday of the 6th week and you will be invited back for a “booster” day-long work shop 3 months post-surgery. The session will provide you with education regarding the psychological impact of chronic pain and stress and will teach you a number of different mindfulness skills. At the completion of each session participants will be given mindfulness exercises to practise during the week. All sessions will take place in a group room at the study institution.

Total knee replacement is a single surgical procedure whereby the diseased knee joint is replaced with artificial one. The knee is a hinge joint which provides motion at the point where the thigh meets the lower leg. During a total knee replacement, the end of the thigh (femur) bone is removed and replaced with a metal shell. The end of the lower leg bone (tibia) is also removed and replaced with a channelled plastic piece with a metal stem. Depending on the condition of the kneecap portion of the knee joint, a plastic "button" may also be added under the kneecap surface. The procedure is performed under either a general or spinal anaesthetic and takes about 1 hour

Total hip replacement is a single surgical procedure whereby the diseased hip joint is replaced with an artificial one. The hip joint is composed of a ball and socket, with the surface of each covered by cartilage. A number of conditions and diseases can cause the cartilage surfaces to degenerate, which in turn leads to pain, stiffness, and disability. Both the ball (femoral head) and socket (acetabulum) are replaced during total hip replacement surgery. Different materials can be used in total hip replacement. Commonly, the femoral head is replaced with a metal ball and stem and a metal cup is secured into the acetabulum with a polyethylene socket. The procedure is performed under either a general or spinal anaesthetic and takes about 1 hour
Intervention code [1] 283711 0
Behaviour
Intervention code [2] 283719 0
Treatment: Surgery
Comparator / control treatment
The control group will undergo total hip or knee replacement alone
Control group
Active

Outcomes
Primary outcome [1] 279942 0
Will be self-reported pain and physical function measured on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. The WOMAC consists of 24 items covering three subscales: pain (five items), stiffness (two items) and physical function (17 items). The pain and physical function subscales will be used, each subscale transformed to a score ranging from 0 to 100, with a higher score indicating greater pain and physical function.
Timepoint [1] 279942 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [1] 294820 0
Psychological well being: will be derived from the 12-item Short Form Health Survey mental component score
Timepoint [1] 294820 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [2] 294821 0
Quality of Life: will be measured using the WHOQOL-BREF, a 26-item Quality of life Assessment
Timepoint [2] 294821 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [3] 294834 0
Depression and Anxiety: data will be derived from the Hospital Anxiety and Depression Scale (HADS), a validated instrument for detecting states of depression and anxiety and severity of emotional disorder in patients under treatment in hospital medical, surgical and outpatient departments and the Montgomery-Asberg Depression Rating Scale (MADRS), a validated and sensitive measure of treatment effect
Timepoint [3] 294834 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [4] 294835 0
Self Efficacy: will be measured using the Arthritis Self-Efficacy Scale, a 20-item questionnaire
Timepoint [4] 294835 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [5] 294836 0
Mindfulness: the Mindful Awareness Attention Scale (MAAS) is a 15 item measure assessing mindfulness and its role in psychological well-being
Timepoint [5] 294836 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [6] 294837 0
Carver Brief COPE Questionnaire: a 28-item questionnaire to measure coping styles
Timepoint [6] 294837 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [7] 294838 0
Irrational Scale: a 20-item measure of cognitive distortions
Timepoint [7] 294838 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [8] 294839 0
Brief Illness Perceptions Questionnaire: a 9-item measure of illness perceptions
Timepoint [8] 294839 0
Pre-surgery, and 3 and 12 months post surgery
Secondary outcome [9] 294840 0
Cost effectiveness of MT program plus total joint replacement compared to total joint replacement alone

Information regarding utilisation of health services, including medications and in- and outpatient services, will be captured by linkage of our database to administrative and clinical databases maintained by the study institution.
Timepoint [9] 294840 0
At 12 months post surgery

Eligibility
Key inclusion criteria
On the surgical waiting list for primary total joint replacement for end stage osteoarthritis at the study institution
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Revision surgery or surgery for neoplastic disease; (ii) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia) (mild cognitive impairment (MCI) would not be cause for exclusion); (iii) active drug or alcohol use disorder which in the opinion of the investigators makes the patient unsuitable for participation in the trial (iv) limited English language fluency (v) evidence at interview or on the Memory Complaints Questionnaire (MCQ) of presumptive cognitive impairment requiring clinical assessment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When a subject has fulfilled all study criteria allocation take place. The patient’s assignment will be performed by the data manager who will have no direct contact with the subject either before or after assignment. The clinicians involved in the assessment or treatment of patients will have no role in the assignment process. Opaque envelopes containing patient assignment will be prepared.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random assignment will be computer generated by a researcher not directly involved in the study. Randomisation will be clustered into groups of random size of between 8 and 12 to ensure even distribution without bias
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
3/09/2012
Date of last participant enrolment
Anticipated
Actual
2/10/2014
Date of last data collection
Anticipated
Actual
8/08/2016
Sample size
Target
150
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1641 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 284193 0
Government body
Name [1] 284193 0
Australian Research Council
Country [1] 284193 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Choong
Address
Department of Orthopaedics
St. Vincent's Hospital (Melbourne)
Level 3 Daly wing
35 Victoria parade
Fitzroy 3065
Victoria
Country
Australia
Secondary sponsor category [1] 269150 0
Individual
Name [1] 269150 0
Professor David Castle
Address [1] 269150 0
Mental Health Services
St. Vincent's Hospital (Melbourne)
Level 2, 46 Nicholson Street
Fitzroy 3065
Victoria
Country [1] 269150 0
Australia
Secondary sponsor category [2] 269151 0
Individual
Name [2] 269151 0
Associate Professor Michael Salzberg
Address [2] 269151 0
Mental Health Services
St. Vincent's Hospital (Melbourne)
Level 2, 46 Nicholson Street
Fitzroy 3065
Victoria
Country [2] 269151 0
Australia
Secondary sponsor category [3] 269152 0
Individual
Name [3] 269152 0
Dr Michelle Dowsey
Address [3] 269152 0
Department of Orthopaedics
St. Vincent's Hospital (Melbourne)
Level 3 Daly wing
35 Victoria parade
Fitzroy 3065
Victoria
Country [3] 269152 0
Australia
Secondary sponsor category [4] 269153 0
Individual
Name [4] 269153 0
Dr Kaveh Monshat
Address [4] 269153 0
Mental Health Services
St. Vincent's Hospital (Melbourne)
Level 2, 46 Nicholson Street
Fitzroy 3065
Victoria
Country [4] 269153 0
Australia
Secondary sponsor category [5] 269154 0
Individual
Name [5] 269154 0
Dr Simon Knowles
Address [5] 269154 0
Faculity of Life and Social Sciences
Swinburne University of Technology
PO Box 218
Hawthorn 3122
Victoria
Country [5] 269154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286160 0
The St. vincent's Hospital (Melbourne) Human Reseach Ethics Committee - A
Ethics committee address [1] 286160 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 286160 0
Australia
Date submitted for ethics approval [1] 286160 0
07/12/2011
Approval date [1] 286160 0
05/01/2012
Ethics approval number [1] 286160 0
HREC-A 143/11

Summary
Brief summary
The objectives of this research project are to: (1) identify levels of distress in patients on a waiting list for total joint arthroplasty (TJA), and (2) to determine whether administering an eight-session group mindfulness training intervention prior to surgery will improve the physical recovery of patients undergoing TJA. It is hypothesized that (1) levels of pain will be adversely associated with depression, anxiety and lower Quality of Life; (2) the intervention will lead to better tolerance of symptoms, and improved quality of life. Mindfulness is “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment”. Training involves instruction in a number of meditation techniques as well as teaching on how to remain focused on the present moment in day to day activities. There is now extensive scientific evidence showing that mindfulness training leads to an improvement in emotional and physical symptoms in a variety of disorders such as chronic pain, cancer, depression, anxiety and substance use among others. We propose to undertake a 3 year randomised controlled trial in patients with end stage osteoarthritis on the waiting list for TJA. The study will recruit 150 patients and randomly allocate them to receive the current standard of care for TJA or a combination of Mindfulness training (MT) followed by TJA. We plan to measure pain, function, quality of life, coping and mental health via validated questionnaires, as well as the cost effectiveness of a strategy that combines MT and TJA, compared to TJA alone. These measures will be taken prior to surgery and at 3 and 12 months post TJA surgery. Participants will all be followed for one year at which time the benefits in terms of health improvements after TJA will be, compared.
Trial website
Trial related presentations / publications
Knowles, S.R., Nelson, E.A., Castle, D.J., Salzberg, M.R., Choong, P.F.M. & Dowsey, M.M. (2016). Using the common sense model of illness to examine interrelationships between symptom severity and health outcomes in end-stage osteoarthritis patients. Rheumatology, 55, 1066-1073.
Public notes
This trial is now closed

Contacts
Principal investigator
Name 33383 0
Prof Peter Choong
Address 33383 0
Department of Orthopaedics, St Vincent?s
Hospital (Melbourne), PO Box 2900, Fitzroy, Melbourne, Vic. 3065, Australia
Country 33383 0
Australia
Phone 33383 0
+61 3 9231 3980
Fax 33383 0
+61 3 9416 3610
Email 33383 0
[email protected]
Contact person for public queries
Name 16630 0
Dr Michelle Dowsey
Address 16630 0
St. Vincent's Hospital (Melbourne)
Department of Orthopaedics
Level 3 Daly wing
35 Victoria parade
Fitzroy 3065
Victoria
Country 16630 0
Australia
Phone 16630 0
+61 3 9231 3955
Fax 16630 0
+61 3 9416 3610
Email 16630 0
[email protected]
Contact person for scientific queries
Name 7558 0
Dr Elizabeth Nelson
Address 7558 0
St. Vincent's Hospital (Melbourne)
Department of Orthopaedics
Level 3 Daly wing
35 Victoria parade
Fitzroy 3065
Victoria
Country 7558 0
Australia
Phone 7558 0
+61 3 9231 3516
Fax 7558 0
+61 3 9416 3610
Email 7558 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Reasonable requests for patient level data should be made to the corresponding author
and will be considered by the trial Chief Investigators. Consent for data sharing was not obtained and ethics approval would be required from the study institution for future use of patient level data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5786Study protocol    347705-(Uploaded-11-11-2019-09-25-58)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Dowsey, M., Castle D., Knowles, S., Monshat, K., S... [More Details]
Plain language summaryNo The main purpose of this study was to determine if... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial.2019https://dx.doi.org/10.1016/j.ctim.2019.08.010
N.B. These documents automatically identified may not have been verified by the study sponsor.