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Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial

Roshan das Nair, Pippa Anderson, Simon Clarke, Paul Leighton, Nadina B. Lincoln, Jacqueline R. Mhizha-Murira, Brigitte E. Scammell, David A. Walsh

Trials, Volume: 17, Issue: 1

Swansea University Author: Pippa Anderson

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DOI (Published version): 10.1186/s13063-016-1165-z

Abstract

BackgroundKnee replacement surgery reduces pain for many people with osteoarthritis (OA). However, surgical outcomes are partly dependent on patients’ moods, and those with depression or anxiety have worse outcomes. Approximately one-third of people with OA have mood problems. Cognitive behavioural...

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Published in: Trials
ISSN: 1745-6215
Published: 2016
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URI: https://cronfa.swan.ac.uk/Record/cronfa26174
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first_indexed 2016-02-13T02:01:41Z
last_indexed 2018-11-13T13:42:45Z
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2018-11-13T10:05:58.2475720</datestamp><bib-version>v2</bib-version><id>26174</id><entry>2016-02-12</entry><title>Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial</title><swanseaauthors><author><sid>128cdedfba6e5e6374fdc85d5c78c428</sid><firstname>Pippa</firstname><surname>Anderson</surname><name>Pippa Anderson</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2016-02-12</date><deptcode>FGMHL</deptcode><abstract>BackgroundKnee replacement surgery reduces pain for many people with osteoarthritis (OA). However, surgical outcomes are partly dependent on patients&#x2019; moods, and those with depression or anxiety have worse outcomes. Approximately one-third of people with OA have mood problems. Cognitive behavioural therapy (CBT), a psychological therapy, is recommended by the National Institute for Health and Care Excellence for improving mood. However, evidence for the effectiveness of CBT before knee surgery in improving pain, mood, and quality of life following this surgery for people with knee OA is lacking.Methods/DesignThis is a multi-centre, mixed-methods feasibility randomised controlled trial to compare treatment as usual (TAU) plus a brief CBT-based intervention with a TAU-only control, for people with knee OA. We will recruit 50 patients with knee OA, listed for knee replacement surgery, with high levels of distress (assessed using a mood questionnaire), and who consent to take part. Participants will be randomly allocated to receive TAU plus intervention or TAU. Up to 10 sessions of CBT will be offered on an individual basis by a psychologist. The assessments and interventions will be completed before surgery. Repeat assessments at 4 and 6 months after randomisation will be sent and received by post.Two patient-partners will conduct feedback interviews with some participants to assess what aspects of the intervention were helpful or unhelpful, the acceptability of randomisation, the experience of being in a control group, and the appropriateness of the measures used. Interviews will be audio-recorded, transcribed, and analysed using the framework approach. We will examine the feasibility and acceptability of patient-partners conducting the interviews by also interviewing the patient-partners.DiscussionFindings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT intervention in improving patient outcomes following knee surgery.</abstract><type>Journal Article</type><journal>Trials</journal><volume>17</volume><journalNumber>1</journalNumber><publisher/><issnElectronic>1745-6215</issnElectronic><keywords>Chronic pain &#x2013; Cognitive behavioural therapy &#x2013; Knee osteoarthritis &#x2013; Depression &#x2013; Anxiety &#x2013; Quality of life</keywords><publishedDay>27</publishedDay><publishedMonth>1</publishedMonth><publishedYear>2016</publishedYear><publishedDate>2016-01-27</publishedDate><doi>10.1186/s13063-016-1165-z</doi><url>URL: http://www.trialsjournal.com/content/17/1/54</url><notes/><college>COLLEGE NANME</college><department>Medicine, Health and Life Science - Faculty</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>FGMHL</DepartmentCode><institution>Swansea University</institution><apcterm/><lastEdited>2018-11-13T10:05:58.2475720</lastEdited><Created>2016-02-12T14:21:45.7175469</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care</level></path><authors><author><firstname>Roshan</firstname><surname>das Nair</surname><order>1</order></author><author><firstname>Pippa</firstname><surname>Anderson</surname><order>2</order></author><author><firstname>Simon</firstname><surname>Clarke</surname><order>3</order></author><author><firstname>Paul</firstname><surname>Leighton</surname><order>4</order></author><author><firstname>Nadina B.</firstname><surname>Lincoln</surname><order>5</order></author><author><firstname>Jacqueline R.</firstname><surname>Mhizha-Murira</surname><order>6</order></author><author><firstname>Brigitte E.</firstname><surname>Scammell</surname><order>7</order></author><author><firstname>David A.</firstname><surname>Walsh</surname><order>8</order></author></authors><documents/><OutputDurs/></rfc1807>
spelling 2018-11-13T10:05:58.2475720 v2 26174 2016-02-12 Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial 128cdedfba6e5e6374fdc85d5c78c428 Pippa Anderson Pippa Anderson true false 2016-02-12 FGMHL BackgroundKnee replacement surgery reduces pain for many people with osteoarthritis (OA). However, surgical outcomes are partly dependent on patients’ moods, and those with depression or anxiety have worse outcomes. Approximately one-third of people with OA have mood problems. Cognitive behavioural therapy (CBT), a psychological therapy, is recommended by the National Institute for Health and Care Excellence for improving mood. However, evidence for the effectiveness of CBT before knee surgery in improving pain, mood, and quality of life following this surgery for people with knee OA is lacking.Methods/DesignThis is a multi-centre, mixed-methods feasibility randomised controlled trial to compare treatment as usual (TAU) plus a brief CBT-based intervention with a TAU-only control, for people with knee OA. We will recruit 50 patients with knee OA, listed for knee replacement surgery, with high levels of distress (assessed using a mood questionnaire), and who consent to take part. Participants will be randomly allocated to receive TAU plus intervention or TAU. Up to 10 sessions of CBT will be offered on an individual basis by a psychologist. The assessments and interventions will be completed before surgery. Repeat assessments at 4 and 6 months after randomisation will be sent and received by post.Two patient-partners will conduct feedback interviews with some participants to assess what aspects of the intervention were helpful or unhelpful, the acceptability of randomisation, the experience of being in a control group, and the appropriateness of the measures used. Interviews will be audio-recorded, transcribed, and analysed using the framework approach. We will examine the feasibility and acceptability of patient-partners conducting the interviews by also interviewing the patient-partners.DiscussionFindings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT intervention in improving patient outcomes following knee surgery. Journal Article Trials 17 1 1745-6215 Chronic pain – Cognitive behavioural therapy – Knee osteoarthritis – Depression – Anxiety – Quality of life 27 1 2016 2016-01-27 10.1186/s13063-016-1165-z URL: http://www.trialsjournal.com/content/17/1/54 COLLEGE NANME Medicine, Health and Life Science - Faculty COLLEGE CODE FGMHL Swansea University 2018-11-13T10:05:58.2475720 2016-02-12T14:21:45.7175469 Faculty of Medicine, Health and Life Sciences School of Health and Social Care Roshan das Nair 1 Pippa Anderson 2 Simon Clarke 3 Paul Leighton 4 Nadina B. Lincoln 5 Jacqueline R. Mhizha-Murira 6 Brigitte E. Scammell 7 David A. Walsh 8
title Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
spellingShingle Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
Pippa Anderson
title_short Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
title_full Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
title_fullStr Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
title_full_unstemmed Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
title_sort Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
author_id_str_mv 128cdedfba6e5e6374fdc85d5c78c428
author_id_fullname_str_mv 128cdedfba6e5e6374fdc85d5c78c428_***_Pippa Anderson
author Pippa Anderson
author2 Roshan das Nair
Pippa Anderson
Simon Clarke
Paul Leighton
Nadina B. Lincoln
Jacqueline R. Mhizha-Murira
Brigitte E. Scammell
David A. Walsh
format Journal article
container_title Trials
container_volume 17
container_issue 1
publishDate 2016
institution Swansea University
issn 1745-6215
doi_str_mv 10.1186/s13063-016-1165-z
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care
url URL: http://www.trialsjournal.com/content/17/1/54
document_store_str 0
active_str 0
description BackgroundKnee replacement surgery reduces pain for many people with osteoarthritis (OA). However, surgical outcomes are partly dependent on patients’ moods, and those with depression or anxiety have worse outcomes. Approximately one-third of people with OA have mood problems. Cognitive behavioural therapy (CBT), a psychological therapy, is recommended by the National Institute for Health and Care Excellence for improving mood. However, evidence for the effectiveness of CBT before knee surgery in improving pain, mood, and quality of life following this surgery for people with knee OA is lacking.Methods/DesignThis is a multi-centre, mixed-methods feasibility randomised controlled trial to compare treatment as usual (TAU) plus a brief CBT-based intervention with a TAU-only control, for people with knee OA. We will recruit 50 patients with knee OA, listed for knee replacement surgery, with high levels of distress (assessed using a mood questionnaire), and who consent to take part. Participants will be randomly allocated to receive TAU plus intervention or TAU. Up to 10 sessions of CBT will be offered on an individual basis by a psychologist. The assessments and interventions will be completed before surgery. Repeat assessments at 4 and 6 months after randomisation will be sent and received by post.Two patient-partners will conduct feedback interviews with some participants to assess what aspects of the intervention were helpful or unhelpful, the acceptability of randomisation, the experience of being in a control group, and the appropriateness of the measures used. Interviews will be audio-recorded, transcribed, and analysed using the framework approach. We will examine the feasibility and acceptability of patient-partners conducting the interviews by also interviewing the patient-partners.DiscussionFindings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT intervention in improving patient outcomes following knee surgery.
published_date 2016-01-27T03:31:18Z
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