Andersen, P; Araya, R; Barkham, M; Bower, P; Brabyn, S

205 Pages·2017·17.21 MB·English

HEALTH TECHNOLOGY ASSESSMENT
VOLUME 19 ISSUE 101 DECEMBER 2015
ISSN 1366-5278
A randomised controlled trial of computerised
cognitive behaviour therapy for the treatment of
depression in primary care: the Randomised
Evaluation of the Effectiveness and Acceptability
of Computerised Therapy (REEACT) trial
Elizabeth Littlewood, Ana Duarte, Catherine Hewitt, Sarah Knowles,
Stephen Palmer, Simon Walker, Phil Andersen, Ricardo Araya,
Michael Barkham, Peter Bower, Sally Brabyn, Gwen Brierley, Cindy Cooper,
Linda Gask, David Kessler, Helen Lester, Karina Lovell, Usman Muhammad,
Glenys Parry, David A Richards, Rachel Richardson, Debbie Tallon,
Puvan Tharmanathan, David White and Simon Gilbody
on behalf of the REEACT Team
DOI 10.3310/hta191010

A randomised controlled trial of computerised
cognitive behaviour therapy for the treatment
of depression in primary care: the Randomised
Evaluation of the Effectiveness and
Acceptability of Computerised Therapy
(REEACT) trial
Elizabeth Littlewood,1 Ana Duarte,2 Catherine Hewitt,3
Sarah Knowles,4,5 Stephen Palmer,2 Simon Walker,2
Phil Andersen,1 Ricardo Araya,6,7 Michael Barkham,8
Peter Bower,5 Sally Brabyn,1 Gwen Brierley,1,9
Cindy Cooper,10 Linda Gask,5 David Kessler,11
Helen Lester,5,12† Karina Lovell,13 Usman Muhammad,3
Glenys Parry,10 David A Richards,1,14 Rachel Richardson,1
Debbie Tallon,15 Puvan Tharmanathan,3 David White10
and Simon Gilbody1* on behalf of the REEACT Team
1Department of HealthSciences, University of York, York, UK
2Centre forHealth Economics, University ofYork, York, UK
3YorkTrials Unit,Department ofHealth Sciences, University ofYork, York, UK
4Centre forPrimary Care, Institute ofPopulation Health, University ofManchester,
Manchester, UK
5National Institute for HealthResearch (NIHR) School for PrimaryCare Research, Manchester
Academic Health Science Centre,University ofManchester, Manchester, UK (previously National
Primary CareResearch and Development Centre,University ofManchester, Manchester, UK)
6Academic Unit of Psychiatry, University ofBristol, Bristol, UK
7DepartmentofPopulationHealth,LondonSchoolofHygieneandTropicalMedicine,London,UK
8Centre forPsychological Services Research, University ofSheffield, Sheffield, UK
9Medical Research Council (MRC) Epidemiology Unit, University of Cambridge School ofClinical
Medicine, Cambridge, UK
10Clinical Trials Research Unit, School ofHealth and Related Research, University of Sheffield,
Sheffield, UK
11Academic Unit ofPrimary Health Care, University of Bristol, Bristol, UK
12Primary CareClinical Sciences, University ofBirmingham, Birmingham, UK
13School ofNursing, Midwifery and Social Work, University of Manchester, Manchester, UK
14University ofExeter Medical School, University ofExeter, Exeter, UK
15School ofSocial & Community Medicine, University ofBristol, Bristol, UK
*Corresponding author
†In memoriam

Declared competing interests of authors: SimonGilbody isaHealth Technology Assessment Clinical
Evaluation and Trials Board Member.Michael Barkham isa developer of the Clinical Outcomes in Routine
Evaluation –Outcome Measure, which was used as asecondary outcome measure in thetrial. Peter Bower
reports personal fees from paid consultancy for theBritish Association of Counselling and Psychotherapy,
outside thesubmitted work. Karina Lovell is aNon-Executive Director for Manchester Mental Health and
Social Care Trust and is paidasalary.
Published December 2015
DOI: 10.3310/hta191010
This reportshould be referenced as follows:
Littlewood E, Duarte A, Hewitt C, Knowles S, Palmer S, Walker S, et al. Arandomised controlled
trial of computerised cognitive behaviour therapy for the treatment of depression in primary care:
theRandomised Evaluation of the Effectiveness andAcceptability of Computerised Therapy
(REEACT) trial. Health Technol Assess 2015;19(101).
HealthTechnology Assessment isindexed and abstracted in IndexMedicus/MEDLINE, Excerpta
Medica/EMBASE, ScienceCitation Index Expanded (SciSearch®) andCurrent Contents®/
Clinical Medicine.

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DOI:10.3310/hta191010 HEALTHTECHNOLOGYASSESSMENT2015 VOL.19 NO.101
Abstract
A randomised controlled trial of computerised cognitive
behaviour therapy for the treatment of depression in
primary care: the Randomised Evaluation of the
Effectiveness and Acceptability of Computerised Therapy
(REEACT) trial
Elizabeth Littlewood,1 Ana Duarte,2 Catherine Hewitt,3
Sarah Knowles,4,5 Stephen Palmer,2 Simon Walker,2 Phil Andersen,1
Ricardo Araya,6,7 Michael Barkham,8 Peter Bower,5 Sally Brabyn,1
Gwen Brierley,1,9 Cindy Cooper,10 Linda Gask,5 David Kessler,11
Helen Lester,5,12† Karina Lovell,13 Usman Muhammad,3 Glenys Parry,10
David A Richards,1,14 Rachel Richardson,1 Debbie Tallon,15
Puvan Tharmanathan,3 David White10 and Simon Gilbody1*
on behalf of the REEACT Team
1Department of HealthSciences, University of York, York, UK
2Centre forHealth Economics, University ofYork, York, UK
3YorkTrials Unit,Department ofHealth Sciences, University ofYork, York, UK
4Centre forPrimary Care, Institute ofPopulation Health, University ofManchester,
Manchester, UK
5National Institute for HealthResearch (NIHR) School for PrimaryCare Research, Manchester
Academic Health Science Centre,University ofManchester, Manchester, UK (previously National
Primary CareResearch and Development Centre,University ofManchester, Manchester, UK)
6Academic Unit of Psychiatry, University ofBristol, Bristol, UK
7DepartmentofPopulationHealth,LondonSchoolofHygieneandTropicalMedicine,London,UK
8Centre forPsychological Services Research, University ofSheffield, Sheffield, UK
9Medical Research Council (MRC) Epidemiology Unit, University of Cambridge School ofClinical
Medicine, Cambridge, UK
10Clinical Trials Research Unit, School ofHealth and Related Research, University of Sheffield,
Sheffield, UK
11Academic Unit ofPrimary Health Care, University of Bristol, Bristol, UK
12Primary CareClinical Sciences, University ofBirmingham, Birmingham, UK
13School ofNursing, Midwifery and Social Work, University of Manchester, Manchester, UK
14University ofExeter Medical School, University ofExeter, Exeter, UK
15School ofSocial & Community Medicine, University ofBristol, Bristol, UK
*Corresponding author [email protected]
†In memoriam
©Queen’sPrinterandControllerofHMSO2015.ThisworkwasproducedbyLittlewoodetal.underthetermsofacommissioningcontractissuedbytheSecretaryofStatefor
Health.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournals vii
providedthatsuitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe
addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonScience
Park,SouthamptonSO167NS,UK.
ABSTRACT
Background: Computerised cognitive behaviour therapy (cCBT) hasbeen developed as anefficient form
of therapy delivery with thepotential to enhance accessto psychological care. Independent research is
needed which examines both the clinical effectiveness andcost-effectiveness of cCBT over theshort and
longer term.
Objectives: To compare the clinical effectiveness and cost-effectiveness of cCBT as anadjunct to usual
general practitioner (GP) care againstusual GPcare alone,for afree-to-use cCBT program (MoodGYM;
National Institute for Mental HealthResearch, Australian National University, Canberra, Australia) and a
commercial pay-to-use cCBT program (Beating theBlues®; Ultrasis, London, UK) for adults with depression,
and to determine the acceptability of cCBT and theexperiences of users.
Design: A pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT)with concurrent
economic andqualitative evaluations. Simple randomisation was used.Participants and researchers were
not blind to treatment allocation.
Setting: Primary carein England.
Participants: Adults with depression who scored ≥10 onthe Patient Health Questionnaire-9 (PHQ-9).
Interventions: Participants whowere randomised to either of thetwo intervention groups receivedcCBT
(Beating theBlues or MoodGYM) in additionto usualGP care. Participants whowere randomised to the
control groupwere offered usualGP care.
Main outcome measures: Theprimary outcome was depression at 4months (PHQ-9). Secondary
outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of
life at 4, 12and 24 months; treatment preference; and theacceptability of cCBT and experiences of users.
Results: Clinical effectiveness: 210 patients were randomised to Beating the Blues, 242 patients were
randomised to MoodGYM and 239 patients were randomised to usual GP care(total 691).There was no
difference in theprimary outcome (depression measured at 4months) either between Beating the Blues
and usual GPcare [odds ratio (OR)1.19, 95% confidence interval (CI)0.75 to 1.88] or between
MoodGYM and usualGP care (OR 0.98,95% CI 0.62 to 1.56). There was nooverall difference across all
time points for either intervention compared with usualGP carein amixed model(Beating the Bluesversus
usual GP care, p=0.96; and MoodGYMversus usualGP care, p=0.11). However, asmall but statistically
significant difference between MoodGYM and usual GPcare at 12 months was found(OR 0.56, 95% CI
0.34 to 0.93). Free-to-use cCBT (MoodGYM) was notinferior to pay-to-use cCBT (Beating theBlues)
(OR 0.91, 90% CI 0.62 to 1.34; p=0.69). There were no consistent benefits of either intervention when
secondary outcomes were examined. There were noserious adverse events thoughtlikely to berelated to
the trial intervention. Despite theprovision of regular technical telephone support, therewas low uptake
of thecCBT programs. Cost-effectiveness: cost-effectiveness analyses suggest that neither Beating the
Blues norMoodGYM appeared cost-effective comparedwith usual GP carealone.Qualitative evaluation:
participants were often demotivated to accessthe computer programs, by reason of depression. Some
expressed theview that agreater level of therapeutic input would beneeded to promote engagement.
Conclusions: The benefits that have previously been observedin developer-led trials were not foundin
this large pragmatic RCT. The benefits of cCBT when addedto routine primary care were minimal, and
uptake of this mode of therapy was relatively low.There remains a clinical and economic need for effective
low-intensity psychological treatments for depression with improved patient engagement.
Trial registration: This trial isregistered as ISRCTN91947481.
Funding: This project was funded bythe National Institute for Health Research Health Technology
Assessment programme.
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