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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 White 10, Simon Gilbody 1,*,

1 Department of Health Sciences, University of York, York, UK
2 Centre for Health Economics, University of York, York, UK
3 York Trials Unit, Department of Health Sciences, University of York, York, UK
4 Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK
5 National Institute for Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK
6 Academic Unit of Psychiatry, University of Bristol, Bristol, UK
7 Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK
8 Centre for Psychological Services Research, University of Sheffield, Sheffield, UK
9 Medical Research Council (MRC) Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, UK
10 Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK
11 Academic Unit of Primary Health Care, University of Bristol, Bristol, UK
12 Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK
13 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK
14 University of Exeter Medical School, University of Exeter, Exeter, UK
15 School of Social & Community Medicine, University of Bristol, Bristol, UK
* Corresponding author Email: simon.gilbody@york.ac.uk

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The full text of this issue is available as a PDF document from the Toolkit section on this page.

The full text of this issue is available as a PDF document from the Toolkit section on this page.

Abstract

BACKGROUND

Computerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term.

OBJECTIVES

To compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues(®); Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users.

DESIGN

A pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation.

SETTING

Primary care in England.

PARTICIPANTS

Adults with depression who scored â ¥â 10 on the Patient Health Questionnaire-9 (PHQ-9).

INTERVENTIONS

Participants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care.

MAIN OUTCOME MEASURES

The primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability 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 the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care, pâ =â 0.96; and MoodGYM versus usual GP care, pâ =â 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34; pâ =â 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs. Cost-effectiveness: cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone. Qualitative evaluation: participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement.

CONCLUSIONS

The benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to 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 is registered as ISRCTN91947481.

FUNDING

This project was funded by the National Institute for Health Research Health Technology Assessment programme.

Abstract

BACKGROUND

Computerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term.

OBJECTIVES

To compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues(®); Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users.

DESIGN

A pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation.

SETTING

Primary care in England.

PARTICIPANTS

Adults with depression who scored â ¥â 10 on the Patient Health Questionnaire-9 (PHQ-9).

INTERVENTIONS

Participants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care.

MAIN OUTCOME MEASURES

The primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability 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 the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care, pâ =â 0.96; and MoodGYM versus usual GP care, pâ =â 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34; pâ =â 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs. Cost-effectiveness: cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone. Qualitative evaluation: participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement.

CONCLUSIONS

The benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to 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 is registered as ISRCTN91947481.

FUNDING

This project was funded by the National Institute for Health Research Health Technology Assessment programme.

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