Condition category
Mental and Behavioural Disorders
Date applied
23/08/2007
Date assigned
24/08/2007
Last edited
02/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many people with depression would like to receive a 'talking treatment' (counselling or psychotherapy). The form of talking treatment that is supported by the greatest amount of evidence is Cognitive Behaviour Therapy (CBT). At the present time, there are too few therapists to treat people with depression. Recently, a form of CBT has been developed that can be delivered by computer. Computerised CBT can be delivered in the patient’s own time (and potentially in their own home) and does not require waiting for a therapist. Several computer packages of CBT have been developed. Some of these are free to use and are available over the internet, whilst some are commercial products and have to be purchased at substantial cost to the NHS. We need more information about the effectiveness of these packages and we need to know whether the additional cost of purchasing commercially available products is a sensible use of limited NHS funds. The aim of this study is to compare two CBT packages to usual GP care.

Who can participate?
Patients aged 18 and over with depression

What does the study involve?
Participants are randomly allocated into three groups. The first group receives usual GP care plus "Beating the Blues", a computerised CBT package. The second group receives usual GP care plus "MoodGYM", a free to use web-based CBT programme for depression. The third group receives usual GP care. We examine whether computerised forms of CBT are effective at reducing the symptoms of depression and at improving quality of life and helping people with depression to resume work or caring. We also examine whether expensive commercial products are any better than freely available programmes, and whether the extra cost is justified. Computerised CBT involves interaction with a computer rather than a trained therapist. Although computers have increasingly become part of modern life, it remains unclear how acceptable this form of treatment is for people with depression. We examine whether people with little or no experience of computers find this form of treatment acceptable, and whether the treatment can be realistically offered in the patient’s own home or in a GP surgery.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of York (UK)

When is the study starting and how long is it expected to run for?
May 2009 to October 2013

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof. Simon Gilbody
sg519@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Simon Gilbody

ORCID ID

Contact details

Area 4
Seebohm Rowntree Building
Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 321370
sg519@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 06/43/05

Study information

Scientific title

The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) Trial

Acronym

REEACT

Study hypothesis

Amended as of 08/10/2008:
1. To establish the clinical and cost effectiveness of the addition of computerised cognitive behavioural therapy (CBT) to usual General Practitioner (GP) care over a two year follow-up period
2. To establish the acceptability (to patients and clinicians) of computerised CBT
3. To establish the differential clinical and cost effectiveness of a free-to-use computerised package, in comparison to a commercial pay-to-use computerised CBT package over a two year and longer-term time horizon

Initial information at time of registration:
Our objectives are:
1. To establish the clinical and cost effectiveness of computerised Cognitive Behavioural Therapy (CBT) in comparison with anti-depressant medication over a two year follow-up period
2. To establish the acceptability (to patients and clinicians) of computerised CBT in comparison with anti-depressant medication
3. To establish the differential clinical and cost effectiveness of a free-to-use computerised package, in comparison to a commercial computerised CBT package over a two year and longer-term time horizon
4. To establish the impact of initial patient preference for computerised CBT on clinical and cost effectiveness of computerised CBT

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/064305
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51438/PRO-06-43-05.pdf

Ethics approval

National Research Ethics Service, 10/07/2008

Study design

Fully randomised controlled multicentre study including a concurrent economic and qualitative evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depressive disorder

Intervention

Amended as of 08/10/2008:
Experimental Group 1: usual GP care plus "Beating the Blues", a computerised cognitive behavioural therapy package
Experimental Group 2: usual GP care plus "MoodGYM", a free to use web-based CBT programme for depression
Control Intervention: usual GP care

Initial information at time of registration:
Experimental Group 1: "Beating the Blues", a computerised cognitive behavioural therapy package
Experimental Group 2: "MoodGYM", a free-to use web-based CBT programme for depression
Control Intervention: Anti-depressants prescribed by patient's general practitioner in line with normal GP practice

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Depression severity and symptomatology as measured by a validated self-report measure (the Patient Health Questionnaire [PHQ-9]) and the International Classification of Diseases (ICD-10) depression score at four months.

Secondary outcome measures

1. PHQ-9 at 12 and 24 months
2. Generic and global mental health (Clinical Outcomes in Routine Evaluation-Outcome Measure [CORE-OM]) at 4, 12 and 24 months
3. Health related quality of life (the Short-Form 36 [SF-36] v2) at 4, 12 and 24 months
4. Health state utility (EuroQol [EQ5D]) at 4, 12 and 24 months

Overall trial start date

01/05/2009

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Amended as of 08/10/2008:
Adult patients, aged 18 years and above with depression who are not currently in receipt of computerised CBT or specialist psychological therapy. Our inclusion threshold will be a score of greater than or equal to 10 on the PHQ9 depression severity instrument. We will also include patients with either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety. We will include both incident and prevalent cases. In line with the pragmatic nature of this trial, we will reflect usual GP care and participants will be eligible to participate whether they are in receipt of antidepressant medication or not. Patients with previous treatment experience of CBT will not be excluded.

Initial information at time of registration:
Adult patients aged 18 and above with depression who are being considered for anti-depressant drug treatment and for whom computerised therapy represents a non-drug alternative (within a stepped care framework). We will also include patients with either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

Amended as of 08/10/2008:
1. Actively suicidal
2. Suffering psychotic symptoms
3. Depressed in the post-natal period
4. Have recently suffered bereavement
5. Cases of psychotic depression; since computerised therapy is not recommended within NICE guidance, and are also unlikely to be recruited or randomised by general practitioners to receive computerised CBT, since they are unlikely to have sufficient equipoise in this case

Initial information at time of registration:
1. Actively suicidal
2. Suffering psychotic symptoms
3. Depressed in the post-natal period
4. Have recently suffered bereavement
5. Patients already in receipt of anti-depressants
6. Women who are pregnant, or planning to become pregnant (added as of 29/04/2008)

Recruitment start date

01/05/2009

Recruitment end date

31/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Heslington Road
York
YO10 5DD
United Kingdom
+44 (0)1904 430000
cr14@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26559241
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26685904
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26621513

Publication citations

Additional files

Editorial Notes

21/04/2016: Plain English summary added. 22/12/2015: Publication reference added. 04/09/2009: The overall trial start and end dates were changed from 01/01/2009 and 30/06/2013 to 01/05/2009 and 31/10/2013, respectively. 08/10/2008: The overall trial start and end dates were changed from 01/07/2008 and 30/12/2012 to 01/01/2009 and 30/06/2013, respectively.