The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) Trial
| ISRCTN | ISRCTN91947481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91947481 |
| Secondary identifying numbers | HTA 06/43/05 |
- Submission date
- 23/08/2007
- Registration date
- 24/08/2007
- Last edited
- 02/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
Area 4, Seebohm Rowntree Building
Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321370 |
|---|---|
| sg519@york.ac.uk |
Study information
| Study design | Fully randomised controlled multicentre study including a concurrent economic and qualitative evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) Trial |
| Study 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(s) | National Research Ethics Service, 10/07/2008 |
| 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 |
| Primary outcome measure | 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 study start date | 01/05/2009 |
| Overall study end date | 31/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| 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 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
- England
- United Kingdom
Study participating centre
YO10 5DD
United Kingdom
Sponsor information
University/education
Heslington Road
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 430000 |
|---|---|
| cr14@york.ac.uk | |
| Website | http://www.york.ac.uk |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/11/2015 | Yes | No | |
| Results article | results | 30/11/2015 | Yes | No | |
| Results article | results | 01/12/2015 | Yes | No |
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.
