The second Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT-2) Trial
| ISRCTN | ISRCTN55310481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55310481 |
| Secondary identifying numbers | HTA 06/43/504 |
- Submission date
- 08/10/2010
- Registration date
- 20/10/2010
- Last edited
- 06/03/2017
- 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. As part of a study comparing two CBT packages with usual GP care, we wish to assess the clinical and cost effectiveness of the addition of regular telephone support to computerised CBT.
Who can participate?
Patients with depression, aged 18 and over
What does the study involve?
All participants receive usual GP care and computerised CBT (MoodGYM - a free-to use web-based CBT programme for depression). In addition participants are randomly allocated to receive either weekly telephone support calls or no telephone support calls. We examine whether this is effective at reducing the symptoms of depression over a 12-month follow-up period.
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?
January 2011 to May 2015
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
Department of Health Sciences
Seebohm Rowntrees Building (area 4)
University of York
Heslington
York
YO10 5DD
United Kingdom
| sg519@york.ac.uk |
Study information
| Study design | Randomised controlled multicentre study including concurrent economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Sally Brabyn [sally.brabyn@york.ac.uk ] to request a patient information sheet |
| Scientific title | Does the provision of telephone support enhance the effectiveness of therapy? A randomised controlled trial and economic evaluation |
| Study acronym | REEACT-2 |
| Study hypothesis | To establish the clinical and cost effectiveness of the addition of regular telephone support to computerised CBT over a four and 12 month follow-up period. This trial is a sub-study of the REEACT trial. More details may be found at: 1. http://www.isrctn.com/ISRCTN91947481 2. http://www.nets.nihr.ac.uk/projects/hta/064305 |
| Ethics approval(s) | Bradford Research Ethics Committee, 20/12/2010, ref: 10/H1302/95 |
| Condition | Depressive disorder |
| Intervention | Experimental intervention: Usual GP care PLUS computerised CBT (MoodGYM - a free-to use web-based CBT programme for depression) PLUS weekly telephone support calls. Control intervention: Usual GP care PLUS computerised CBT (MoodGYM) |
| Intervention type | Other |
| Primary outcome measure | Depression severity and symptomatology (PHQ-9 >=10), measured by a validated self-report measure (the Patient Health Questionnaire [PHQ-9]) depression score at four months. |
| Secondary outcome measures | Outcome measures as of 01/04/2016: 1. Self-reported depression severity, measured by the 9-item Patient Health Questionnaire (PHQ-9) at four and 12 months as a continuous measure 2. Anxiety, measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 4 and 12 months 3. Somatoform complaints, measured using the Patient Health Questionnaire 15 (PHQ-15) at 4 and 12 months 4. Health state utility, measured using EuroQol (EQ5D) at 4 and 12 months Original secondary outcome measures: 1. PHQ-9 measured at 12 months And the following outcome measures at both 4 and 12 months: 2. Anxiety, measured using the Generalised Anxiety Disorder Assessment (GAD-7) 3. Somatoform complaints, measured using the Patient Health Questionnaire 15 (PHQ-15) 4. Health-related quality of life, measured using the Short-Form 12 (SF-12) 5. Health state utility, measured using EuroQol (EQ5D) at 4, 12 and 24 months |
| Overall study start date | 04/01/2011 |
| Overall study end date | 31/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 350, 175 per study arm |
| Participant inclusion criteria | 1. Adult patients, aged 18 years and above 2. Depression defined as a score of greater than or equal to 10 on the PHQ9 depression severity instrument 3. Not currently in receipt of computerised CBT or specialist psychological therapy 4. Patients may be with or without either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety 5. Both incident and prevalent cases 6. 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 7. Patients with previous treatment experience of CBT will not be excluded |
| Participant exclusion criteria | 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. |
| Recruitment start date | 04/01/2011 |
| Recruitment end date | 05/04/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
YO10 5DD
United Kingdom
Sponsor information
University/education
c/o Sue Final
University of York
Research Innovation Office
Innovation Centre
York Science Park
York
YO10 5DD
England
United Kingdom
"ROR" |
https://ror.org/04m01e293 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of study results in a peer reviewed journal and as a HTA monograph. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No | |
| Results article | results | 01/05/2017 | Yes | No |
Editorial Notes
06/03/2017: Publication reference added.
07/12/2016: Publication reference added.
24/05/2016: The publication and dissemination plan and availability of the participant level data has been added.
12/05/2016: Plain English summary added.
01/04/2016: Ethics approval information added and the secondary outcome measures have been updated. The overall trial end date has been updated from 30/12/2012 to 31/05/2015 and the recruitment end date has been updated from 30/12/2012 to 05/04/2014. In addition, the target number of participants has been updated from 200 to 350, to allow detection of a smaller difference of 0.30 with 80% power at a level of significance of 0.05 (one-sided) accounting for loss to follow up of 20% (received REC approval in 2012).
