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
Prof Simon Gilbody
Department of Health Sciences
Seebohm Rowntrees Building (area 4)
University of York
Does the provision of telephone support enhance the effectiveness of therapy? A randomised controlled trial and economic evaluation
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:
Bradford Research Ethics Committee, 20/12/2010, ref: 10/H1302/95
Randomised controlled multicentre study including concurrent economic evaluation
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please contact Sally Brabyn [firstname.lastname@example.org ] to request a patient information sheet
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)
Primary outcome measures
Depression severity and symptomatology (PHQ-9 >=10) as 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 (as measured by the 9-item Patient Health Questionnaire [PHQ-9]) at four and 12 months as a continuous measure
2. Anxiety as measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 4 and 12 months
3. Somatoform complaints using the Patient Health Questionnaire 15 (PHQ-15) at 4 and 12 months
4. Health state utility (EuroQol [EQ5D]) at 4 and 12 months
Original secondary outcome measures:
1. PHQ-9 at 12 months
And the following outcome measures at both 4 and 12 months:
2. Anxiety as measured using the Generalised Anxiety Disorder Assessment (GAD-7)
3. Somatoform complaints using the Patient Health Questionnaire 15 (PHQ-15)
4. Health-related quality of life using the Short-Form 12 (SF-12)
5. Health state utility (EuroQol [EQ5D]) at 4, 12 and 24 months
Overall trial start date
Overall trial end date
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
Target number of participants
350, 175 per study arm
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
Recruitment end date
Countries of recruitment
Trial participating centre
University of York
Health Technology Assessment Programme
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of study results in a peer reviewed journal and as a HTA monograph.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27922448