Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
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. 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

Trial website

Contact information



Primary contact

Prof Simon Gilbody


Contact details

Department of Health Sciences
Seebohm Rowntrees Building (area 4)
University of York
YO10 5DD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 06/43/504

Study information

Scientific title

Does the provision of telephone support enhance the effectiveness of therapy?: A randomised controlled trial and economic evaluation



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:

Ethics approval

Bradford Research Ethics Committee, 20/12/2010, ref: 10/H1302/95

Study design

Randomised controlled multicentre study including concurrent economic evaluation

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please contact Sally Brabyn [ ] to request a patient information sheet


Depressive disorder


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



Not Applicable

Drug names

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


Reason abandoned


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 type


Age group




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

United Kingdom

Trial participating centre

University of York
YO10 5DD
United Kingdom

Sponsor information


University of York (UK)

Sponsor details

c/o Sue Final
University of York
Research Innovation Office
Innovation Centre
York Science Park
YO10 5DD
United Kingdom

Sponsor type




Funder type


Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

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

Publication summary

Publication citations

Additional files

Editorial Notes

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).