Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Psychological interventions (treatments such as counselling, or talking therapy) can be helpful for people with depression and anxiety problems; however not all patients respond well to therapy and some people deteriorate (get worse). Monitoring patients’ response to therapy using short questionnaires can be a useful way to identify people who may not be progressing well or might get worse. An individual patient’s response during treatment can be compared to so-called “norms” derived by observing how hundreds of similar patients’ symptoms change over time. Using this method, it is possible to identify patients who are ‘not on track’. Previous studies have shown that alerting therapists and patients when therapy is ‘not on track’ can actually help to prevent deterioration and to improve outcomes. This method is called ‘outcome feedback’. Although outcome feedback (OF) has been shown to be work well in the USA and other European countries, this technology has not been robustly tested in primary care psychological services in the United Kingdom. Our study aims to assess how this technology performs when used for as part of the NHS run IAPT (Improving Access to Psychological Therapies) programme in England.

Who can participate?
Qualified clinicians providing psychological therapies in IAPT services.

What does the study involve?
Psychological therapists are allocated to either the intervention group or control group, depending on their IAPT service. Those in the control group treat their patients as usual. Those in the intervention group track the progress of all their patients by asking them to fill in questionnaires on how they are feeling. The results from the questionnaires are plotted onto a chart which shows changes from session to session. These results are compared with a chart showing the expected rate of improvement over the course of the treatment. Patients that are “not on track” are then identified so that appropriate action can be taken.

What are the possible benefits and risks of participating?
Patients identified as ‘not on track’ during therapy may be less likely to deteriorate if they are treated by therapists that use OF. No risks or adverse effects are expected.

Where is the study run from?
Five NHS Trusts in England are taking part.

When is the study starting and how long is it expected to run for?
October 2015 to August 2017.

Who is funding the study?
University of York (UK)

Who is the main contact?
Dr Jaime Delgadillo

Trial website

Contact information



Primary contact

Dr Jaime Delgadillo


Contact details

Mental Health and Addiction Research Group
Area 4
ARRC Building
Department of Health Sciences
University of York
YO10 5DD
United Kingdom
+44 (0)1904 32 1633

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Multi-site randomised controlled trial of outcome feedback in IAPT services


Study hypothesis

Patients with depression / anxiety symptoms who are potentially at risk of poor outcomes (not-on-track) will be less likely to deteriorate if they are treated by therapists that have access to Outcome Feedback (OF) technology, by comparison to usual psychological care (without OF).

Ethics approval

London - City & East NHS Research Ethics Committee, 06/01/2016, ref: 15/LO/2200

Study design

Multi-site open-label cluster randomised controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Common mental health problems (depression, anxiety)


Psychological therapists will be randomly assigned to an outcome feedback (OF) or usual care control group. OF (the experimental intervention) consists of alerting therapists to cases at risk of poor progress in therapy, using real-time outcome tracking and prediction technology.

OF studies track individual patients’ progress using brief questionnaires that measure symptom severity, and the results are plotted into a chart that shows changes from session-to-session. The individual patient’s symptoms are routinely compared to a chart showing the expected rate of improvement over the course of treatment, which is derived from treatment records for a comparable clinical population. Depending on how close the patient’s progress matches the expected recovery chart, cases are flagged up as ‘on track’ or ‘not on track’, and feedback about this is provided to clinicians and patients. This feedback system can be integrated within existing electronic clinical information systems used in routine practice to keep case notes and client data. Research in this field demonstrates that using OF methods can help to improve outcomes for patients at risk of poor progress.

Intervention type



Drug names

Primary outcome measure

Changes in patient-reported depression (PHQ-9), anxiety (GAD-7) and functional impairment (WSAS) questionnaires, measured at each therapy session.

Mean changes in these measures at the end of therapy will be estimated for all patients treated by therapists in the intervention(OF) and control groups, therefore patient data is nested within their respective therapists. Comparisons will be made in the mean differences in the above outcomes between groups.

Secondary outcome measures

1. De-identified clinical and demographic characteristics for patients treated by the participating therapists (diagnosis, age, gender, ethnicity, socioeconomic deprivation, employment, type and duration of psychological treatments received)
2. A battery of questionnaires completed by participating therapists (includes information on clinical practice, training, experience, supervision, job stress & satisfaction, decision-making and coping styles)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Qualified clinicians delivering evidence-based psychological therapies in IAPT* services.

* IAPT = Improving Access to Psychological Therapies, a national programme of mental healthcare in England, United Kingdom.

Participant type

Health professional

Age group




Target number of participants


Participant exclusion criteria

1. Therapists who are not yet fully qualified (e.g. trainees)
2. Qualified therapists whose work contract is shorter than the active study period (1 year)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Whittington Health NHS Trust
Magdala Ave
N19 5NF
United Kingdom

Trial participating centre

Barnet, Enfield and Haringey Mental Health Trust
United Kingdom

Trial participating centre

Pennine Care NHS Foundation Trust
SK14 2BJ
United Kingdom

Trial participating centre

Cambridgeshire and Peterborough NHS Foundation Trial
Cambridge, Huntingdon, Fenland
CB21 5EE
United Kingdom

Trial participating centre

Cheshire and Wirral Partnership NHS Foundation Trust
United Kingdom

Sponsor information


University of York

Sponsor details

Research Innovation Office
Innovation Centre
York Science Park
YO10 5DG
United Kingdom

Sponsor type




Funder type


Funder name

University of York

Alternative name(s)

The University of York

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)


United Kingdom

Results and Publications

Publication and dissemination plan

Results of the trial will be published in scientific journals. Results will also be shared with the participating services at local team meetings and through a research newsletter.

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

2018 results in:

Publication citations

Additional files

Editorial Notes

26/06/2018: Publication reference added.