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
jaime.delgadillo@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jaime Delgadillo
ORCID ID
Contact details
Mental Health and Addiction Research Group
Area 4
ARRC Building
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 32 1633
jaime.delgadillo@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15/LO/2200
Study information
Scientific title
Multi-site randomised controlled trial of outcome feedback in IAPT services
Acronym
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
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Common mental health problems (depression, anxiety)
Intervention
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
Other
Phase
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
01/10/2015
Overall trial end date
01/08/2017
Reason abandoned (if study stopped)
Eligibility
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
Adult
Gender
Both
Target number of participants
80
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
22/01/2016
Recruitment end date
29/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Whittington Health NHS Trust
Magdala Ave
London
N19 5NF
United Kingdom
Trial participating centre
Barnet, Enfield and Haringey Mental Health Trust
London
EN1 3SZ
United Kingdom
Trial participating centre
Pennine Care NHS Foundation Trust
Hyde
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
Cheshire
CW7 2AS
United Kingdom
Sponsor information
Organisation
University of York
Sponsor details
Research Innovation Office
Innovation Centre
York Science Park
York
YO10 5DG
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of York
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
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
01/12/2017
Participant level data
Other
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29937396