IAPT outcome feedback trial
| ISRCTN | ISRCTN12459454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12459454 |
| Secondary identifying numbers | 15/LO/2200 |
- Submission date
- 07/01/2016
- Registration date
- 14/01/2016
- Last edited
- 26/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Mental Health and Addiction Research Group
Area 4, ARRC Building
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 32 1633 |
|---|---|
| jaime.delgadillo@nhs.net |
Study information
| Study design | Multi-site open-label cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Multi-site randomised controlled trial of outcome feedback in IAPT services |
| Study objectives | 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(s) | London - City & East NHS Research Ethics Committee, 06/01/2016, ref: 15/LO/2200 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2015 |
| Completion date | 01/08/2017 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 22/01/2016 |
| Date of final enrolment | 29/02/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
N19 5NF
United Kingdom
EN1 3SZ
United Kingdom
SK14 2BJ
United Kingdom
CB21 5EE
United Kingdom
CW7 2AS
United Kingdom
Sponsor information
University/education
Research Innovation Office
Innovation Centre, York Science Park
York
YO10 5DG
England
United Kingdom
| Website | http://www.york.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of York, York, Ebor, Universitas Eboracensis
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2018 | Yes | No | |
| Other publications | Cost-effectiveness of feedback-informed psychological treatment: Evidence from the IAPT-FIT trial | 24/04/2021 | 26/10/2021 | Yes | No |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
26/10/2021: Publication reference added.
26/06/2018: Publication reference added.
