| ISRCTN | ISRCTN11106183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11106183 |
| Secondary identifying numbers | 152958 |
- Submission date
- 25/07/2018
- Registration date
- 27/07/2018
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Patients with depression and anxiety problems accessing the English National Health Service are commonly referred for psychological treatment in IAPT services (Improving Access to Psychological Therapies). IAPT services organise treatment in a stepped care model, where most patients tend to initially receive brief and low intensity interventions before accessing more intensive psychological therapies if required. Recent studies have shown that some patients with more complex clinical presentations tend to drop out and have poor outcomes in low intensity treatments, but they respond better to high intensity treatments. These studies have suggested that referring 'complex cases' directly to high intensity treatments (stratified care) could considerably improve their likelihood of improvement in depression symptoms. The aim of this study is to compare the effectiveness of a stratified care model (where complex cases are matched to high intensity treatments) versus usual stepped-care.
Who can participate?
Therapists and their patients who are eligible for treatment in IAPT
What does the study involve?
Therapists (and patients they assess) are randomly allocated to the StratCare group or the usual care control group. Therapists in the StratCare group are trained to use a computer programme that helps them to identify complex cases and to adequately refer these to high intensity treatments. Control group therapists assess patients and make referrals for treatment in the usual way (based on their clinical judgment and following stepped care principles). Participants’ depression and anxiety are measured before and after treatment.
What are the possible benefits and risks of participating?
The StratCare treatment selection method may result in improved depression symptoms for patients classified as having a complex clinical profile. It is not expected that taking part in the study will lead to any disadvantages or risks to therapists or to any patients.
Where is the study run from?
1. Lancashire Care NHS Foundation Trust (UK)
2. Rotherham, Doncaster and South Humber NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
August 2018 to December 2019
Who is funding the study?
MindLife UK
Who is the main contact?
Dr Jaime Delgadillo
jaime.delgadillo@nhs.net
Contact information
Scientific
Clinical Psychology Unit
University of Sheffield
Cathedral Court, Floor F
1 Vicar Lane
Sheffield
S1 2LT
United Kingdom
 ORCID ID |
0000-0001-5349-230X |
|---|---|
| Phone | +44 (0)114 222 6614 |
| jaime.delgadillo@nhs.net |
Study information
| Study design | Pragmatic cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | https://www.stratcare.co.uk/information/ |
| Scientific title | Pragmatic randomised controlled trial of a stratified care model for depression and anxiety |
| Study acronym | StratCare |
| Study hypothesis | Patients in the StratCare group will have significantly greater improvement in depression symptoms after psychological treatment, compared to those in the usual care control group. It is expected that this effect will be found specifically in the subsample of patients classified as complex cases at the time of initial assessment. |
| Ethics approval(s) | West of Scotland Research Ethics Service, 18/07/18, ref: 18/WS/0114 |
| Condition | Common mental health problems (depression, anxiety) |
| Intervention | Psychological therapists who carry out mental health assessments in routine primary care services will be randomly assigned to an experimental group (StratCare) or a usual care control group. Therapists in the experimental group will have access to a computerized artificial intelligence programme called the StratCare App. The programme prompts therapists to enter (fully anonymized) data for patients who they assess, and uses a machine learning algorithm to recommend a specific type of psychological treatment, based on each patient's characteristics. Control group therapists will assess patients and make referrals for treatment in the usual way (based on their clinical judgment and following stepped care principles). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | Depression measured using PHQ-9 pre (initial assessment) and post-treatment (final therapy session) |
| Secondary outcome measures | 1. Anxiety measured using GAD-7 pre (initial assessment) and post-treatment (final therapy session) 2. Treatment dropout rates, as recorded in routine clinical records 3. Therapists' adherence to the StratCare treatment recommendations, as measured by statistical reliability indices (hit rates, and treatment-matching precision scores) 4. Cost-effectiveness of the StratCare model by comparison to usual care, determined using a cost-effectiveness acceptability curve (CEAC) |
| Overall study start date | 06/08/2018 |
| Overall study end date | 20/12/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 760 cases need to be assessed to identify 226 complex cases (target subsample for primary analysis) |
| Total final enrolment | 951 |
| Participant inclusion criteria | 1. Consenting psychological wellbeing practitioners and psychotherapists that carry out routine assessments in an IAPT service (Improving Access to Psychological Therapies programme in England) 2. Therapists who are employed by a participating IAPT service on a permanent contract, or temporary staff who have a contract that is at least as long as the expected timescale for the project (1 year) 3. All consenting patients who are assessed by participating therapists, who are deemed eligible for treatment in IAPT, and who attend at least one post-assessment therapy session |
| Participant exclusion criteria | 1. Therapists whose contract is shorter than the expected timescale for the study (1 year) 2. Therapists currently in training, since they are not yet fully qualified to carry out routine assessments 3. Patients who are assessed as ineligible for treatment in IAPT (eg, those who are signposted to other services), or eligible patients who never attend any therapy sessions after an initial assessment contact |
| Recruitment start date | 13/08/2018 |
| Recruitment end date | 01/05/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
PR1 8UY
United Kingdom
DN8 5HU
United Kingdom
Sponsor information
University/education
Department of Psychology
University of Sheffield
Cathedral Court
1 Vicar Lane
Sheffield
S1 2LT
England
United Kingdom
| Phone | +44 (0)114 222 6517 |
|---|---|
| psychology@sheffield.ac.uk | |
| Website | https://www.sheffield.ac.uk/psychology/index |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 20/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Additional documents, including a full study protocol, statistical analysis plan and copies of relevant assessment measures are available upon request from the Chief Investigator. These documents have been pre-registered and independently reviewed via the UK Integrated Research Approval System (IRAS). A full description of the StratCare algorithm has been published in a scientific journal and is publicly available at: https://doi.org/10.1037/ccp0000231 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 | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/12/2021 | 09/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol (other) | 18/08/2023 | No | No |
Editorial Notes
18/08/2023: A link to the protocol file was added.
09/12/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
