StratCare Trial 2: Evaluating the Clinical and Cost-effectiveness of AI-driven Stratified Care for Depression

Summary

Depression and anxiety are common mental health problems affecting around one in six adults. Treatments include therapy, telephone or group-based activities delivered by therapists. Treatment uses a "stepped care" model where most patients start with very brief treatments. If they remain unwell after this, they access longer and more intensive therapy. This model does not always work, as only one out of two patients fully recover.

The researchers have developed an artificial intelligence tool called "StratCare". It is designed to help health services to offer the best available treatment for each patient. StratCare is a computerised system that guides therapists on how to assess new patients. It asks a few questions about their symptoms, personality, and background. The system makes a recommendation about which treatment might be most effective for that person. This is either starting with brief therapy or starting with intensive therapy. The treatments are already used with depression in the National health Service (NHS). The patient can discuss with their therapist and decide whether to accept the recommendation. Otherwise, they can discuss trying other options. Previous research found that StratCare can help more people to recover from depression compared to the usual stepped care model.

The researchers will investigate if the StratCare tool works on a large scale in the NHS and if it helps patients in the long-term. The researchers will run a trial involving 1252 participants using NHS Talking Therapies services. Half will use the StratCare tool to make a treatment recommendation. The other half will follow the stepped care approach. The researchers will contact participants in the trial after 6, 12 and 18 months to see if their mood and quality of life has improved. The researchers will also interview therapists and participants to see what they think about treatment being guided by the StratCare tool.

Hypotheses:

* Stratified care will result in lower mean depression scores compared to usual stepped care (USC).
* Stratified care will result in a statistically significant higher proportion of cases with reliable and clinically significant improvement in depression symptoms, compared to USC.

Primary Outcome:

Depressive symptoms, as measured by change on the Patient Health Questionnaire (PHQ-9), at 12 months post-enrolment.

Conditions

• Depression

Interventions

DEVICE

StratCare

The StratCare app is a technology that collects data, processes inputs using a machine learning algorithm, and outputs a personalised treatment recommendation using automated decision rules. The inputs for the algorithm include patient-reported measures of depression, anxiety, functional impairment, personality traits, employment status and ethnic background. The algorithm calculates an expected prognosis (i.e., a probability of full remission of depression and anxiety symptoms after treatment), based on which patients are classified as standard (better expected prognosis) or complex cases. Standard cases are matched to low-intensity treatments and later have the option to move to high-intensity, whereas complex cases are matched directly to high-intensity treatments. In addition, the StratCare app is programmed to implement decision rules that ensure compliance with national clinical guidelines for the treatment allocation of patients with specific disorders.

Sponsors & Collaborators

• University of Sheffield

  collaborator OTHER

• FSA Research Consulting Inc

  collaborator UNKNOWN

• Rotherham Doncaster and South Humber NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Jaime Delgadillo, Prof · University of Sheffield

• Michael Barkham, Prof · University of Sheffield

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-07

Primary Completion

2026-05-31

Completion

2026-11-30

Countries

• United Kingdom

Study Locations