Stratified Care vs Stepped Care for Depression : A Cluster Randomized Clinical Trial

Key Points

Question

Is stratified care an efficacious and cost-effective approach to psychological treatment selection compared with stepped care?

Findings

In this cluster randomized clinical trial of 951 adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms relative to stepped care.

Meaning

These findings suggest that stratified care has the potential to improve depression treatment outcomes at a modest incremental cost.

Abstract

This cluster randomized clinical trial assesses whether stratified care is effective and cost-effective compared with usual stepped care among patients seeking psychological treatment for common mental disorders, including depression.

Abstract

Importance

Depression is a major cause of disability worldwide. Although empirically supported treatments are available, there is scarce evidence on how to effectively personalize psychological treatment selection.

Objective

To compare the clinical effectiveness and cost-effectiveness of 2 treatment selection strategies: stepped care and stratified care.

Design, Setting, and Participants

This multisite, cluster randomized clinical trial recruited participants from the English National Health Service from July 5, 2018, to February 1, 2019. Thirty clinicians working across 4 psychological therapy services were randomly assigned to provide stratified (n = 15) or stepped (n = 15) care. In stepped care, patients sequentially access low-intensity guided self-help followed by high-intensity psychotherapy. In stratified care, patients are matched with either low- or high-intensity treatments at initial assessment. Data were analyzed from May 18, 2020, to October 13, 2021, using intention-to-treat principles.

Interventions

All clinicians used the same interview schedule to conduct initial assessments with patients seeking psychological treatment for common mental disorders, but those in the stratified care group received a personalized treatment recommendation for each patient generated by a machine learning algorithm. Eligible patients received either stratified or stepped care (ie, treatment as usual).

Main Outcomes and Measures

The preregistered outcome was posttreatment reliable and clinically significant improvement (RCSI) of depression symptoms (measured using the 9-item Patient Health Questionnaire). The RCSI outcome was compared between groups using logistic regression adjusted for baseline severity. Cost-effectiveness analyses compared incremental costs and health outcomes of the 2 treatment pathways.

Results

A total of 951 patients were included (618 women among 950 with data available [65.1%]; mean [SD] age, 38.27 [14.53] years). The proportion of cases of RCSI was significantly higher in the stratified care arm compared with the stepped care arm (264 of 505 [52.3%] vs 134 of 297 [45.1%]; odds ratio, 1.40 [95% CI, 1.04-1.87]; P = .03). Stratified care was associated with a higher mean additional cost per patient (£104.5 [95% CI, £67.5-£141.6] [$139.83 (95% CI, $90.32-$189.48)]; P < .001) because more patients accessed high-intensity treatments (332 of 583 [56.9%] vs 107 of 368 [29.1%]; χ ² = 70.51; P < .001), but this additional cost resulted in an approximately 7% increase in the probability of RCSI.

Conclusions and Relevance

In this cluster randomized clinical trial of adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms compared with stepped care. Stratified care can improve depression treatment outcomes at a modest additional cost.

Trial Registration

isrctn.org Identifier: ISRCTN11106183