Depression: Should Stratified Care Be the Go-To Treatment Pathway?

A stratified psychological health care approach, in which patients were assigned to treatments based on the complexity of their condition, led to higher rates of reliable and clinically significant improvement (RCSI) in depression symptoms compared to a traditional stepped care approach but also incurred moderately higher treatment costs, researchers found.

Clinical guidelines for the management of patients with depression recommend a stepped care approach to psychological interventions—patients are primarily started on low-intensity treatments and then, if they remain symptomatic, they can access more intensive and costly therapies until they find the appropriate treatment to suit their specific needs.

The stepped approach was implemented at a national level in England through the Improving Access to Psychological Therapies (IAPT) program, and the approach has been associated with large effect sizes for depression. However, “these effects were attenuated in subgroups of patients with more complex presentations, such as those with comorbid physical illnesses, personality disorder traits, disabilities, and low treatment expectancies and those living in socioeconomically deprived circumstances,” Jaime Delgadillo, PhD, of the University of Sheffield in Sheffield, U.K., and colleagues explained in JAMA Psychiatry.

“These complicating factors have a cumulative effect, such that patients with several of these features tend to have poorer treatment outcomes,” they wrote. “On this basis, some have argued that IAPT services should move toward a stratified approach to psychological treatment selection, which would involve matching the intensity of treatment to the level of complexity in each individual case.”

For their multisite, cluster randomized clinical trial, Delgadillo and colleagues recruited participants from the English National Health Service from July 5, 2018 to Feb. 1, 2019 and randomized them to treatment by clinicians who provided either stratified or stepped care.

The study authors found that, compared to a stepped care approach, “stratified care improves depression outcomes, albeit at an incremental cost per treatment. This improvement comes with no effect on drop-out rates, despite the fact that significantly more patients in the stratified care group accessed high-intensity treatments, which have longer waiting lists. Dropout rates in the present study and across both trial arms (approximately 30%) were consistent with data from IAPT services. Furthermore, the stratified care model was feasible to implement and had a high adherence rate (κ= 0.81). Treatment selection decisions made in the stepped care group had nearly chance-level convergence with those in the stratified care algorithm (κ= 0.22), indicating that decision-making across these models is highly distinctive. Stratified care also increased the efficiency of initial assessments, because clinicians in the experimental group were able to assess a larger sample of patients in the same allotted weekly time, whereas decisions in the stepped care group were sometimes protracted by the need to consult with colleagues or supervisors about suitability for available treatments, which is commonplace in stepped care.”

However, contrary to their expectations prior to the trial, Delgadillo and colleagues reported that only more standard, less complex cases had significantly improved outcomes with stratified care.

“In the present study, relatively few patients with the poorest expected prognosis were classified as complex cases (225 of 951 [23.7%]), and it may be that the observed trend toward better outcomes in stratified care for the complex cases could be diluted by the inclusion of some patients with chronic conditions that simply do not respond to interventions available in IAPT services,” they wrote. “Previous research suggests that the presence of patients with chronic conditions in a clinical sample may obscure the differential treatment response in those with more treatable conditions. It is, of course, possible that stratified care does not work for complex cases as defined in this study, and future research should consider how to improve outcomes for those at the highest risk of poor treatment response.”

Despite this unexpected finding, the study authors concluded that stratified care can be feasibly implemented into routine IAPT services in the U.K. and improve the efficiency and precision of psychological assessments while still maintaining shared decision-making.

For their analysis, Delgadillo and colleagues recruited 30 clinicians practicing across four psychological therapy services; these clinicians were randomized 1:1 to provide either stratified care (n=15) or stepped care (n=15). The study authors also recruited patients who were seeking treatment for a common mental disorder (unipolar depression, posttraumatic stress disorder, obsessive-compulsive disorder, body dysmorphic disorder, phobias, and other anxiety disorders) and were deemed suitable for treatment in the IAPT program according to clinical guidelines.

Patients randomized to receive stepped care sequentially accessed low-intensity, guided self-help, followed by high-intensity psychotherapy as required; patients randomized to stratified care were assigned to either low-intensity or high-intensity treatments at initial assessment according to patient-reported measures of depression, anxiety, functional impairment, personality traits, employment status, and race and ethnicity. Cases classified as standard, or having a better expected prognosis, were matched to low-intensity care with the option to move to high-intensity care if needed, while cases classified as complex were immediately matched to high-intensity treatments.

The study’s primary outcome was post-treatment RCSI of depression symptoms as measured by the 9-item Patient Health Questionnaire (PHQ-9). With this tool, scores range from 0 to 27, with a change of at least 6 points indicative of a statistically reliable change; to achieve RCSI, patients needed to achieve a score of less than 10 and an improvement of 6 points or more. The authors also conducted a cost-efficacy analysis to compare the incremental costs and health outcomes of the two treatment strategies.

Ultimately, 951 patients met eligibility criteria (583 in the stratified care group and 368 controls; 618 women [65.1%] and 332 men [34.9%] among 950 with data available; mean [SD] age, 38.27 [14.53] years; 95.3% White). Of these, a portion that did not score above the clinical cutoff in the PHQ-9 (n=149 [15.7%]) were excluded from the primary analysis but included in secondary analyses.

“Overall, in the full sample, patients in the stratified care group had significantly better depression (PHQ-9) treatment outcomes (RCSI: 264 of 505 [52.3%] versus 134 of 297 [45.1%]; OR, 1.40 [95% CI, 1.04-1.87]; P=0.03),” Delgadillo and colleagues wrote. “Patients in the stratified care group were also significantly more likely to meet criteria for IAPT reliable recovery (276 of 573 [48.2%]) after treatment compared with patients in the stepped care group (152 of 348 [43.7%]; OR, 1.33 [95% CI, 1.01-1.75]; P=0.04).”

In subgroup analyses, “between-group differences in depression outcomes were not significant in the subsample of complex cases (RCSI: 63 of 160 [39.4%] versus 22 of 65 [33.8%]; OR, 1.28 [95% CI, 0.70-2.35]; P=0.42), but they were significant in the subsample of standard cases (RCSI: 201 of 345 [58.3%] versus 112 of 232 [48.3%]; OR, 1.50 [95% CI, 1.07-2.09]; P=0.02),” they added. “Between-group comparisons in the anxiety outcome measure were not statistically significant (e.g., full-sample RCSI, 266 of 538 [49.4%] versus 151 of 327 [46.2%]; OR, 1.19 [95% CI, 0.90-1.57]; P=0.22).”

The study authors also found that stratified care was linked to a higher mean additional cost per patient (£104.5 [95% CI, £67.5-£141.6] [$139.83 (95% CI, $90.32-$189.48)]; P<0.001), but this was due to the fact that more patients in this group accessed high-intensity treatments (32 of 583 [56.9%] versus 107 of 368 [29.1%]; χ²=70.51; P<0.001); and, what’s more, this additional cost led to a roughly 7% increase in the probability of a patient achieving RCSI.

Study limitations included self-reported patient outcomes; disorder-specific measures weren’t available for conditions such as PTSD and OCD; the predominantly White study cohort limits generalizability; a lack of data on long-term outcomes; and the analysis did not include wider outcomes such as quality-adjusted life-years and use of health care services at the end of treatment.

1. A stratified psychological health care approach, in which patients were assigned to treatments based on the complexity of their condition, led to higher rates of reliable and clinically significant improvement (RCSI) in depression symptoms compared to the standard stepped care approach, according to findings from a cluster randomized trial from England.

2. The stratified care approach led to moderately higher costs compared to stepped care, but that additional cost was associated with a roughly 7% increase in the probability of RCSI.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 55

Topic ID: 87,55,730,192,55,921