More rapid treatment
Over the course of the baseline year and the 4 years of the MindMap program, almost 1,500 individuals were assessed. Of these, approximately 200 were eligible, and almost all were enrolled.
The researchers measured DUP at two time points from the onset of psychosis – the initiation of antipsychotic treatment (DUP1) and the initiation of FES care. Across the study period, they found that DUP1 fell significantly between the pre- and postprogram assessments, from 329 days to 185 days (P = .03). By contrast, there was no change over the same period for the Prevention and Recovery in Early Psychosis FES program in Boston, which served as a comparator.
There was also a cumulative effect on DUP, with each year of the 4-year program associated with a 46-day reduction in DUP1. However, the significant reduction was restricted to the third quintile of DUP1 and was not found in the other quintiles of DUP1 or for DUP2, despite all measures showing a consistent trend for reduction over time.
Dr. Srihari acknowledges that the team was “disappointed” that DUP2 did not fall significantly in their study. He suggested, “It might take longer for agencies to change their workloads and refer patients to STEP, which is what ended up resulting in the DUP2 not dropping as quickly.”
To see whether there was indeed a time lag in changes to practice, the team conducted an analysis in which they cut out the first year from the results and analyzed only the last 3 years. Then “we do see a decline in DUP2,” he said.
The study’s full results are currently being prepared for publication, and the investigators are considering relaunching the initiative.
“The question we are having now is how to resource the campaign without the research funds and which parts of it we think we can launch sustainably so we can continue the reduction of DUP,” Dr. Srihari said.
Plans may include developing partnerships with local businesses to help fund the media costs and working with the state government to build a learning health care network, which would make it easier for mental health agencies to consult with the team on problematic cases.
“We’re trying to reduce DUP referrals on the supply side by providing this kind of learning health collaborative ... that we also think might be fiscally a more sustainable way to do this vs. what we did in MindMap,” which would be “very expensive” to implement on a statewide basis, Dr. Srihari added.
Long-term benefit
In the second study, Dr. Robinson and colleagues highlight that EISs have been implemented worldwide for FEP patients and have been associated with improved outcomes.
However, these services typically provide care for a limited period, and cross-sectional follow-up studies have identified few advantages in comparison with standard care.
To provide a more robust longitudinal assessment of the ongoing effects of an EIS, the team conducted a 5-year follow-up of the first U.S.-based, multicenter, randomized clinical trial comparing an EIS, NAVIGATE, with usual clinical care in FEP.
RAISE-ETP was conducted at 34 sites across the United States. Seventeen sites provided NAVIGATE to 223 individuals with FEP, and the remaining 17 sites provided usual care to 181 patients.
NAVIGATE, which continued for 2 years, consisted of treatments and services delivered by a coordinated team of providers. Those services included the following:
- Education on schizophrenia and its treatment for patients and their families.
- Symptom and relapse prevention medication, using a computerized decision support system.
- Strategies for illness management building personal resilience.
- A supported employment/education model.
Patients were assessed every 6 months for up to 60 months via a video link using the Heinrichs-Carpenter Quality of Life Scale (QLS) and the Positive and Negative Syndrome Scale (PANSS).
The average age of the participants was 23 years; 78% of those who received NAVIGATE and 66% of those who received usual care were male. The opportunity for each participant to engage in NAVIGATE treatment lasted an average of 33.8 months. The longest was 44.4 months.
Over 5 years, NAVIGATE was associated with a significant improvement over usual care in QLS scores by an average of 13.14 units (P < .001). PANSS scores improved by an average of 7.73 units (P < .002). QLS scores were not affected either by the length of opportunity to participate in NAVIGATE or by DUP, the team reports. Patients who received NAVIGATE also had an average of 2.5 fewer inpatient days, compared with those on usual care (P = .02).
The investigators note that the study “provides compelling evidence of a substantial long-term benefit for FEP treatment with the NAVIGATE EIS, compared with standard care.”
A ‘great message’
Commenting on the findings in an interview, Ragy R. Girgis, MD, associate professor of clinical psychiatry at Columbia University, New York, and the New York State Psychiatric Institute, said
Dr. Girgis, who was not involved in either study, said that the research is “a great message.” He noted that it is “really important for people to know and it’s really important that we’re still doing research in those areas.”
However, he noted that psychosocial interventions such as these “sometimes take a lot of work.” Dr. Girgis said that it is “so easy to just give people a medication” but that approach has its own disadvantages, including adverse effects and sometimes a lack of efficacy.
“Psychosocial interventions, on the other hand, are very well tolerated by people. They are very effective, but they may require a lot more manpower, and in some ways they can also be more expensive.
“So this is a dialectic that we oftentimes have to deal with when we figure out the right balance between psychosocial vs. medication types of treatments,” he said.
STEP has received research funding from the National Institutes of Health and the Patrick and Catherine Weldon Donaghue Medical Research Foundation. RAISE-ETP was funded by the National Institute of Mental Health as part of the Recovery After an Initial Schizophrenia Episode (RAISE) Project. Dr. Gopal is an employee of Janssen Research & Development, and owns stock/equity in Johnson & Johnson. Dr. Girgis has received research support from Genentech, BioAdvantex, Allegran/Forest, and Otsuka, and royalties from Wipf and Stock and Routledge/Taylor and Francis.
A version of this article originally appeared on Medscape.com.