December 1st, 2015

Early interventions crucial in schizophrenia treatment

“Family psycho education,” “resilience-focused individual therapy,” and “supported employment and education.” All are interventions a team of clinicians provided participants enrolled in a major National Institute of Mental Health funded study of treatment approaches for patients soon after their first schizophrenic episode.

Receiving such coordinated and sustained treatments along with personalized medication management dramatically increased quality of life for the study’s participants over a two-year period compared to usual care emphasizing strong doses of antipsychotic drugs.

And the earlier patients are treated after their first break from reality, the better the outcomes, according to the results of the Recovery After an Initial Schizophrenia Episode (RAISE) clinical trial published in October in The American Journal of Psychiatry.

This first U.S. trial to investigate coordinated first episode psychosis (FEP) treatment programs already implemented in the United Kingdom, Australia, and Canada is generating optimism that a new standard of care will emerge for the early stages of a chronic disorder associated with long-term disability that affects one percent of the general population.

Antipsychotic drugs for treating schizophrenia can have side effects including drowsiness, dizziness, tremors, major weight gain and increased risk of diabetes. Often the side effects are bad enough that many patients stop taking their medication.

“It’s been very exciting, because it’s already having quite an impact,” said Susan Azrin, Ph.D., a Massachusetts native, psychologist and NIMH program chief who serves as government project officer for the RAISE Early Treatment Program. The RAISE initiative began in 2008.

Azrin was referring to the $24.8 million Congress awarded in additional Community Mental Health Services Block Grants to states in January 2014 with a particular call for early intervention after people first experience symptoms like hallucinations, delusions, thought and movement disorders and poor executive functioning.

So far, 32 states, including Massachusetts and Maine, have plans to maintain, expand or develop at least one coordinated specialty care program to better identify FEP individuals by 2016.

Schizophrenia symptoms typically start between ages 16 and 30 with men typically experiencing symptoms at an earlier age than women.

The RAISE study enrolled 404 participants between ages 15 and 40 who were randomly assigned to either of two treatment programs at 34 community mental health centers in 21 states. The mean duration of untreated psychosis was 74 weeks; 71 percent of participants lived with their families.

There were 223 participants assigned to a comprehensive, multidisciplinary team-based approach called NAVIGATE, which provided each center’s clinical staff with additional training and supervision to provide the RAISE interventions.

The other 181 were in the community care control group where treatment was determined by clinician choice and service availability with no additional training offered beyond subject recruitment and retention and data collection.

NAVIGATE participants remained in treatment for a median of 23 months compared to 17 months for the usual care participants.

NAVIGATE participants received more monthly mental health outpatient services, a mean of 4.53, compared to 3.67 for usual care.

NAVIGATE participants also rated more symptom improvement and higher levels of satisfaction in their interpersonal relations, sense of purpose and motivation, and engagement with activities.

Corinne Cather, Ph.D., director of psychological services for the Schizophrenia Clinical and Research Program at Massachusetts General Hospital in Boston and assistant professor of psychology at Harvard Medical School, was a RAISE consulting supervisor.

She listened to audio recordings of sessions with patients and provided feedback to site clinicians during weekly telephone conversations. Cather said the study purposely excluded academic medical centers from serving as treatment sites.

“The thinking was let’s demonstrate that this works in the real world,” Cather said. “And they didn’t even hire study clinicians to work at the sites. They worked with embedded clinicians at the sites. It was kind of a cool thing.”

Among the real world challenges facing the RAISE team was turnover among mental health clinicians. “The training had to take into consideration that people leave the team,” Azrin said.

While medication remains a cornerstone of treatment for people with schizophrenia, Cather is excited to see the other RAISE components play a larger role in illness management. The RAISE decision making tool helped participants feel as though they had a voice in managing their own medication, she said.

“The functional improvements, that’s what we need to do. We need to decrease the disability that’s all too often with schizophrenia,” Cather said.

But Cather noted that while insurance covered individual and family therapy and medication management sessions, grants funded the supported employment component. Supplements will be necessary to make FEP services viable.

“We also need to figure out how do we actually get better intervention services in place in a fragmented health care system? That has been more easily done in European and Australian and Canadian health care systems where it’s just more centralized and easier to identify people,” Cather said.

The study results illuminate the need to see people with schizophrenia as more than their disease, with needs and goals just like anyone else, said James K. Sullivan, M.D., senior vice president and chief medical officer of Butler Hospital in Providence, R.I., which was not involved in the RAISE study.

“Episodes can be minimized,” Sullivan said. “In the periods between episodes, we have a greater responsibility to make sure that those folks are vital and flourishing and functioning and happy and that they can seek relationships, and I think that was the real power of the study for me.”

All of the RAISE trial interventions are offered at McLean OnTrack at McLean Hospital in Belmont, Mass., one of the first few FEP clinics in the U.S., though it was also not part of the trial.

“It’s a very exciting study,” said Kathryn Eve Lewandowski, Ph.D., director of clinical programming at McLean OnTrack said of the findings.
“It’s really validating to see that empirically the RAISE program found the things that we see observationally in the clinic all the time,” Lewandowski said. “Hopefully studies like this will help to convince people at the systems level that these services are really important and are worth paying for.”

By Janine Weisman

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