Big Trial Tests Suicidality and Prevention in Real World
Abstract
The Collaboratory is a new approach to large-scale clinical trials intended to move interventions with major public health significance rapidly into clinical practice.
What works in a clinical trial and what works in the clinic can be two different things. Of necessity, clinical trials must test an intervention in a narrowly defined population to minimize confounders, but patients encountered in the real world are rarely packaged so neatly.
Now a new multisite trial seeks to enroll 19,500 patients to test suicide prevention programs out where patients live.
The online suicide prevention intervention was in part designed by people who had experienced suicidality or suicide attempts, said Rebecca Rossom, M.D., M.S.
“This is a very pragmatic clinical trial,” said investigator Rebecca Rossom, M.D., M.S., a clinical research associate at HealthPartners Institute for Education and Research in Bloomington, Minn., and an adjunct assistant professor of psychiatry at the University of Minnesota.
The project is one of the seven initial demonstration projects chosen by the National Institutes of Health (NIH) to be part of its Health Care Systems Research Collaboratory. The Collaboratory’s goal is “to revamp the nation’s clinical trials system to produce cost-effective, large-scale research studies and put the results of those studies into clinical practice as quickly as possible.”
The trial uses a simple screening procedure to recruit patients. “We are taking on all comers, as long as they score a 2 or 3 on the PHQ-9,” Rossom told Psychiatric News. “We want to see how these interventions work with real, live people.”
The trial will study patients at three major health systems: Kaiser Permanente, Group Health Cooperative in Washington state, and Minnesota’s HealthPartners.
The PHQ-9 asks about “thoughts that you would be better off dead or of hurting yourself in some way,” a general inquiry that can help clinicians identify people who are at elevated risk for suicide.
Collectively, the three systems generate 1.8 million PHQ-9s every year. Investigators will screen the reports every week to determine who would benefit from the interventions.
Patients are randomized before they are invited to participate, said Rossom. The control group will get treatment as usual. A second group will be invited join a risk-assessment and care-management program based on the Perfect Depression Care model developed at the Henry Ford Health System in Michigan. That includes outreach using secure messaging and encouraging follow-up care.
A third cohort will use a multimedia approach, an online training program called “Now Matters Now” to help patients develop skills to manage painful emotions and stressful situations; patients will be supported by outreach messages from an online coach. This intervention is based on the dialectical behavioral therapy developed by Marsha Linehan, Ph.D., a professor of psychology and an adjunct professor of psychiatry and behavioral sciences at the University of Washington.
“The online skills training method was designed with significant input from people with suicidal ideation,” said Rossom.
Researchers will track each patient for 18 months, and the trial is expected to last for five years. The primary outcome is time to a first suicide attempt.
From its pilot studies, the Group Health researchers came to view suicidality as an “enduring vulnerability rather than a short-term emergency.” Such risk seemed to continue for about a year after the first elevation of the PHQ-9. Risk declined after the first year—as long as patients were engaged in treatment.
A score of 2 or 3 (on a 0-to-3 scale of the PHQ-9) is a predictor of heightened risk for a suicide attempt. “If you scored zero, you had a 0.4 percent chance of a suicide attempt in the following year. And if you scored a 3, which means you’re thinking about suicide almost every day, your risk goes up to 4 percent,” said Rossom.
“We hope that we are able to test three questions,” said study leader Gregory Simon, M.D., M.P.H., a Group Health Research Institute senior investigator and a research professor in psychiatry and behavioral sciences at the University of Washington, in a statement. “Are we truly able to identify people who are at high risk? Do these programs help prevent suicide attempts? And will people accept these new programs?”
“This new trial is very exciting and has the potential to make a great difference in people’s lives [through] timely identification and appropriate treatment of mental disorders,” said Eve Moscicki, Sc.D., M.P.H., director of the Practice Research Network at the American Psychiatric Foundation. This will be a chance to gather the data to test that proposition, she said. ■
