{"id":46175,"date":"2014-05-14T08:00:20","date_gmt":"2014-05-14T12:00:20","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=46175"},"modified":"2014-05-14T08:11:45","modified_gmt":"2014-05-14T12:11:45","slug":"where-did-it-go-2","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/05\/14\/where-did-it-go-2\/","title":{"rendered":"where’s the beef?…"},"content":{"rendered":"\n

I really have a distaste for grant applications. I did some when I was an NIH Fellow in the bronze age and much later wrote periodic training grants. I get it<\/em> why one has to fill out all that stuff and look endlessly at the endless guidelines, but getting it<\/em> doesn’t erase the tedium of doing it<\/em>. I am discovering that reading such things is an equally odious task, having tried yesterday to make some sense out of the NIMH RAISE<\/em> Studies I mentioned earlier [a fabrication?…<\/a>]. While I’m at it, I apologize for the disjointedness of that last post. I started out with something in mind, but every time I looked something up, some new confusion reared its head. So the post wandered as I wandered from place to place trying to figure things out. This post is a second look at the material from that post.<\/p>\n

First off, I declare that I’m a supporter of both the efforts to identify people who are going to have psychosis in advance, though I question whether the existing methods being proposed are on the right track. And I also believe that early intense intervention in FSE [First Schizophrenic Episode] is an imperative. So my interest in the RAISE<\/em> Programs isn’t antagonistic, I just want to be sure that what’s being proposed is rational and likely to get us somewhere useful. So first, here is what I could find out about the grants:<\/p>\n

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2009, A Remarkable Year For NIMH<\/a><\/div>\n
NIMH Director’s blog<\/font><\/strong><\/div>\n
By Thomas Insel<\/div>\n
December 29, 2009<\/div>\n

From the extraordinary funding opportunities presented by the passage of the American Recovery and Reinvestment Act of 2009 [Recovery Act] to significant new investments in research and resource infrastructure — this has been a remarkable year for our Institute. I would like to reflect with you on how the work of 2009 has prepared us for the year ahead…<\/p>\n

Finally, I would like to highlight a research project launched this year that seeks to fundamentally change the way schizophrenia is treated: the Recovery After an Initial Schizophrenia Episode [RAISE<\/em>] project. The RAISE<\/em> project, which is also supported through Recovery Act funds, will develop and test innovative and coordinated intervention approaches in the early stages of the illness when symptoms may be most responsive to treatment. The study is designed to alter the long-term disability that can result from schizophrenia and help ensure that people with the disease can lead productive, independent lives. Importantly, the interventions being tested will be designed from the outset to be readily adopted in real-world health care settings and quickly put into practice.<\/div>\n<\/blockquote>\n
and here are the grants:<\/div>\n


[reformatted to fit]<\/sup><\/p>\n

OD stands for Office of the Director<\/em>, in this case I presume that the Director is allocating the funds from the American Recovery and Reinvestment Act<\/a> [ARRA]. An Aside<\/u>: This was the stimulus money after the Great Recession of 2008, I can’t resist showing their prediction graph from that time with what actually happened added [in red].<\/em><\/p>\n

<\/p>\n

So with the ARRA windfall, Dr. Insel funded two RAISE<\/em> [Recovery After an Initial Schizophrenia Episode] grants: RAISE Connection<\/em> [271200900020C-1-0-1<\/a>] and RAISE ETP<\/em> [271200900019C-0-0-1<\/a>]. Dr. Jeffrey Lieberman was Principle Investigator on RAISE Connection<\/em> – a two site effort looking to recruit >370 subjects. It looks as if they planned to have two treatment arms assigned randomly at both sites. Dr. John Kane [1<\/a>][2<\/a>] was the Principle Investigator on RAISE ETP<\/em> with 33 sites with a projected enrollment of >400 also with two arms, but each site was assigned to a specific arm. While the NIMH grant description for both was the same, the clinicaltrials.gov descriptions differed and they followed a remarkably different revision history.<\/p>\n

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And these are the two studies that were implemented from these grants: <\/p>\n

RAISE Connection:<\/font><\/strong> <\/em>Clinical Trial NCT01216891<\/a> was registered on October 4, 2010 with two arms<\/a>:<\/div>\n
    <\/p>\n
  1. \n
    Behavioral: Multi-element, team-oriented treatment<\/font><\/div>\n
    Arm Label: Team-based treatment:<\/font><\/div>\n
    Participants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment.<\/div>\n<\/li>\n
  2. \n
    Behavioral: Connections to community-based treatment and services <\/font><\/div>\n
    Arm Label: Facilitated community-based treatment:<\/font><\/div>\n
    A care specialist will work with participants to identify and link to treatment and service options that are available in the community. These options can include finding a therapist, obtaining ongoing medication treatment to address symptoms, joining a support group, and getting a job coach.<\/div>\n<\/li>\n

    <\/span><\/ol>\n

    It was logged as recruiting on 01\/14\/2011<\/a>, then recorded as Active, not recruiting on 02\/18\/2011<\/a>. Then on 06\/22\/2011<\/a> there were a number of changes:<\/div>\n