Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Delusional Disorder; Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Delusions; Schizophrenia, Paranoid
Study type: Interventional

Summary: 
      This study will assess the effectiveness of an experimental treatment intervention for
      adolescents and adults who have experienced their first episode of psychosis during the past
      two years.

      The DUP sub-study will collect pathways to care information that will be used to inform the
      development and pilot testing of strategies that aim to reduce DUP among individuals
      experiencing a first episode of psychosis.
    

Detailed description: 
      This study is part of the National Institute of Mental Health's Recovery After an Initial
      Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the
      trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the
      earliest stages of illness. This study, the RAISE Connection Program, is one of the two
      independent research studies that NIMH has funded to conduct the NIMH RAISE Project. The
      Connection Program is being supported in whole or in part with Federal funds from the
      American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health,
      Department of Health and Human Services. The Connection Program aims to to assess the
      effectiveness of a Team-based intervention for individuals with a first psychotic episode,
      observing outcomes over time for our study participants. When tracking outcomes, the
      Connection Program will make comparisons with what is known about the natural history of
      untreated first episode of psychosis as well as usual care outcomes from other experimental
      studies.

      This study is for people who have experienced symptoms such as hallucinations, unusual
      thoughts or beliefs, or disorganized thinking for the first time during the past two years.
      Without treatment, many people have a difficult time with these symptoms, which can be very
      upsetting and also make it hard to socialize, study, or work.

      People have different wishes and needs, and it is not clear what combination of treatments
      and services is best for any one person. There are many possible treatments and services,
      such as medications, talk therapy, case management, and school and job counseling. This study
      will adapt and evaluate the impact of a comprehensive and integrated treatment intervention
      for first episode psychosis to be delivered in real-world practice settings to promote
      symptomatic recovery, minimize disability, and maximize social, academic, and vocational
      functioning.

      Participation in this study will last up to 2 years. At the baseline visit, participants will
      be enrolled to receive the experimental intervention. During the study period, participants
      will take part in research interviews every three to six months for a total of 6 interviews.
      Each of these research interviews will take 1.5 to 3 hours to complete. Assessments of
      participants' health condition, overall function and illness severity, employment status,
      academic performance, and social functioning will be conducted during these research
      interviews. In addition to assessing functioning and illness severity, this study will also
      address substance abuse and utilization of healthcare services. Participants will also be
      measured for their height, weight and waist circumference. This portion of the study
      concluded in December 2013.

      The RAISE-DUP contract modification seeks additional information on the referral pathways
      that resulted in enrollment in the RAISE Connection Program from individuals who participated
      in RAISE Connection Program services and their family members. Information gathered through
      qualitative research interviews will be used to inform the development and pilot testing of
      outreach, education, and engagement intervention strategies, to serve the larger goal of
      reducing the duration of untreated psychosis among individuals experiencing a first episode
      of psychosis.
    

Intervention name(s): Multi-element, team-oriented treatment
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Delusional Disorder; Psychosis; First episode