Randomized
Controlled Trial of the Graduated Recovery Intervention
Program for Early Psychosis
PI:
David Penn , Ph.D. and Diana Perkins, M.D.
Sponsor:
NIMH
Contact
person: Liz Cook Phone:
843-3421 e-mail:
elizabeth_cook@med.unc.edu
Brief
Description: (include length of study)
The
purpose of this study is to implement a new manual-based
intervention for early psychosis, the Graduated Recovery
Intervention Program (GRIP), in the context of a small-scale
randomized controlled trial to evaluate its efficacy.
All participants (N = 50) will receive “treatment as usual”
for early psychosis (TAU; case management and medication
management), and half of the participants will also receive
GRIP. Participants can receive GRIP for up to 36 sessions
(nine months). Thus, this study will seek to determine
whether GRIP can add clinical utility above and beyond basic
services provided to all clients. The primary outcome
is social functioning, and secondary outcomes include symptoms,
attitudes toward treatment, substance use, and hospital
readmission rate. Potential moderators (e.g., duration
of untreated psychosis, premorbid functioning) and mediators
(e.g., therapeutic alliance) of treatment response will
also be identified. Participants will be clients at the
UNC Hospitals “Outreach and Support Intervention Services”
(OASIS) program for early psychosis, and individuals will
be assessed at baseline, mid-treatment, post-treatment,
and 3-month follow-up. Total study participation may last
up to one year.
Subject
Payment:
Up
to $165 if all study visits are completed ($15 for screening
and $50 for each of 3 visits)
Major
inclusion criteria:
Over
age 18, diagnosed with schizophrenia-spectrum disorder,
within first three years of treatment for psychosis, clinically
stable outpatient at UNC OASIS program
Major
exclusion criteria:
IQ
< 70; chronic psychotic disorder; organic brain disorder
Site
of study: UNC outpatient (OASIS Clinic)
Target
enrollment: 50
Date enrollment closes: Fall 2007
