Brain Imaging, Cognitive Enhancement and Early Schizophrenia
Completed · Not applicable
Conditions studied: Schizophrenia, Schizoaffective Disorder
In brief
The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.
Key facts
- Study ID
- NCT01561859
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 102
- Starts
- 2012-06-01
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2021-02-26
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients will be included if they have:
- a diagnosis of schizophrenia or schizoaffective disorder verified by the SCID (in our data patients with both conditions respond similarly to CET);
- duration since first psychotic symptom of < 10 years;
- stable positive symptoms based on medical record review and SCID for at least 2 months;
- are currently maintained on and compliant with prescribed antipsychotic medication;
- age 18-55 years;
- significant social and cognitive disability based on the Cognitive Style and Social Cognition Eligibility Interview utilized in previous CET studies;
- current IQ >= 80; and
- the ability to read (sixth grade level or higher) and speak fluent English. This is a study of early course schizophrenia, not first-episode schizophrenia. A duration of illness since first psychotic symptom of < 10 years is adequate to define the early phase of the illness, particularly given that the average duration of untreated psychosis is a year or more. Eligibility criteria regarding IQ are justified from previous experience with CET indicating that individuals with severe mental incapacity are better served with less cognitively advanced programs.
You may not qualify if…
- In order to avoid confounders likely to affect cognition and limit response to cognitive rehabilitation, we will exclude those with:
- significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury);
- persistent suicidal or homicidal behavior;
- a recent (within the past 3 months) history of substance abuse or dependence; and
- any MRI contraindications such as ferromagnetic objects in the body.
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Massachusetts Institute of Technology — Cambridge, Massachusetts, United States
- Massachusetts General Hospital — Charlestown, Massachusetts, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Western Psychiatry Institute and Clinic — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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