CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 67 enrolled
Drug / intervention
Cognitive enhancement therapy (CET) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00167362
NCT00167362Phase 3Completed

Rehabilitation, Brain Function and Early Schizophrenia

Beth Israel Deaconess Medical Center·interventional·Posted Sep 14, 2005·Updated Jan 10, 2017

In Brief

A Phase 3 clinical trial evaluating Cognitive enhancement therapy (CET) and Enriched supportive therapy (EST) for Schizophrenia. Completed, enrolled 67 participants across 1 site.

Detailed Summary

This study will determine the effectiveness of cognitive enhancement therapy (CET) in treating cognitive abnormalities in people experiencing the early stages of schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartAug 1, 2001
Primary CompletionAug 1, 2009
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 20.8 years ago

Interventions

Cognitive enhancement therapy (CET)behavioral

Using 80 to 100 hours of graduated exercises in computer assisted training, coupled with structured but unrehearsed in vivo social group interactions, CET tries to shift an early developmental reliance on effortful, serial and verbatim cognitive processing to a more gistful, less effortful and spontaneous abstraction of social themes. CET uses attention, memory and problem solving software from three exercises from Ben-Yishay's Orientation Remediation Module (the Attention Reaction Conditioner, Zero Accuracy Conditioner, and Time Estimates) that are graduated in difficulty and designed to enhance vigilance, selective attention, the ability to shift between auditory and visual modalities, and rapid decision-making.

Enriched supportive therapy (EST)behavioral

EST is the commonly recommended (Spaulding 1992) treatment for control and experimental subjects in psychosocial trials. EST is a two-staged treatment that requires weekly one-hour sessions in Phase 1 and biweekly sessions in Phase 2. Some practice principles (e.g., psychoeducation and relaxation training) are provided during the group exercises for CET patients, but individually for EST patients. No attempt is made to control for hours of contact between EST and CET, since offering three hours of supportive therapy to EST subjects is neither logistically feasible nor faithful to the goals and methods of supportive therapy. Further, neurobiological hypotheses related to treatment specificity would be best tested by clear differences in treatment intensity and content.