CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
social cognitive training with in vivo augmentation +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01267019
NCT01267019N/ACompleted

Augmenting Social Cognitive Intervention for Veterans With Schizophrenia

VA Office of Research and Development·interventional·Posted Dec 24, 2010·Updated Mar 15, 2017

In Brief

A clinical study evaluating social cognitive training with in vivo augmentation, social cognitive training, and 1 other intervention for Psychosis. Completed, enrolled 153 participants across 1 site.

Detailed Summary

Veterans with schizophrenia and schizoaffective disorder experience high levels of disability and poor community outcome, and these poor functional outcomes constitute a major public health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally from a focus on symptom reduction to a focus on recovery and improving aspects of functioning. Needed improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it is necessary to find new treatments that address the key determinants of poor functional outcome, including social cognition. Both basic (non-social) cognition and social cognition are considered key determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic cognition includes the domains of: learning and memory, vigilance / attention, speed of processing, reasoning and problem solving, and working memory. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors of others. As part of the investigators' previous Merit grant, they have developed a training program for social cognition and are in the process of validating it. Initial results suggest that the program improves performance on measures of social cognition and functional capacity. In this study, the investigators will evaluate whether adding an in vivo component (training activities that occur in the community) to the current social cognition intervention facilitates generalization of training effects to community outcome and subjective satisfaction. Outcome measures of social cognition and functional capacity will be examined during the 12 week training program, and durability of benefits will be assessed at a 3-month follow up. Generalization to community functioning and subjective satisfaction will be assessed at the end of training and at the 3-month follow up. The investigators will enroll 105 patients across the 5 years of the study with random assignment to training group (social cognition intervention with in vivo exercises, social cognition intervention without in vivo exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point), completion of training (12 weeks), and the 3-month follow up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartFeb 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.5 years ago

Interventions

social cognitive training with in vivo augmentationbehavioral

24 sessions of social cognitive training plus 6 sessions of in vivo exercises

social cognitive trainingbehavioral

30 sessions of social cognitive training without in vivo exercises

non-social skills trainingbehavioral

30 sessions of skills training that has no specific social content