Social Cognition Intervention

NCT01267019 | Completed Results DMC

• 1 other identifier: MHBB-004-10S
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis

Keywords

social cognition; training intervention

Outcome Measures

Primary Outcomes (1)

• Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)

  A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

  baseline, 6 weeks, 12 weeks, and 3 months.

Secondary Outcomes (2)

• The Awareness of Social Inference Test (TASIT)

  baseline, 6 weeks, 12 weeks, and 3 months.

• Profile of Nonverbal Sensitivity (PONS)

  baseline, 6 weeks, 12 weeks, and 3 months.

Study Arms (3)

Arm 1: vivo augmentation

EXPERIMENTAL

social cognitive training with in vivo augmentation

Behavioral: social cognitive training with in vivo augmentation

Arm 2: social cognitive

ACTIVE COMPARATOR

social cognitive training

Behavioral: social cognitive training

Arm 3: non-social skills

ACTIVE COMPARATOR

non-social skills training

Behavioral: non-social skills training

Interventions

social cognitive training with in vivo augmentation BEHAVIORAL

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

Arm 1: vivo augmentation

social cognitive training BEHAVIORAL

30 sessions of social cognitive training without in vivo exercises

Arm 2: social cognitive

non-social skills training BEHAVIORAL

30 sessions of skills training that has no specific social content

Arm 3: non-social skills

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified (NOS) according to Diagnosis and Statistical Manual (DSM-IV) criteria. In addition, the subjects will meet the following criteria:
• Between 18 and 60 years of age
• Estimated premorbid intelligence quota \> 70 (based on reading ability)
• Understand spoken English sufficiently to comprehend testing procedures
• Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 4 weeks prior to enrollment, and none anticipated for the 3 months of participation)
• In sufficient health to be able to walk outdoors unaided for at least 15 minutes.

You may not qualify if:

• No clinically significant neurological disease as determined by medical history
• No history of serious head injury (e.g., loss of consciousness longer than 1 hour)
• No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
• No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing based on urine toxicology screen and saliva alcohol test strip. Subjects who test positive will not be disqualified but instead will be asked to return for testing on a different day. However, subjects who test positive on 3 consecutive occasions will be disqualified from the study.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (1)

• Horan WP, Dolinsky M, Lee J, Kern RS, Hellemann G, Sugar CA, Glynn SM, Green MF. Social Cognitive Skills Training for Psychosis With Community-Based Training Exercises: A Randomized Controlled Trial. Schizophr Bull. 2018 Oct 17;44(6):1254-1266. doi: 10.1093/schbul/sbx167.

  PMID: 29300973 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Michael F. Green, PhD
• Organization: VA Greater Los Angeles, VISN 22 MIRECC

mgreen@ucla.edu

(310) 268-3376

Study Officials

• Michael F Green, PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Locations

US (1)