Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia

NCT00601224 | Completed Phase 1 DMC

• 2 other identifiers: R34MH080010DATR A2-AISZ
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the effectiveness of social cognition and interaction training, a manual-based group therapy program, in helping people with schizophrenia improve their social cognition and social functioning.

Conditions

Schizophrenia

Keywords

Social Cognition; Group Therapy; Psychosocial Intervention

Outcome Measures

Primary Outcomes (5)

• Face Emotion Identification Task (FEIT)

  Measured at baseline, post-treatment, and 6-month follow-up

• Face Emotion Discrimination Task (FEDT)

  Measured at baseline, post-treatment, and 6-month follow-up

• The Hinting Task

  Measured at baseline, post-treatment, and 6-month follow-up

• The Awareness of Social Inference Test (TASIT)

  Measured at baseline, post-treatment, and 6-month follow-up

• Ambiguous Intentions Hostility Questionnaire(AIHQ)

  Measured at baseline, post-treatment, and 6-month follow-up

Secondary Outcomes (8)

• "Beads in the Jar" Task

  Measured at baseline, post-treatment, and 6-month follow-up

• Quality of Life Scale (QLS)

  Measured at baseline, post-treatment, and 6-month follow-up

• Positive and Negative Syndrome Scale (PANSS)

  Measured at baseline, post-treatment, and 6-month follow-up

• Social Skills Performance Assessment (SSPA)

  Measured at baseline, post-treatment, and 6-month follow-up

• Schizophrenia Cognition Rating Scale (SCoRS)

  Measured at baseline, post-treatment, and 6-month follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive social cognition and interaction training plus treatment as usual

Behavioral: Social cognition and interaction training (SCIT); Behavioral: Treatment as usual (TAU)

2

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual (TAU)

Interventions

Social cognition and interaction training (SCIT) BEHAVIORAL

SCIT is a group-based treatment that has the goal of improving social cognition and social functioning for individuals with psychotic disorders. SCIT is composed of three phases: emotion training, figuring out situations, and integration. SCIT will be delivered by two therapists in 20 weekly sessions over 5 months.

1

Treatment as usual (TAU) BEHAVIORAL

TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Structured Interview of DSM-IV patient version (SCID-P)

You may not qualify if:

• Meets current criteria for substance dependence, based on the SCID-P
• Meets criteria for metal retardation (e.g., has an IQ of less than 80)
• History of brain injuries
• Difficulties interacting with others, based on ratings on items from the Social Functioning Scale that tap interactional skills

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David L. Penn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: June 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

US (1)