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Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2009
First Received: January 15, 2008   Last Updated: March 12, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00601224
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Behavioral: Social cognition and interaction training (SCIT)
Behavioral: Treatment as usual (TAU)
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Official Title: Social Cognition and Interaction Training for Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Face Emotion Identification Task (FEIT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Face Emotion Discrimination Task (FEDT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • The Hinting Task [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • The Awareness of Social Inference Test (TASIT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Ambiguous Intentions Hostility Questionnaire(AIHQ) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • "Beads in the Jar" Task [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Quality of Life Scale (QLS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Social Skills Performance Assessment (SSPA) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Overt Social Cognition: A Rating Scale (OSCARS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Lecomte Self-Esteem Scale [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ]
  • Number of Hospital Admissions [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: June 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive social cognition and interaction training plus treatment as usual
Behavioral: Social cognition and interaction training (SCIT)
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.
Behavioral: Treatment as usual (TAU)
TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
2: Active Comparator
Participants will receive treatment as usual
Behavioral: Treatment as usual (TAU)
TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.

Detailed Description:

Schizophrenia is a serious mental condition that affects approximately 1.1% of adults in the United States. People with schizophrenia experience reality perception impairments, which most commonly manifest as hallucinations, extreme paranoia, social withdrawal, and disordered thinking. Deficits in social functioning are a core feature of schizophrenia. In an effort to improve social functioning, there has been growing interest in identifying factors that underlie psychosocial impairments. One such identified factor has been neurocognition, but treatments that target solely cognitive processes do not always help overall social functioning. Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of SCIT versus treatment as usual (TAU) in helping people with schizophrenia improve their social cognition and social functioning.

Participation in this single-blind study will last 11 months. All potential participants will undergo initial screening, involving the completion of a few brief tasks testing social functioning. Eligible participants will then be randomly assigned to receive SCIT plus TAU or TAU alone. Participants assigned to receive SCIT will attend twenty 1-hour weekly group sessions over 5 months. During these sessions, participants will learn ways to manage emotions, work through problems, and integrate into social situations. Participants assigned to TAU alone will meet with their case managers and healthcare provider on an as-needed basis. All participants will undergo assessments of social cognition, social functioning, and psychotic symptoms prior to treatment, immediately post-treatment, and 6 months after treatment. Each assessment will last 3 hours and will include interviews, questionnaires, and a variety of tasks testing social skills. Researchers will also contact a family member or significant other about the participant's social functioning at the same three assessment times noted above.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601224

Contacts
Contact: Piper S. Meyer, PhD 919-843-5262 psmeyer@email.unc.edu

Locations
United States, North Carolina
University of North Carolina Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: David L. Penn, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: David L. Penn, PhD The University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: University of North Carolina at Chapel Hill ( David L. Penn, PhD )
Study ID Numbers: R34 MH080010, DATR A2-AISZ
Study First Received: January 15, 2008
Last Updated: March 12, 2009
ClinicalTrials.gov Identifier: NCT00601224     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Social Cognition
Group Therapy
Psychosocial Intervention

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009