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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601224
First Posted: January 28, 2008
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Penn, PhD, University of North Carolina, Chapel Hill
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social Cognition and Interaction Training for Schizophrenia

Resource links provided by NLM:


Further study details as provided by David Penn, PhD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Face Emotion Identification Task (FEIT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Face Emotion Discrimination Task (FEDT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • The Hinting Task [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • The Awareness of Social Inference Test (TASIT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Ambiguous Intentions Hostility Questionnaire(AIHQ) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]

Secondary Outcome Measures:
  • "Beads in the Jar" Task [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Quality of Life Scale (QLS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Social Skills Performance Assessment (SSPA) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Overt Social Cognition: A Rating Scale (OSCARS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Lecomte Self-Esteem Scale [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]
  • Number of Hospital Admissions [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ]

Enrollment: 66
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601224


Locations
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David L. Penn, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Responsible Party: David Penn, PhD, Professor of Psychology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00601224     History of Changes
Other Study ID Numbers: R34MH080010 ( U.S. NIH Grant/Contract )
DATR A2-AISZ
First Submitted: January 15, 2008
First Posted: January 28, 2008
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by David Penn, PhD, University of North Carolina, Chapel Hill:
Social Cognition
Group Therapy
Psychosocial Intervention

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders