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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Penn, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00601224
First received: January 15, 2008
Last updated: March 28, 2013
Last verified: March 2013

January 15, 2008
March 28, 2013
June 2007
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00601224 on ClinicalTrials.gov Archive Site
  • "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 ]
Same as current
Not Provided
Not Provided
 
Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia
Social Cognition and Interaction Training for Schizophrenia

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • Experimental: 1
    Participants will receive social cognition and interaction training plus treatment as usual
    Interventions:
    • Behavioral: Social cognition and interaction training (SCIT)
    • Behavioral: Treatment as usual (TAU)
  • Active Comparator: 2
    Participants will receive treatment as usual
    Intervention: Behavioral: Treatment as usual (TAU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00601224
R34 MH080010, R34MH080010, DATR A2-AISZ
Yes
David Penn, PhD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Principal Investigator: David L. Penn, PhD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP