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Completed

NCT Number: NCT00601224

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Treatment as Usual (TAU)

Behavioral

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

Primary outcomes

  1. Face Emotion Identification Task (FEIT)

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

  2. Face Emotion Discrimination Task (FEDT)

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

  3. The Hinting Task

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

  4. The Awareness of Social Inference Test (TASIT)

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

  5. Ambiguous Intentions Hostility Questionnaire(AIHQ)

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

Secondary outcomes

  1. "Beads in the Jar" Task

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

  2. Quality of Life Scale (QLS)

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

  3. Positive and Negative Syndrome Scale (PANSS)

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

  4. Social Skills Performance Assessment (SSPA)

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

  5. Schizophrenia Cognition Rating Scale (SCoRS)

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

  6. Overt Social Cognition: A Rating Scale (OSCARS)

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

  7. Lecomte Self-Esteem Scale

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

  8. Number of Hospital Admissions

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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Social Cognition and Interaction Training for Schizophrenia

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 28, 2008
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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