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

NCT ID: NCT00601224

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-07-31

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Social cognition and interaction training (SCIT)

Intervention Type: 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)

Intervention Type: BEHAVIORAL

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

2

Participants will receive treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

David Penn, PhD

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David L. Penn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

R34MH080010

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A2-AISZ

Identifier Type: -

Identifier Source: secondary_id

R34MH080010

Identifier Type: NIH

Identifier Source: org_study_id

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