Clinical trial NCT00601224: Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia
Official title: Social Cognition and Interaction Training for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Social Cognition
Group Therapy
Psychosocial Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-01-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Face Emotion Identification Task (FEIT)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Face Emotion Discrimination Task (FEDT)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: The Hinting Task
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: The Awareness of Social Inference Test (TASIT)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Ambiguous Intentions Hostility Questionnaire(AIHQ)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
Secondary outcomes:
measure: "Beads in the Jar" Task
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Quality of Life Scale (QLS)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Social Skills Performance Assessment (SSPA)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Schizophrenia Cognition Rating Scale (SCoRS)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Overt Social Cognition: A Rating Scale (OSCARS)
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Lecomte Self-Esteem Scale
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
measure: Number of Hospital Admissions
timeFrame: Measured at baseline, post-treatment, and 6-month follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David L. Penn, PhD
role: PRINCIPAL_INVESTIGATOR
References: