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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Social cognition and interaction training (SCIT)
Treatment as usual (TAU)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Social Cognition, Group Therapy, Psychosocial Intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Participants will receive treatment as usual

Outcomes

Primary Outcome Measures

Face Emotion Identification Task (FEIT)
Face Emotion Discrimination Task (FEDT)
The Hinting Task
The Awareness of Social Inference Test (TASIT)
Ambiguous Intentions Hostility Questionnaire(AIHQ)

Secondary Outcome Measures

"Beads in the Jar" Task
Quality of Life Scale (QLS)
Positive and Negative Syndrome Scale (PANSS)
Social Skills Performance Assessment (SSPA)
Schizophrenia Cognition Rating Scale (SCoRS)
Overt Social Cognition: A Rating Scale (OSCARS)
Lecomte Self-Esteem Scale
Number of Hospital Admissions

Full Information

First Posted
January 15, 2008
Last Updated
March 28, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00601224
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Social Cognition, Group Therapy, Psychosocial Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive social cognition and interaction training plus treatment as usual
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Social cognition and interaction training (SCIT)
Intervention Description
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
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
Primary Outcome Measure Information:
Title
Face Emotion Identification Task (FEIT)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Face Emotion Discrimination Task (FEDT)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
The Hinting Task
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
The Awareness of Social Inference Test (TASIT)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Ambiguous Intentions Hostility Questionnaire(AIHQ)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Secondary Outcome Measure Information:
Title
"Beads in the Jar" Task
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Quality of Life Scale (QLS)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Social Skills Performance Assessment (SSPA)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Schizophrenia Cognition Rating Scale (SCoRS)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Overt Social Cognition: A Rating Scale (OSCARS)
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Lecomte Self-Esteem Scale
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up
Title
Number of Hospital Admissions
Time Frame
Measured at baseline, post-treatment, and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L. Penn, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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

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