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

March 28, 2013 updated by: David Penn, PhD, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 2
Participants will receive treatment as usual
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Face Emotion Identification Task (FEIT)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Face Emotion Discrimination Task (FEDT)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
The Hinting Task
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
The Awareness of Social Inference Test (TASIT)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Ambiguous Intentions Hostility Questionnaire(AIHQ)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
"Beads in the Jar" Task
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Quality of Life Scale (QLS)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Positive and Negative Syndrome Scale (PANSS)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Social Skills Performance Assessment (SSPA)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Schizophrenia Cognition Rating Scale (SCoRS)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Overt Social Cognition: A Rating Scale (OSCARS)
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Lecomte Self-Esteem Scale
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up
Number of Hospital Admissions
Time Frame: Measured at baseline, post-treatment, and 6-month follow-up
Measured at baseline, post-treatment, and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David L. Penn, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH080010 (U.S. NIH Grant/Contract)
  • DATR A2-AISZ (World Health Organization ICTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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