SchizophreniaPhase 1NCT00601224
Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia
A Phase 1 study testing Social cognition and interaction training (SCIT) and Treatment as usual (TAU) in people with Schizophrenia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social cognition and interaction training (SCIT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Structured Interview of DSM-IV patient version (SCID-P)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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
- Being tested
- Social cognition and interaction training (SCIT), Treatment as usual (TAU)
- Keywords
- Social Cognition, Group Therapy, Psychosocial Intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social cognition and interaction training (SCIT)Behavioural
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)Behavioural
TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive social cognition and interaction training plus treatment as usual Receives: Behavioral: Social cognition and interaction training (SCIT); Behavioral: Treatment as usual (TAU) |
| 2 | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face Emotion Identification Task (FEIT)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Face Emotion Discrimination Task (FEDT)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
The Hinting Task
Measured: Measured at baseline, post-treatment, and 6-month follow-up
The Awareness of Social Inference Test (TASIT)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Ambiguous Intentions Hostility Questionnaire(AIHQ)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Secondary outcomes (8)
"Beads in the Jar" Task
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Quality of Life Scale (QLS)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Positive and Negative Syndrome Scale (PANSS)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Social Skills Performance Assessment (SSPA)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Schizophrenia Cognition Rating Scale (SCoRS)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Overt Social Cognition: A Rating Scale (OSCARS)
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Lecomte Self-Esteem Scale
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Number of Hospital Admissions
Measured: Measured at baseline, post-treatment, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Penn, PhD, University of North Carolina, Chapel Hill
- Investigators
- David L. Penn, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601224
- Sponsor's protocol ID
- R34MH080010
- Other IDs
- R34MH080010, DATR A2-AISZ
- Status last verified
- Mar 2013
- First submitted
- 15 Jan 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition and Interaction Training for Schizophrenia
- ClinicalTrials.gov ID
- NCT00601224
- Acronym / sponsor ID
- R34MH080010
- Conditions
- Schizophrenia
- Keywords
- Social Cognition, Group Therapy, Psychosocial Intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Social cognition and interaction training (SCIT), Behavioral: Treatment as usual (TAU)Participants will receive social cognition and interaction training plus treatment as usual |
| 2 | Active comparator | Behavioral: Treatment as usual (TAU)Participants will receive treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Structured Interview of DSM-IV patient version (SCID-P)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 |
| Treatment as usual (TAU)TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis. | Behavioural | 1, 2 |
Primary outcome
Face Emotion Identification Task (FEIT)
Time frame: 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
The Hinting Task
Time frame: 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
Ambiguous Intentions Hostility Questionnaire(AIHQ)
Time frame: Measured at baseline, post-treatment, and 6-month follow-up
8 secondary outcomes
"Beads in the Jar" Task
Time frame: 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
Positive and Negative Syndrome Scale (PANSS)
Time frame: 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
Schizophrenia Cognition Rating Scale (SCoRS)
Time frame: 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
Lecomte Self-Esteem Scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Penn, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Social cognition and interaction training (SCIT) and Treatment as usual (TAU) in people with Schizophrenia, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face Emotion Identification Task (FEIT) (time frame: Measured at baseline, post-treatment, and 6-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.