SchizophreniaNCT00587561
Efficacy of Social Cognition Training in Schizophrenia
A study testing Social Cognition Interaction Training and WLC in people with Schizophrenia, run by VA Connecticut Healthcare System at 2 sites in United States.
Trial summary
The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall 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 Interaction Training and WLC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- diagnosis of schizophrenia or schizoaffective disorder
- Age between 18 and 65
- minimum of 30 days since discharge from last hospitalization
- minimum of 30 days since last change in psychiatric medications
- no housing changes in the past 30 days
Who cannot join
- current diagnosis of alcohol or substance abuse/dependence
- history of brain trauma or neurological disease
- mental retardation or developmental disability
- auditory or visual impairment that would interfere with study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Connecticut Mental Health Center
New Haven, Connecticut, 06510
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy.
Objectives:
Read more
This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia.
Research Design and Methodology:
Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.
- Conditions
- Schizophrenia
- Being tested
- Social Cognition Interaction Training, WLC
- Keywords
- schizophrenia, social cognition, cognition, treatment, outcome
- 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 Interaction TrainingBehavioural
manualized group therapy
WLCBehavioural
wait-list control for 6 months, followed by the experimental group therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 Social Cognition Interaction Training | Experimental | Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training Receives: Behavioral: Social Cognition Interaction Training |
| 2 Wait List Control | Other | Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group Receives: Behavioral: WLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Cognitive Measures
change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement
Measured: 6 months - baseline
Secondary outcomes (1)
Basic Cognitive Measures
change score on Matrics Consensus Cognitive Battery (MCCB) 6 domain composite average t-score, t-score mean = 50 and SD=10, higher change scores indicate greater improvement; please note outcome is not a t-score itself but a change in t-score
Measured: 6 months - baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joanna Fiszdon, Ph.D., Principal investigator, VA Connecticut Heathcare System and Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587561
- Sponsor's protocol ID
- JMF0005
- Other IDs
- D4628W
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2007
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fiszdon JM, Dixon HD, Davidson CA, Roberts DL, Penn DL, Bell MD. Efficacy of social cognition and interaction training in outpatients with schizophrenia spectrum disorders: randomized controlled trial. Front Psychiatry. 2023 Aug 4;14:1217735. doi: 10.3389/fpsyt.2023.1217735. eCollection 2023.
PubMed 37599886
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Social Cognition Training in Schizophrenia
- ClinicalTrials.gov ID
- NCT00587561
- Acronym / sponsor ID
- JMF0005
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, social cognition, cognition, treatment, outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 3 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy.
Objectives:
This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia.
Research Design and Methodology:
Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Social Cognition Interaction Training | Experimental | Behavioral: Social Cognition Interaction TrainingWill receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training |
| 2 Wait List Control | Other | Behavioral: WLCWait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia or schizoaffective disorder
- Age between 18 and 65
- minimum of 30 days since discharge from last hospitalization
- minimum of 30 days since last change in psychiatric medications
- no housing changes in the past 30 days
Key exclusion criteria (4 listed)
- current diagnosis of alcohol or substance abuse/dependence
- history of brain trauma or neurological disease
- mental retardation or developmental disability
- auditory or visual impairment that would interfere with study procedures
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 Interaction Trainingmanualized group therapy | Behavioural | 1 Social Cognition Interaction Training |
| WLCwait-list control for 6 months, followed by the experimental group therapy | Behavioural | 2 Wait List Control |
Primary outcome
Social Cognitive Measures
Time frame: 6 months - baseline
change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement
1 secondary outcome
Basic Cognitive Measures
Time frame: 6 months - baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37599886Fiszdon JM, Dixon HD, Davidson CA, Roberts DL, Penn DL, Bell MD. Efficacy of social cognition and interaction training in outpatients with schizophrenia spectrum disorders: randomized controlled trial. Front Psychiatry. 2023 Aug 4;14:1217735. doi: 10.3389/fpsyt.2023.1217735. eCollection 2023.
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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.
Joanna Fiszdon, Ph.D. principal investigator
VA Connecticut Heathcare System and Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition Interaction Training and WLC in people with Schizophrenia, run by VA Connecticut Healthcare System at 2 sites 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 5 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Social Cognitive Measures (time frame: 6 months - baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00587561, which also lists 1 linked publication.
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 3 Oct 2025.