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| ID | Type | Description | Link |
|---|---|---|---|
| D4628W |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Social Cognition Interaction Training | Experimental | Will receive 20-26 sessions of a manualized group treatment called 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Cognition Interaction Training | Behavioral | manualized group therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months - baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months - baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Fiszdon, Ph.D. | VA Connecticut Heathcare System and Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06510 | United States | ||
| VA Connecticut Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37599886 | Result | 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. |
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Our initial plan had been to recruit and enroll 48 participants. 67 volunteers were assessed for eligibility. Of those, 9 did not meet inclusion criteria and 7 declined to participate after learning more about the study. Our initial plan had been to randomized 48 volunteers however due to concerns about potential drop-out, we recruited and randomized 51 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual. |
| FG001 | Waitlist Control | Treatment as usual (0 - 6 months), then crossed-over to social cognition interaction training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 20-26 sessions of a manualized group treatment called social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual. |
| BG001 | Waitlist Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months - baseline |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group: Social Cognition Interaction Training | First period of Intervention Group, social cognition interaction training from 0 -6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Psychiatric disorders | psychiatric symptom exacerbation and hospitalization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanna Fiszdon | VA Connecticut Healthcare System | 2039325711 | 2231 | joanna.fiszdon@va.gov |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| WLC | Behavioral | wait-list control for 6 months, followed by the experimental group therapy |
|
| West Haven |
| Connecticut |
| 06516 |
| United States |
6 months of treatment as usual followed by Social Cognition Interaction Training
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months - baseline |
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| 0 |
| 25 |
| EG001 | Intervention Group: Treatment As Usual | Second period of Intervention Group, treatment as usual after 6 months. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Waitlist Control Group, Treatment As Usual | First period of Waitlist Control Group, treatment as usual from 0 - 6 months. | 0 | 26 | 1 | 26 | 0 | 26 |
| EG003 | Waitlist Control Group, Social Cognition Interaction Training | Second period of Waitlist Control Group, social cognition interaction training after 6 months. | 0 | 26 | 0 | 26 | 0 | 26 |
| hospitalization for suicidal ideation | Psychiatric disorders | hospitalization for symptom exacerbation with suicidal ideation |
|
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