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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH101250 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBSST-CCT | Experimental | Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training |
|
| Goal-focused supportive contact | Active Comparator | Goal-focused supportive contact |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBSST-CCT | Behavioral |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Assessment Interview for Negative Symptoms (CAINS) | Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity. | baseline, 12.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery (MCCB) | Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance. | baseline, 12.5 weeks |
| UCSD Performance-based Skills Assessment-Brief (UPSA-B) |
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Inclusion Criteria:
MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Twamley, PhD | UCSD | Principal Investigator |
| Eric Granholm, PhD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34665853 | Derived | Granholm E, Twamley EW, Mahmood Z, Keller AV, Lykins HC, Parrish EM, Thomas ML, Perivoliotis D, Holden JL. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Schizophr Bull. 2022 Mar 1;48(2):359-370. doi: 10.1093/schbul/sbab126. |
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2 participants received the wrong diagnosis, and were withdrawn from the study; 7 participants had a CAINS score of ≤19, and were excluded from the study
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| ID | Title | Description |
|---|---|---|
| FG000 | CBSST-CCT | Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training CBSST-CCT |
| FG001 | Goal-focused Supportive Contact | Goal-focused supportive contact Goal focused supportive contact |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBSST-CCT | Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training CBSST-CCT |
| BG001 | Goal-focused Supportive Contact | Goal-focused supportive contact Goal focused supportive contact |
| 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 | Clinical Assessment Interview for Negative Symptoms (CAINS) | Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
10.5 months
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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 | CBSST-CCT | Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training CBSST-CCT |
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High participant dropout rate, leading to a smaller number of subjects analyzed than anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth W Twamley, PhD | Professor of Psychiatry, UC San Diego | 858-642-3848 | etwamley@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2018 | Nov 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Goal focused supportive contact |
| Behavioral |
|
Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance. |
| baseline, 12.5 weeks |
| Social Skills Performance Assessment (SSPA) | Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills. | baseline, 12.5 weeks |
| Specific Levels of Functioning Scale (SLOF) | Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning. | baseline, 12.5 weeks |
| Independent Living Skills Survey (ILSS) | Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills. | baseline, 12.5 weeks |
| Defeatist Performance Attitudes Scale (DPAS) | Change in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude. | baseline, 12.5 weeks |
| Scale for the Assessment of Negative Symptoms (SANS) | Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity. | baseline, 12.5 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | MATRICS Consensus Cognitive Battery (MCCB) | Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
|
|
| Secondary | UCSD Performance-based Skills Assessment-Brief (UPSA-B) | Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
|
|
| Secondary | Social Skills Performance Assessment (SSPA) | Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
|
|
| Secondary | Specific Levels of Functioning Scale (SLOF) | Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
|
|
| Secondary | Independent Living Skills Survey (ILSS) | Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
|
|
| Secondary | Defeatist Performance Attitudes Scale (DPAS) | Change in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
|
|
|
| Secondary | Scale for the Assessment of Negative Symptoms (SANS) | Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12.5 weeks |
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Goal-focused Supportive Contact | Goal-focused supportive contact Goal focused supportive contact | 0 | 29 | 0 | 29 | 0 | 29 |
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