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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH123609 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Suicide Prevention for psychosis (treatment group) | Experimental | Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. |
|
| Services as Usual (SAU; comparison group) | Active Comparator | Services as usual involve standard and current services that clients are eligible for receiving. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) | Behavioral | Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Calgary Depression Rating Scale (CDRS) | A scale to measure depression, higher scores indicate greater depression (range of 0-27) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
| Positive and Negative Syndrome Scale (PANSS) | A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
| Columbia Suicide Severity Rating Scale (C-SSRS) | A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Hopelessness Scale | A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
| Defeat Scale (D Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Upload to NIMH Data Archive
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group) | Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis |
| FG001 | Services as Usual (SAU; Comparison Group) | Services as usual involve standard and current services that clients are eligible for receiving. Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who met eligibility and were randomized to treatment or comparison groups
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group) | Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Calgary Depression Rating Scale (CDRS) | A scale to measure depression, higher scores indicate greater depression (range of 0-27) | Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history | Posted | Mean | Standard Deviation | score on a scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
|
between baseline assessment at 5 month assessment (follow up)
AEs are events that involve physical, social, economic, or psychological harm to subjects; or indicate the possibility of harm to others.
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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 | Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group) | Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lindsay Bornheimer | University of Michigan | 1 (734) 764-3309 | bornheim@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2024 | Feb 9, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2024 | Feb 9, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2023 | Oct 23, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D011618 | Psychotic Disorders |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| Services as Usual (SAU) | Behavioral | Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management) |
|
A scale to measure defeat, higher scores indicate greater defeat (range of 0-64)
| 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
| The Entrapment Scale | A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
| BG001 | Services as Usual (SAU; Comparison Group) | Services as usual involve standard and current services that clients are eligible for receiving. Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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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| Columbia Suicide Severity Rating Scale | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Services as Usual (SAU; Comparison Group) |
Services as usual involve standard and current services that clients are eligible for receiving. Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management) |
|
|
| Primary | Positive and Negative Syndrome Scale (PANSS) | A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210) | Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history | Posted | Mean | Standard Deviation | score on a scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
|
|
|
| Primary | Columbia Suicide Severity Rating Scale (C-SSRS) | A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5) | Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history | Posted | Mean | Standard Deviation | score on a scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
|
|
|
| Secondary | Beck Hopelessness Scale | A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20) | Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history | Posted | Mean | Standard Deviation | score on a scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
|
|
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| Secondary | Defeat Scale (D Scale) | A scale to measure defeat, higher scores indicate greater defeat (range of 0-64) | Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history | Posted | Mean | Standard Deviation | score on a scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
|
|
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| Secondary | The Entrapment Scale | A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64) | Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history | Posted | Mean | Standard Deviation | score on a scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). |
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| 0 |
| 25 |
| 2 |
| 25 |
| 0 |
| 25 |
| EG001 | Services as Usual (SAU; Comparison Group) | Services as usual involve standard and current services that clients are eligible for receiving. Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management) | 0 | 26 | 5 | 26 | 0 | 26 |
| Medical hospitalization | General disorders | Systematic Assessment |
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| D001523 | Mental Disorders |
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