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| ID | Type | Description | Link |
|---|---|---|---|
| 5R33MH110542 | U.S. NIH Grant/Contract | View source | |
| 1R61MH110542 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Florida State University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| Rutgers University |
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The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).
The Investigators developed a novel psychosocial intervention called "Cognitive Reappraisal Intervention for Suicide Prevention (CRISP)," which aims to improve cognitive reappraisal ability (i.e. the ability to modify the appraisal of a situation to alter its emotional significance) (target), and reduce suicide risk (outcome). The conceptual framework views suicidal ideation and behavior as failed attempts to regulate negative emotions and by improving cognitive reappraisal, an effective emotion regulation strategy, the investigators expect to reduce suicide risk. This theory is supported by studies showing that unsuccessful attempts to regulate negative emotions and decreased cognitive reappraisal are associated with increased suicidal ideation and behavior.
The R61 phase is a proof-of-principle phase and its goals are to optimize CRISP and test its engagement with cognitive reappraisal. Certified social workers will administer 12 weekly sessions of CRISP to 40 middle-aged and older adults (50-90 years old) after a suicide-related hospitalization. Research assistants, unaware of the study aims, will conduct assessments at study entry (hospital admission), discharge, 6 and 12 weeks post-discharge. Target engagement will be assessed with EEG assessments during a standard pictured-based stimuli and our novel cognitive reappraisal paradigm.
The R33 phase aims to provide further evidence of target engagement of the optimized CRISP in a larger sample, evaluate the relationship of cognitive reappraisal with suicide risk as measured with Columbia Suicide Severity Rating Scale (C-SSRS) and estimate implementation parameters for a large-scale clinical trial. A different sample of 90 middle-aged and older adults (using the same inclusion/exclusion criteria as for the R61 phase) will be randomized to CRISP or to Supportive Therapy (ST, a control treatment not designed to improve emotion regulation). Assessments will be conducted on admission, at discharge, and at 6, 12 and 24 weeks post-discharge. Primary aims are: 1) CRISP participants will show improvement in cognitive reappraisal ability from discharge to end of treatment; and 2) improvement in cognitive reappraisal ability will be associated with suicide risk over 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRISP (R33) | Experimental | Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
|
| Supportive Therapy (ST) (R33) | Active Comparator | Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
|
| CRISP (R61) | Experimental | Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Reappraisal Intervention for Suicide Prevention | Behavioral | Cognitive Reappraisal Intervention for Suicide Prevention, or CRISP, is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks. These values are the mean result of a composite measure (50% of each task) of μVoltage during the Autobiographical Affective Regulation Task (AART) and a standard picture-based emotion regulation task. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R33). | Baseline, 6, 12 |
| Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) | The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks at Baseline and Week 12. These values are the mean result of a composite measure (50% of each task) of a) a standardized picture-based emotion regulation task in parietal (Pz) site during 1600-2000ms and b) AART in parietal (Pz) site during 0-3000 ms. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R61). | Baseline - Week 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33) | The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-5, with lower numbers indicating less severity and higher numbers more severity. The outcome variable is scored with respect to the most severe type of ideation from the following Yes or No questions "Wish to be Dead," "Non-Specific Active Suicidal Thoughts," "Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act," "Active Suicidal Ideation with Some Intent to Act, without Specific Plan," and "Active Suicidal Ideation with Specific Plan and Intent." A response of "Yes" yields a score of 1 and a response of "No" yields a score of 0. The highest score a participant can receive is 5. If the answer to question 2 is "Yes" then questions 3, 4, and 5 are asked. Only if the questions 1 and 2 are recorded as "Yes' the outcome the Intensity of Ideation is completed. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Kiosses, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine | White Plains | New York | 10605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29395858 | Derived | Kiosses DN, Alexopoulos GS, Hajcak G, Apfeldorf W, Duberstein PR, Putrino D, Gross JJ. Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) for Middle-Aged and Older Adults Hospitalized for Suicidality. Am J Geriatr Psychiatry. 2018 Apr;26(4):494-503. doi: 10.1016/j.jagp.2017.11.009. Epub 2017 Dec 27. |
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De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
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Data will be available as per NIH's data sharing policy.
Access criteria is determined by NIH and can be requested by applying online.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRISP (R61) | Experimental: CRISP (R61) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| FG001 | CRISP (R33) | Experimental: CRISP (R33) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| FG002 | CRISP (ST) (R33) | Active Comparator: Supportive Therapy (ST) (R33) Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CRISP R61 |
|
| |||||||||||||||||||||
| CRISP R33 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CRISP (R61) | Experimental: CRISP (R61) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks. These values are the mean result of a composite measure (50% of each task) of μVoltage during the Autobiographical Affective Regulation Task (AART) and a standard picture-based emotion regulation task. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R33). | This is the analyses of the R33 phase of the study. | Posted | Mean | Standard Deviation | μVoltage | Baseline, 6, 12 |
|
CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
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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 | CRISP (R61) | Experimental: CRISP (R61) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Depressive Disorder | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Episode | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dimitris Kiosses | Weill Cornell Medicine | 914-997-4381 | dkiosses@med.cornell.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol | Aug 6, 2018 | Sep 12, 2025 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Intervention Manual | Jun 10, 2020 | Sep 12, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: CRISP R33 ICF | Nov 6, 2023 | Aug 1, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: CRISP R61 ICF | Aug 6, 2018 | Aug 1, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| D013405 | Suicide |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068356 | Self-Control |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
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|
|
| Supportive Therapy | Behavioral | ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors |
|
|
| Baseline - Week 12 |
| Dropped before therapy |
|
| NOT COMPLETED |
|
|
| BG001 | CRISP (R33) | Experimental: CRISP (R33) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| BG002 | CRISP (ST) (R33) | Active Comparator: Supportive Therapy (ST) (R33) Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | CRISP (R33) | Experimental: CRISP (R33) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. |
| OG002 | CRISP (ST) (R33) | Active Comparator: Supportive Therapy (ST) (R33) Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
|
|
| Primary | Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) | The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks at Baseline and Week 12. These values are the mean result of a composite measure (50% of each task) of a) a standardized picture-based emotion regulation task in parietal (Pz) site during 1600-2000ms and b) AART in parietal (Pz) site during 0-3000 ms. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R61). | Analyzed subjects for CRISP R61. Out of 35 participants, 12 participants' data were not used for this analysis: 5 dropped before starting therapy, 5 had adverse event, and 2 were lost to follow up. | Posted | Mean | Standard Deviation | μVoltage | Baseline - Week 12 |
|
|
|
| Other Pre-specified | Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33) | The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-5, with lower numbers indicating less severity and higher numbers more severity. The outcome variable is scored with respect to the most severe type of ideation from the following Yes or No questions "Wish to be Dead," "Non-Specific Active Suicidal Thoughts," "Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act," "Active Suicidal Ideation with Some Intent to Act, without Specific Plan," and "Active Suicidal Ideation with Specific Plan and Intent." A response of "Yes" yields a score of 1 and a response of "No" yields a score of 0. The highest score a participant can receive is 5. If the answer to question 2 is "Yes" then questions 3, 4, and 5 are asked. Only if the questions 1 and 2 are recorded as "Yes' the outcome the Intensity of Ideation is completed. | This analysis is for R33 participants only. R33 participants who did not complete Week 12 were excluded from analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 12 |
|
|
|
| 0 |
| 35 |
| 8 |
| 35 |
| 0 |
| 35 |
| EG001 | CRISP (R33) | Experimental: CRISP (R33) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. | 0 | 48 | 13 | 48 | 2 | 48 |
| EG002 | CRISP (ST) (R33) | Active Comparator: Supportive Therapy (ST) (R33) Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. | 0 | 24 | 4 | 24 | 1 | 24 |
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | Systematic Assessment |
|
| Ischemic Stroke | Nervous system disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Wound Infection | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D012919 |
| Social Behavior |
| Week 12 |
|
|