Trial Outcomes & Findings for A Novel Cognitive Reappraisal Intervention for Suicide Prevention (NCT NCT03026127)

Last Updated: 2025-10-31

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

Baseline, 6, 12

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
CRISP R61 STARTED	35	0	0
CRISP R61 COMPLETED	23	0	0
CRISP R61 NOT COMPLETED	12	0	0
CRISP R33 STARTED	0	48	24
CRISP R33 COMPLETED	0	17	10
CRISP R33 NOT COMPLETED	0	31	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
CRISP R61 Adverse Event	5	0	0
CRISP R61 Lost to Follow-up	2	0	0
CRISP R61 Dropped before therapy	5	0	0
CRISP R33 Lost to Follow-up	0	5	4
CRISP R33 Adverse Event	0	9	5
CRISP R33 Withdrawal by Subject	0	9	1
CRISP R33 Lack of Efficacy	0	3	2
CRISP R33 Physician Decision	0	3	1
CRISP R33 Transportation	0	2	1

Baseline Characteristics

A Novel Cognitive Reappraisal Intervention for Suicide Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRISP (R61) n=35 Participants 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.	CRISP (R33) n=48 Participants 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.	CRISP (ST) (R33) n=24 Participants 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.	Total n=107 Participants Total of all reporting groups
Age, Continuous	60.80 years STANDARD_DEVIATION 8.47 • n=5 Participants	60.94 years STANDARD_DEVIATION 8.30 • n=7 Participants	60.63 years STANDARD_DEVIATION 9.05 • n=5 Participants	60.82 years STANDARD_DEVIATION 8.45 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	14 Participants n=5 Participants	66 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	22 Participants n=7 Participants	10 Participants n=5 Participants	41 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	46 Participants n=7 Participants	19 Participants n=5 Participants	94 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	40 Participants n=7 Participants	17 Participants n=5 Participants	84 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 6, 12

Population: This is the analyses of the R33 phase of the study.

Outcome measures

Outcome measures
Measure	CRISP (R33) n=48 Participants 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.	CRISP (ST) (R33) n=24 Participants 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.	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.
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) Baseline	5.61 μVoltage Standard Deviation 15.97	4.38 μVoltage Standard Deviation 9.20	—
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) Week 6	1.51 μVoltage Standard Deviation 9.10	0.48 μVoltage Standard Deviation 12.20	—
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) Week 12	2.09 μVoltage Standard Deviation 6.20	0.78 μVoltage Standard Deviation 5.22	—

PRIMARY outcome

Timeframe: Baseline - Week 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	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.	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.	CRISP (R61) n=23 Participants 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.
Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) Baseline	—	—	4.99 μVoltage Standard Deviation 4.45
Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) Week 12	—	—	3.10 μVoltage Standard Deviation 3.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline - Week 12

Population: This analysis is for R33 participants only. R33 participants who did not complete Week 12 were excluded from analysis.

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.

Outcome measures

Outcome measures
Measure	CRISP (R33) n=19 Participants 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.	CRISP (ST) (R33) n=12 Participants 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.	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.
Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33)	0.21 score on a scale Standard Deviation 0.98	-0.500 score on a scale Standard Deviation 1.45	—

Adverse Events

CRISP (R61)

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

CRISP (R33)

Serious events: 13 serious events

Other events: 2 other events

Deaths: 0 deaths

CRISP (ST) (R33)

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CRISP (R61) n=35 participants at risk 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.	CRISP (R33) n=48 participants at risk 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.	CRISP (ST) (R33) n=24 participants at risk 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.
Psychiatric disorders Major Depressive Disorder	11.4% 4/35 • Number of events 4 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	18.8% 9/48 • Number of events 10 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	16.7% 4/24 • Number of events 4 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Infections and infestations Upper Respiratory Tract Infection	2.9% 1/35 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/48 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Injury, poisoning and procedural complications Procedural Pain	5.7% 2/35 • Number of events 2 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	2.1% 1/48 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Renal and urinary disorders Renal Failure	2.9% 1/35 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/48 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Immune system disorders Anaphylactic Reaction	0.00% 0/35 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	2.1% 1/48 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Nervous system disorders Ischemic Stroke	0.00% 0/35 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	2.1% 1/48 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Metabolism and nutrition disorders Dehydration	0.00% 0/35 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	2.1% 1/48 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)

Other adverse events

Other adverse events
Measure	CRISP (R61) n=35 participants at risk 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.	CRISP (R33) n=48 participants at risk 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.	CRISP (ST) (R33) n=24 participants at risk 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.
Psychiatric disorders Psychiatric Episode	0.00% 0/35 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/48 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	4.2% 1/24 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Cardiac disorders Chest Pain	0.00% 0/35 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	2.1% 1/48 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)
Injury, poisoning and procedural complications Wound Infection	0.00% 0/35 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	2.1% 1/48 • Number of events 1 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)	0.00% 0/24 • CRISP R61 (12 Weeks) CRISP R33 (24 Weeks)

Additional Information

Dr. Dimitris Kiosses

Weill Cornell Medicine

Phone: 914-997-4381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place