A Novel Cognitive Reappraisal Intervention for Suicide Prevention

NCT03026127 | Completed Results DMC

• 3 other identifiers: 16030171155R33MH1105421R61MH110542
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Suicide Prevention

Keywords

Suicide; Middle-aged and Older Adults; Cognitive Reappraisal; Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (1)

• Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33)

  Baseline - Week 12

Study Arms (3)

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.

Behavioral: Cognitive Reappraisal Intervention for Suicide Prevention

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.

Behavioral: Supportive Therapy

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.

Behavioral: Cognitive Reappraisal Intervention for Suicide Prevention

Interventions

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.

Also known as: CRISP

CRISP (R33); CRISP (R61)

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

Also known as: ST

Supportive Therapy (ST) (R33)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older

You may not qualify if:

• Recent hospitalization for suicidal ideation or suicide attempt. At hospital admission, Columbia Suicide Severity Rating Scale greater or equal to 3, "Active Suicidal Ideation with any methods or a suicide attempt."
• Patients with any degree of suicidal ideation at discharge (Columbia Suicide Severity Rating greater or equal to 0) will be included.
• Patients who are on psychotropics and on after-care community psychotherapy will also be included.
• History or current diagnosis of Psychotic Disorders; Current Diagnosis of Bipolar I or Bipolar II, with current episode hypomanic, manic or mixed; Diagnosis of Dementia.
• Cognitive Impairment: Mini Mental State Exam (MMSE) \< 24.
• Acute or severe medical illness (i.e. delirium; decompensated cardiac, liver, or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry.
• Aphasia, sensory problems, and/or inability to speak English.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Stanford University: collaborator
• Florida State University: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Rutgers University: collaborator

Study Sites (1)

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

White Plains, New York, 10605, United States

Location

Related Publications (1)

• 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.

  PMID: 29395858 DERIVED

MeSH Terms

Conditions

Suicide Prevention; Suicide; Emotional Regulation

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Dimitris Kiosses
• Organization: Weill Cornell Medicine

dkiosses@med.cornell.edu

914-997-4381

Study Officials

• Dimitris Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 20, 2017
• Study Start: March 28, 2017
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available as per NIH's data sharing policy.
• Access Criteria: Access criteria is determined by NIH and can be requested by applying online.

Locations

US (1)