A Novel Cognitive Reappraisal Intervention for Suicide Prevention (CRISP)

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).

Study Overview

• Status: Recruiting
• Conditions: Suicide Prevention
• Intervention / Treatment: Behavioral: Cognitive Reappraisal Intervention for Suicide Prevention; Behavioral: Supportive Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimitris Kiosses, PhD; Phone Number: 9149974381; Email: dkiosses@med.cornell.edu
• Study Contact Backup: Name: Laurie Evans, MS; Phone Number: 1012570 9146829100; Email: lad9011@med.cornell.edu

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Recruiting
      • Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
      • Contact: Dimitris Kiosses, PhD; Phone Number: 914-997-4381; Email: dkiosses@med.cornell.edu
      • Contact: Laurie Evans, MS; Phone Number: 1012570 914-682-9100; Email: lad9011@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 50 years and older
• Diagnosis (based on SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 depression or anxiety diagnosis, including major depressive disorder, bipolar depression, depressive disorder Not Elsewhere Classified, anxiety disorder Not Elsewhere Classified, adjustment disorder with anxiety and depressed mood (but without any of the diagnoses shown under Exclusion Criteria)
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRISP; 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; 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.; Other Names: CRISP
Active Comparator: Supportive Therapy (ST); 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; 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; Other Names: ST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Regulation, as measured by the Electroencephalogram (EEG), Autobiographical Affective Regulation Task (AART), and a standard picture-based emotion regulation task.	A composite measure of the above tasks with the EEG will be analyzed to assess the patient's cognitive reappraisal ability.	Baseline, 6, 12, and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Suicide Severity, as measured by the Columbia Suicide Severity Rating Scale (CSSR-S)	The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-10, with lower numbers indicating less severity and higher numbers more severity.	Baseline, Weeks 1-24

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH); Stanford University; Florida State University; Rutgers University
• Investigators: Principal Investigator: Dimitris Kiosses, PhD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimated): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Suicide; Emotion Regulation; Middle-aged and Older Adults; Cognitive Reappraisal
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide Prevention
• Other Study ID Numbers: 1603017115; 5R33MH110542 (U.S. NIH Grant/Contract); 1R61MH110542 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available as per NIH's data sharing policy.
• IPD Sharing Access Criteria: Access criteria is determined by NIH and can be requested by applying online.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No