A Novel Cognitive Reappraisal Intervention for Suicide Prevention

Suicide Prevention Clinical Trial

— CRISP  

Official title:

A Novel Cognitive Reappraisal Intervention for Suicide Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03026127
• Other study ID #: 1603017115
• Secondary ID: 5R33MH1105421R61
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: Dimitris Kiosses, PhD
• Phone: 9149974381
• Email: dkiosses[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine	White Plains	New York

Sponsors (5)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Florida State University, National Institute of Mental Health (NIMH), Rutgers University, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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