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A Novel Cognitive Reappraisal Intervention for Suicide Prevention (CRISP)

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ClinicalTrials.gov Identifier: NCT03026127
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : January 20, 2017
Last Update Posted : December 24, 2020
Sponsor:
Collaborators:
Stanford University
Florida State University
National Institute of Mental Health (NIMH)
Rutgers University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE January 20, 2017
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE March 28, 2017
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2020)
Emotion Regulation, as measured by the Electroencephalogram (EEG), Autobiographical Affective Regulation Task (AART), and a standard picture-based emotion regulation task. [ Time Frame: Baseline, 6, 12, and 24 weeks ]
A composite measure of the above tasks with the EEG will be analyzed to assess the patient's cognitive reappraisal ability.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
Change in Late Positive Potential (EEG) from Baseline to Week 12 [ Time Frame: Baseline (Hospital Discharge) to Week 12 ]
We will examine change in LPP for two EEG tasks: an autobiographical cognitive reappraisal task and a standardized pictured-based reappraisal task.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 22, 2020)
Change in Suicide Severity, as measured by the Columbia Suicide Severity Rating Scale (CSSR-S) [ Time Frame: Baseline, Weeks 1-24 ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: January 17, 2017)
Columbia Suicide Severity Rating Scale [ Time Frame: Week 24 ]
Suicide severity scale
 
Descriptive Information
Brief Title  ICMJE A Novel Cognitive Reappraisal Intervention for Suicide Prevention
Official Title  ICMJE A Novel Cognitive Reappraisal Intervention for Suicide Prevention
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Suicide Prevention
Intervention  ICMJE
  • 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 Name: CRISP
  • 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 Name: ST
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive Reappraisal Intervention for Suicide Prevention
  • 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.
    Intervention: Behavioral: Supportive Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2017)
40
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03026127
Other Study ID Numbers  ICMJE 1603017115
5R33MH110542 ( U.S. NIH Grant/Contract )
1R61MH110542 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
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.
URL: https://nda.nih.gov/
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE
  • Stanford University
  • Florida State University
  • National Institute of Mental Health (NIMH)
  • Rutgers University
Investigators  ICMJE
Principal Investigator: Dimitris Kiosses, PhD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP