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A Novel Cognitive Reappraisal Intervention for Suicide Prevention (CRISP)

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ClinicalTrials.gov Identifier: NCT03026127
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this project 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). Suicide rates in this group are alarmingly high, and reducing suicide rates in at-risk populations is a major NIMH priority.

Condition or disease Intervention/treatment
Suicide Prevention Behavioral: Cognitive Reappraisal Intervention for Suicide Prevention Behavioral: Supportive Therapy

Detailed Description:

The goal of this project 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). Suicide rates in this group are alarmingly high, and reducing suicide rates in at-risk populations is a major NIMH priority.

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 electrocortical measures (i.e. late positive potential, LPP) 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 (3 to 1) to CRISP (N=60) or to Supportive Therapy (ST, a control treatment not designed to improve emotion regulation) (N=30). 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Novel Cognitive Reappraisal Intervention for Suicide Prevention
Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: ST


Outcome Measures

Primary Outcome Measures :
  1. Change in Late Positive Potential (EEG, Electroencephalography) from Baseline to Week 12 [ Time Frame: Baseline (Hospital Discharge) to Week 12 ]
    We will measure the patient's cognitive reappraisal ability using late positive potential of EEG with AART, an Autobiographical Affective Regulation Task, and a standard picture-based emotion regulation task. We will have a composite measure of these two tasks as the primary study outcome.


Other Outcome Measures:
  1. Columbia Suicide Severity Rating Scale [ Time Frame: Week 24 ]
    Suicide severity scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years and older
  2. 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)
  3. 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."
  4. Patients with any degree of suicidal ideation at discharge (Columbia Suicide Severity Rating greater or equal to 0) will be included.
  5. We will also include patients on psychotropics and on after-care community psychotherapy.

Exclusion Criteria:

  1. 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.
  2. Cognitive Impairment: We will exclude participants with Mini Mental State Exam less than 24.
  3. 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.
  4. Aphasia, sensory problems, and/or inability to speak English.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026127


Contacts
Contact: Dimitris Kiosses, PhD 9149974381 dkiosses@med.cornell.edu
Contact: Laurie Evans, MS 9146829100 ext 2570 lad9011@med.cornell.edu

Locations
United States, New York
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine Recruiting
White Plains, New York, United States, 10605
Contact: Dimitris Kiosses, PhD    914-997-4381    dkiosses@med.cornell.edu   
Contact: Laurie Evans, MS    914-682-9100 ext 2570    lad9011@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Stanford University
Stony Brook University
Investigators
Principal Investigator: Dimitris Kiosses, PhD Weill Cornell Medicine
More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03026127     History of Changes
Other Study ID Numbers: 1603017115
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing plan of the NIMH.

Keywords provided by Weill Medical College of Cornell University:
Suicide
Middle-aged and Older Adults
Cognitive Reappraisal
Emotion Regulation

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms