Viewing Study NCT02845700



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Last Modification Date: 2024-10-26 @ 12:06 PM
Study NCT ID: NCT02845700
Status: COMPLETED
Last Update Posted: 2019-01-14
First Post: 2016-07-06

Brief Title: Perceptual Retraining to Reduce Suicide Risk
Sponsor: Florida State University
Organization: Florida State University

Study Overview

Official Title: Perceptual Retraining to Reduce Suicide Risk
Status: COMPLETED
Status Verified Date: 2017-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRS
Brief Summary: The study will use a prospective design consisting of three phases The phases are

1 the development of the perceptual retraining treatment PRT
2 the evaluation of the treatments feasibility and acceptability and
3 an assessment of its efficacy

During the third phase a pilot study will be conducted in which participants will be randomly assigned to either PRT or a waitlist control group in order to assess efficacy Diagnostic information and eligibility criteria will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual DSM 4th ed SCID and the Clinician Administered PTSD Scale for DSM-5 CAPS-5
Detailed Description: This study will use clinical interviews self-report measures and behavioral assessments to evaluate the efficacy of the PRT protocol The study will recruit approximately 30 veterans The primary inclusionary criterion will be that participants must show some evidence of olfactory perceptual bias toward military-relevant stimuli eg burning rubber decay fuel Investigators are not requiring current suicidal ideation as an entry criterion because investigators believe that a fair percentage of veterans will have some suicidal ideationintent but making this an entry requirement will limit the investigators ability to recruit given the tight timeline for the study

The study will consist of the development and evaluation of a novel intervention The essential feature of this intervention is the use of a gradient of triggering smells eg burning rubber decay fuel etc to which participants will be systematically exposed in an effort to facilitate habituation to these odors The PRT protocol will be administered over two 1-hour sessions Participants will return 1 month after their final PRT protocol session to complete a battery of follow-up measures as well as the CAPS-5

The primary outcome measures of interest are olfactory perceptual bias as measured by the olfactory bias assessment suicidal ideation and behaviors as measured by the Beck Suicide Scale and Depressive Symptom Inventory- Suicidality Subscale and symptoms related to suicide such as anxiety and trauma as measured by the Beck Anxiety Inventory and PTSD Checklist for DSM-5 respectively

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None