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Perceptual Retraining to Reduce Suicide Risk (PRS)

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ClinicalTrials.gov Identifier: NCT02845700
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Collaborators:
United States Department of Defense
Southeast Louisiana Veterans Health Care System
Information provided by (Responsible Party):
Wen Li, Florida State University

Brief Summary:

The study will use a prospective design consisting of three phases. The phases are:

  1. the development of the sensory retraining treatment (SRT),
  2. the evaluation of the treatment's 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 SRT or a waitlist control group in order to assess efficacy. Diagnostic information and eligibility criteria will be assessed using the Structured Clinical Interview for DSM-IV (SCID) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).


Condition or disease Intervention/treatment Phase
Perceptual Olfactory Bias Behavioral: Perceptual Retraining Treatment Behavioral: Sham Neutral training Not Applicable

Detailed Description:

This study will use clinical interviews, self-report measures, and behavioral assessments to evaluate the efficacy of the SRT 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 (e.g., 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 ideation/intent 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 (e.g., burning rubber, decay, fuel, etc.), to which participants will be systematically exposed in an effort to facilitate habituation to these odors. The SRT protocol will be administered over two 1-hour sessions. Participants will return 1 month after their final SRT 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perceptual Retraining to Reduce Suicide Risk
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Sensory Retraining Treatment (SRT)

The retraining portion (SRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. During the retraining, participants will be given feedback to shift their bias away from the malodorous target stimuli. For example, in the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).

The retraining process will involve multiple ratings cycled through the malodors as well as other positive and neutral smells. Each training session will consist of 4 training blocks.

Behavioral: Perceptual Retraining Treatment
Perceptual retraining involves the systematic presentation of diluted malodors (i.e., odors perceived as threatening). For each individual, vials on either side of a pre-determined and ideographic detection threshold will be presented. During the retraining, participants will be given feedback to shift their bias away from the malodorous target stimuli. For example, in the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).

Placebo Comparator: Sham Neutral Training (SNT)
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
Behavioral: Sham Neutral training
Control condition using systematic presentation of diluted neutral-neutral odor pairs.




Primary Outcome Measures :
  1. Change in olfactory perceptual bias [ Time Frame: Baseline, Week 1 ]
    A participant's ability to detect an array of threatening malodor in neutral dilution gradients will be tested at baseline and after the second and final intervention session, approximately one week after the baseline appointment. Perceptual bias is calculated as the percentage of correct responses (i.e., yes or no to detecting the malodor) on an odor over 6 trials for each of the 8 odors, at 25% and 33% dilution (i.e., over 96 trials).


Secondary Outcome Measures :
  1. Change in PTSD symptoms assessed using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline, month 1 ]
    The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) will be administered at the baseline appointment and 1-month follow-up appointment to assess for changes in PTSD symptoms.

  2. Change in suicidal ideation assessed using the Depressive Symptom Inventory - Suicidality Subscale [ Time Frame: Baseline, month 1 ]
    The Depressive Symptom Inventory - Suicidality Subscale will be administered at the baseline appointment and 1-month follow-up appointment to assess for changes in thoughts related suicidal ideation and desire.

  3. Change in suicidal thoughts and behaviors assessed using the Beck Suicide Scale [ Time Frame: Baseline, month 1 ]
    The Beck Suicide Scale will be administered at the baseline appointment and 1-month follow-up appointment to assess for changes in thoughts and behaviors related to suicidal ideation, desire, and attempts

  4. Change in symptoms of anxious arousal assessed using the Beck Anxiety Inventory-II [ Time Frame: Baseline, month 1 ]
    The Beck Anxiety Inventory-II will be administered at the baseline appointment and 1-month follow-up appointment to assess for changes in commonly reported physical symptoms related to anxious arousal.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • evidence of olfactory perceptual bias toward military-relevant stimuli (e.g., burning rubber, decay, fuel).
  • military combat exposure in Operation Iraqi Freedom, Enduring Freedom, or New Dawn.
  • Age 18-60.

Exclusion Criteria:

  • Significant medical illness that compromises olfactory perception or tolerance (e.g., significant olfactory disease or dysfunction, cardiovascular disease, respiratory disorders, renal disease, epilepsy, stroke, and uncontrolled hypertension or migraines).
  • Evidence of imminent suicidal intent
  • Evidence of current or past psychotic-spectrum disorders, or uncontrolled bipolar disorder.
  • English speakers.

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): NCT02845700


Contacts
Contact: Joseph Boffa, MA (850) 645-1766 abhcfsu@psy.fsu.edu
Contact: Amanda M Raines, MS (504) 571-8352 amanda.raines@va.gov

Locations
United States, Florida
Florida State University Recruiting
Tallahassee, Florida, United States, 32306
Contact: Joseph W Boffa, MA    850-645-1766    abhcfsu@psy.fsu.edu   
Contact: Brittany Mathes, BS    (850) 645-1766    abhcfsu@psy.fsu.edu   
Principal Investigator: Wen Li, PhD         
United States, Louisiana
Southeast Louisiana Veterans Health Care System Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Amanda M Raines, MS    504-571-8352    amanda.raines@va.gov   
Contact: Laurel Franklin, PhD    (504) 571-8294    laurel.franklin@va.gov   
Principal Investigator: Laurel Franklin, PhD         
Sponsors and Collaborators
Florida State University
United States Department of Defense
Southeast Louisiana Veterans Health Care System
Investigators
Principal Investigator: Wen Li, PhD Florida State University
Principal Investigator: Laurel Franklin, PhD Southeastern Louisiana Veterans Health Care System

Responsible Party: Wen Li, Professor, Florida State University
ClinicalTrials.gov Identifier: NCT02845700     History of Changes
Other Study ID Numbers: A-16054.13a
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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