N/A
N=13
Perceptual Retraining to Reduce Suicide Risk
Perceptual Olfactory Bias
Bottom Line
View on ClinicalTrials.gov: NCT02845700 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Percent Change in Olfactory Perceptual Bias — 21.33; -5 Percent of correctly identified odors — p=.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Perceptual Retraining Treatment (Behavioral); Sham Neutral training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Florida State University
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Olfactory Perceptual Bias |
21.33; -5 | .08 |
| SECONDARY Change From Baseline in Mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 1 Month |
-16.00; 2.00 | .39 |
| SECONDARY Change in Suicidal Ideation Assessed Using the Depressive Symptom Inventory - Suicidality Subscale |
0; 0 | — |
| SECONDARY Change in Beck Suicide Scale Scores From Baseline to 1 Month |
0; 0 | — |
| SECONDARY Change in the Beck Anxiety Inventory-II From Baseline to 1 Month |
-3.50; -1.75 | .54 |
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 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 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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02845700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.