Clinical trial NCT02845700: Perceptual Retraining to Reduce Suicide Risk
Official title: Perceptual Retraining to Reduce Suicide Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceptual Olfactory Bias
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Southeast Louisiana Veterans Health Care System
First posted: 2016-07-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

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 (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 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).

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.

Primary outcomes:
measure: Percent Change in Olfactory Perceptual Bias
timeFrame: Baseline, Week 1
Secondary outcomes:
measure: Change From Baseline in Mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 1 Month
timeFrame: Baseline, month 1
measure: Change in Suicidal Ideation Assessed Using the Depressive Symptom Inventory - Suicidality Subscale
timeFrame: Baseline, month 1
measure: Change in Beck Suicide Scale Scores From Baseline to 1 Month
timeFrame: Baseline, month 1
measure: Change in the Beck Anxiety Inventory-II From Baseline to 1 Month
timeFrame: Baseline, month 1
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
Study officials:
affiliation: Florida State University
name: Wen Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southeastern Louisiana Veterans Health Care System
name: Laurel Franklin, PhD
role: PRINCIPAL_INVESTIGATOR
References: