Perceptual Retraining to Reduce Suicide Risk
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/16/2019 |
| Start Date: | September 2015 |
| End Date: | September 2016 |
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).
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).
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).
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).
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.
We found this trial at
2
sites
Tallahassee, Florida 32306
Principal Investigator: Wen Li, PhD
Phone: 850-645-1766
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New Orleans, Louisiana 70112
Principal Investigator: Laurel Franklin, PhD
Phone: 504-571-8352
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