Perceptual Retraining to Reduce Suicide Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Percent Change in Olfactory Perceptual Bias
研究概览
简要总结
The study will use a prospective design consisting of three phases. The phases are:
- the development of the perceptual retraining treatment (PRT),
- the evaluation of the treatment's feasibility and acceptability, and
- 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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Perceptual Retraining Treatment (PRT)
The Perceptual Retraining Treatment will involve systematic presentation of diluted malodors. For each individual, vials on either side of their initial 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). Each training session will consist of 4 training blocks.
干预措施: Perceptual Retraining Treatment (Behavioral)
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 PRT. Following the one-month assessment, they will be given the option to complete the PRT.
干预措施: Sham Neutral training (Behavioral)
结局指标
主要结局
Percent Change in Olfactory Perceptual Bias
时间窗: 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 (one week after baseline). 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). Larger positive percentages indicate greater habituation to the malodor, and therefore a training effect toward reducing threat bias (i.e., a positive effect on intervention outcomes).
次要结局
- Change in Beck Suicide Scale Scores From Baseline to 1 Month(Baseline, month 1)
- Change From Baseline in Mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 1 Month(Baseline, month 1)
- Change in Suicidal Ideation Assessed Using the Depressive Symptom Inventory - Suicidality Subscale(Baseline, month 1)
- Change in the Beck Anxiety Inventory-II From Baseline to 1 Month(Baseline, month 1)
研究者
Wen Li
Professor
Florida State University