Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PTSD Checklist (PCL-5)
研究概览
简要总结
This RCT investigates whether Cognitive Processing Therapy, a first line treatment for PTSD, can be enhanced by the use of the odor molecule Hexadecenal (HEX). HEX is secreted from body odor and has been shown to promotes psychological well-being and positive social interaction. For the active group Hex will be diffused in the treatment room during all treatment sessions. For the control group a vehicle placebo molecule will be diffused. Both therapists and patients will be blind to study condition.
详细描述
In this triple blind (patient, therapist, independent evaluator) RCT, 40 patients with PTSD receiving standard Cognitive Processing Therapy will be randomized in a 1:1 ratio to receive either odorless Hexadecanal molecules or odorless mineral oil molecules (Control) diffused in the treatment room at all therapy sessions. Inclusion criteria: age>18 years, PTSD diagnosis according to DSM-5-TR. Exclusion: Bipolar, psychotic, or neurological disorders, drug abuse, any parallel psychotherapy, anosmia. Primary outcome: pre-to-post treatment change in PTSD symptom severity measured by the PTSD check List for DSM-5 (PCL-5). Additional outcomes: Depression (PHQ-9), anxiety (GAD-7), Anger (DAR-5), therapeutic alliance (WAI-SF).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The randomization list is prepared in advance. Research assistants with no contact with the patients, therapists, or independent clinical assessors operate the odor dispensers according to the randomization schedule in the designated rooms where treatments take place.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PTSD according to DSM-5
- •Age 18 years and over
- •Eligible for CPT treatment at the National Center for Traumatic Stress and Resilience
排除标准
- •Bipolar disorder, psychosis, neurological disorders
- •Drug Addiction
- •Parallel psychotherapy
- •Congenital or acquired anosmia.
结局指标
主要结局
PTSD Checklist (PCL-5)
时间窗: 12-16 weeks
A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5
次要结局
- Patient Health Questionnaire - 9 (PHQ-9)(12-16 weeks)
- Generalized Anxiety Disorder -7 (GAD-7)(12-16 weeks)
- Dimensions of Anger Reactions - 5 (DAR-5)(12-16 weeks)
- Working Alliance Inventory Short Form (WAI-SF(12-16 weeks)
研究者
Yair Bar-Haim
Professor of Psychology and Neuroscience
Tel Aviv University