The Effects of Sensory Motor Arousal Regulation Treatment (SMART) on Adults With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.
研究概览
简要总结
This study will investigate whether a movement and body-based treatment can benefit adults with Post-traumatic Stress Disorder (PTSD). The treatment is called Sensory Motor Arousal Regulation Treatment, or "SMART", and study participation involves 8 sessions of SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments.
详细描述
This study will investigate the use of SMART (Sensory Motor Arousal Regulation Treatment) with adults experiencing symptoms related to PTSD (Post-Traumatic Stress Disorder). In addition to the more well-known symptoms of PTSD (e.g., intrusive memories, avoidance, hypervigilance, and emotion dysregulation), chronic traumatic stress seems to overwhelm the brain's capacity to make sense of sensory information, affecting how traumatized people experience their own bodies and their surroundings. SMART builds on the sensory integration theory of intentionally engaging the senses via movement, touch, body awareness, and balance. The SMART protocol has been used effectively to treat children who have experienced psychological trauma, and the investigators will be investigating its use with adults. Participants enrolled in the study will be randomly assigned to one of two treatment conditions - i) SMART, or ii) wait list (i.e., delayed treatment). Study participation will involve 8, 1-hour sessions of SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments. For those assigned to the wait list condition, the same 8 SMART sessions will be offered after the 3-month follow-up assessment is complete, with no further assessment required.
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)
盲法说明
Assessors will be blinded to which treatment arm a participant was assigned.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, aged 18-65
- •A primary diagnosis of PTSD as determined by our pre-treatment assessment
- •Ability to provide informed consent
- •Fluency in written and spoken English (to be able to complete assessments)
- •Lives within 30km of London, ON
排除标准
- •any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)
- •history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident as assessed retrospectively by participant)
- •significant untreated medical illness
- •history of neurological or neurodevelopmental disorder
- •history of any pervasive developmental disorder
- •lifetime bipolar or psychotic disorder
- •alcohol/substance abuse or dependence within the last 3 months
- •extensive narcotic use (e.g., fentanyl, oxycodone, etc.)
- •anyone who would not be suitable for short-term treatment (as determined by our pre-treatment assessment)
- •suicide attempt in last 6 months
研究组 & 干预措施
Active SMART
Participants in the active SMART condition will complete 8 individual, 1-hour, weekly sessions of SMART with a therapist, as well as pre-treatment, post-treatment and 3-month follow-up assessments.
干预措施: SMART (Behavioral)
Wait List
Participants in the Wait List condition will receive no treatment for approximately 8 weeks, and they will be asked to complete pre-wait list, post-wait list and 3-month follow-up assessments. After all assessments have been completed, this group will be offered the same 8 individual, 1-hour, weekly sessions of SMART (no further assessments needed).
结局指标
主要结局
Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.
时间窗: 8 weeks
Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.
时间窗: 12 weeks
Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
次要结局
- Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.(8 weeks)
- Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.(12 weeks)
研究者
Ruth Lanius
MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's