Mechanistic Interventions and Neuroscience of Dissociation

Обзор

The purpose of this study is to test the neurophysiological mechanisms of an intervention to reduce symptoms of dissociation in traumatized people. The intervention will be tested in dissociative traumatized people at two sites: Emory University and University of Pittsburgh. The researchers are interested in whether neural networks associated with attentional control and interoceptive awareness can be enhanced in this population. The researchers propose to evaluate whether different body-focused and non-body focused interventions can change these mechanisms.

Подробное описание

People exposed to chronic trauma face devastating effects to the brain and body. Chronically traumatized people become highly distressed when attending to emotional stimuli, which can lead to feelings of detachment from their bodies and environment. It is difficult to engage highly dissociative traumatized patients in trauma-focused treatment; however, these patients benefit from acquiring basic emotion regulation skills, including present-centeredness and body awareness. Various practices that involve present-centeredness and body awareness (including mindfulness-based interventions) have been shown to demonstrate short-term and long-term improvement in cognition, emotion regulation and clinical symptoms in dissociative people with trauma exposure.

In order to address this issue, the researchers will evaluate the effectiveness of interventions that engage present-centered awareness and/or body focus.

Вмешательства

• Устройство Vibration
  Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. There will be no explicit tasks or direction given in this intervention. Participants will experience smooth slowly varying breath-like vibration on their sternum. They will receive th
• Поведенческое Breath Focus
  Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. The participant will be asked to focus on their breathing during this intervention. They will receive their assigned intervention for approximately 18 minutes.
• Поведенческое No Distractions
  Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. Participants will engage in a period of no-screen time; during this time there will be no outside visual or auditory distractions. There will be no explicit tasks or direction given in

Первичные конечные точки

• Change in Clinician Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Mini International Neuropsychiatric Interview (MINI) Diagnosis of Psychiatric Disorders [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Multiscale Dissociation Inventory (MDI) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Kentucky Mindfulness Scale (KIMS) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Attentional Control Scale (ACS) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Difficulties in Emotion Regulation Scale (DERS) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in PTSD Symptom Checklist (PCL-5) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Change in Life Events Checklist Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]
• Change in Sense of Agency Rating Scale (SOARS) Score [Срок оценки: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention]

Критерии участия

Критерии включения

• experience of at least one Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criterion A trauma (assessed using the Life Events Checklist)
• a score of 7 or higher on the Multiscale Dissociation Inventory (MDI) depersonalization subscale
• willingness to participate in the study

Критерии исключения

• actively psychotic and cognitively compromised individuals (assessed using the Moderate-severe cognitive impairment screening tool (MoCA) will be excluded
• moderate or more severe substance dependence (assessed with the MINI)
• persons with imminent risk of physical violence to self or others

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Grady Hospital — Atlanta
• Western Psychiatric Institute and Clinic — Pittsburgh

Идентификаторы

NCT: NCT04670640 · STUDY00001840 · R01AT011267-01 · 2025P011607

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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