Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC)
研究概览
简要总结
This study will examine the effects of psychotherapy as treatment for PTSD, and specifically how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active mind-body comparison comparison therapy.
详细描述
This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active comparison therapy called Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will be randomly assigned to receive 8 weeks of group therapy in either MBCT or MRT treatments. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide saliva samples. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.
Due to COVID precautions, treatments shifted from in-person to remotely-delivered ("Zoom" video-conferencing) modality.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Statistician will not know the group assignment until blind is broken. Statistician randomizes the groups. Principal investigator will not know group assignment until blind is broken.
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for PTSD (with or without Major Depressive Disorder) or subsyndromal PTSD (has qualifying trauma, has intrusive and avoidant symptoms, and at least one negativity and one arousal symptom, and significant impairment); type of trauma shall be interpersonal violence, combat, and/or sexual assault, etc.
排除标准
- •Dissociative PTSD
- •Delayed-onset PTSD
- •Magnetic Resonance Imaging (MRI) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.)
- •Serious medical or neurologic conditions (e.g. stroke, seizures)
- •Suicide risk
- •Psychosis
- •Life history of schizophrenia
- •Life history of bipolar disorder
- •Current substance dependence
- •Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team
结局指标
主要结局
Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC)
时间窗: Intake (pre-therapy) and post therapy (approximately 9 - 10 weeks)
Posterior cingulate-seed functional connectivity with dorsolateral PFC index (PCC seed-dlPFC rsFC index) was measured using fMRI \[BOLD\] signal, a measure of brain regional blood flow used as a proxy for neural activity. BOLD signal while "resting" identified regions whose activity is correlated with a "seed" ROI within PCC. A whole-brain map of Pearson's (r) was transformed (Fisher r-to-Z) to a T-map. A beta from cluster in the hypothesized dlPFC region was extracted (as the "PCC seed-dlPFC rsFC index"). Fisher r-to-Z scores are not bounded to the -1 to +1 range, although practically rsFC scores fall in the -1.5 to +1.5 range. This index was used to test a pre-registered mechanistic hypothesis that MBCT would lead to an increase in PCC-dlPFC rsFC index, associated with increase in meta-cognitive emotional regulation. Increase in PCC-dlPFC rsFC index might theoretically be better; but this has not been clinically validated, and no clinically relevant thresholds for this index.
次要结局
- Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula)(pre-therapy and post therapy (approximately 9-10 weeks))
研究者
Anthony P King
Associate Professor of Psychiatry and Behaviroal Health
Ohio State University