Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical measures- PSTD symptoms
研究概览
简要总结
Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in our lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD among women with a history of childhood sexual abuse (CSA).
详细描述
Pretreatment phase- All participants will undergo clinician evaluation, self-report measures and emotional regulation tasks in TASMC. In addition, participants will undergo a functional and structural MRI to characterize brain network responses associated with emotional arousal and regulation.
Participants will be randomized to one of two arms: (1) NF-EFP group and treatment as usual at out-patient clinic (TAU) or (2) TAU (without EFP-NF). If participant has a steady menstrual cycle she will be randomized to one of three arms: (1) NF group administered during low estrogen phase (and maintain TAU); (2) NF group administered during high estrogen phase (and maintain TAU) or (3) TAU (without EFP-NF).
Treatment phase (10 weeks) EFP-NF training, twice a week for a total of 10 sessions. For participants with steady menstrual phase treatment will be administered NF during designated-estrogen phases (high or low).
Treatment as usual: Participants will obtain their regular treatment regimen (pharmacological and psychological) and meet with a psychologist/psychiatrist following the common practice in the clinic.
NF-EFP sessions: For the duration of each NF-EFP session the participant will be seated comfortably in front of a computer screen. A staff member will explain the goal of the meeting to the participant, present the equipment to be used and describe the course of the meeting. The EEG-NF practice will consist of four-minute segments repeated for up to 30 minutes. During each practice segment the participant will be asked to modify visual media that provides feedback on the degree of successful brain training. The duration of one session is approximately 45 minutes.
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, Investigator, Outcomes Assessor)
盲法说明
Participant is aware of treatment group (NF or TAU) Participant is unaware of allocation to treatment estrogen phases (high or low) Investigator and outcome assessor are unaware of group allocation
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of age (18-62) :
- •Treated at Clinic for Sexual Assault with stable symptoms.
- •Fulfill screening criteria of DSM-V for PTSD. -
排除标准
- •Fulfill screening criteria of DSM-V for psychosis.
- •Substance dependence or abuse other than nicotine.
- •Diagnosis of a neurodegenerative disease.
- •Acute illness that could be worsen by the treatment. -
研究组 & 干预措施
EFP-NF (participants without steady menstrual cycle).
EFP-NF training, twice a week for a total of 10 sessions .
干预措施: EFP-NF training (Device)
TAU
Participant will receive no EFP-NF training, and continue their treatment as usual (TAU).
EFP-NF during HIGH estrogen phase
EFP-NF training, twice a week, during high-estrogen phases only (days 7-21 of a 28-day cycle), for a total of 10 sessions.
干预措施: EFP-NF training (Device)
EFP-NF during LOW estrogen phase
EFP-NF training, twice a week, during low-estrogen phases only (days 21-28 of a cycle and days 1-7 of the following cycle,based on a 28-day cycle), for a total of 10 sessions.
干预措施: EFP-NF training (Device)
结局指标
主要结局
Clinical measures- PSTD symptoms
时间窗: The clinical assessment will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment). Additional post-treatment measurements will be administrated at three follow-ups points; 1 month, 3 months and 6 months post
Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale (CAPS)
次要结局
- Changes in limbic system connectivity as measured by fMRI(fMRI will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).)
- Sleep quality- REM latency and sleep latency(Two nights; first, at pre-treatment (baseline) and second, post-treatment (up to two weeks post-treatment). A post-treatment evaluation will take place within two weeks post treatment (3-3.5 month since the beginning of the study).)
- Emotional regulation choice task(Emotional regulation tasks will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).)
- Self-report questionnaires- PCL (PTSD checklist )(The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment)
- Self-report questionnaires- Beck Depression Inventory (BDI-II)(The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment)
- Self-report questionnaires- State-trait Anxiety Inventory (STAI)(The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment)
- Self-report questionnaires- Toronto Alexithymia Scale (TAS)(The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment)
- Self-report questionnaires- Dissociative Experience Scale (DES)(The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment)
- Self-report questionnaires- Locus of Control (LOC)(The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment)
- Emotional regulation stroop task(Emotional regulation tasks will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).)