Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)
研究概览
简要总结
The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).
详细描述
The focus of this study is Aim 1.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-60,
- •be able to provide written informed consent,
- •meet criteria for BPD on semi-structured clinical interview,
- •able to plan to keep any prescribed medications and psychotherapy constant during the study
- •fluent in English.
排除标准
- •current DBT psychotherapy outside the study
- •lifetime primary psychotic disorder
- •manic episode in the last one year
- •developmental disorder (e.g. autism)
- •history of learning disorder
- •severe substance use disorder in the last 3 months
- •active suicidal ideation with intent or plan in the past 3 months
- •history of major medical or neurologic disorder
- •MRI contraindications, including pregnancy
- •poor performance on reading task (WRAT > 11 errors)
- •newly prescribed medications in the past 8 weeks
- •daytime sedating medications (e.g. benzodiazepines, opiates, sedating neuroleptics)
- •any scheduled daily benzodiazepines
- •change in psychotherapy type or frequency in the past 12 weeks.
- •At the discretion of the study PI
- •Eligibility will be determined by study personnel.
研究组 & 干预措施
mindfulness-based Neurofeedback
Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
干预措施: mindfulness-based Neurofeedback (Behavioral)
control Neurofeedback
Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
干预措施: control Neurofeedback (Other)
结局指标
主要结局
Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)
时间窗: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Defined as within-DMN connectivity as the resting state seed-based connectivity between core nodes of medial prefrontal cortex (mPFC) and posterior cingulate cortex (PCC). Change = post-NF within-DMN connectivity - pre-NF within-DMN connectivity.
Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback
时间窗: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Defined as DMN-FPCN anticorrelation as the fMRI seed-based connectivity from mPFC to dorsolateral prefrontal cortex (dlPFC)). Change = post-NF mPFC-dlPFC anticorrelation - pre-NF mPFC-dlPFC anticorrelation
次要结局
- Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.(From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day)