Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Resting State Default Mode Network (DMN) Functional Connectivity
研究概览
简要总结
This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show greater default mode network (DMN) connectivity than healthy controls, at-risk adolescents will show greater changes in DMN connectivity than healthy controls, and that a longer session of mindfulness based neurofeedback will lead to greater reduction in DMN connectivity. To do so, 50 adolescents with elevated repetitive negative thinking and 50 matched healthy control participants will be enrolled into a double-blind randomized clinical trial of a session of mindfulness training with either active mindfulness-basde neurofeedback or sham mindfulness-based neurofeedback.
详细描述
A sample of 50 at-risk adolescents with elevated repetitive negative thinking and 50 matched healthy control participants, ages 13-21, will be enrolled into this double blind, randomized clinical trial. Healthy control participants will be matched for age and sex. All participants will complete a baseline clinical assessment and return within two weeks for a brief resting state MRI scan to assess default mode connectivity (DMN). At Visit 2, at-risk adolescents will then receive a 45-minute mindfulness training by clinically trained staff. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback. Participants and staff will remain blind to assignment. Participants will have fMRI scans for resting state functional connectivity before and after mindfulness practice. Participants will complete two doses (15 minutes per dose) of real or sham mbNF in the scanner. At-risk adolescents will also complete a follow-up clinical assessment at 4-weeks post-scan (Visit 3) and complete daily surveys for approximately four weeks from Visit 2 to Visit 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 13-21, inclusive
- •If <18 years old: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
- •If age ≥18 years: Competent and willing to provide written informed consent
- •Tanner puberty stage ≥3 (to minimize neuroendocrine variability)
- •Able to understand study procedures, read, and write in English
- •Access to a mobile device to complete daily surveys
- •Additional Inclusion Criteria for At-Risk Adolescents - Recurrent negative thinking, defined as PTQ/PTQ-C total score >30 with at least two items rated as 3 (Often) or 4 (Almost Always)
- •Additional Inclusion Criteria for Healthy Controls
- •PTQ/PTQ-C total score <15, with zero items rated as 3 (Often) or 4 (Always)
排除标准
- •Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, bipolar disorder, recurrent moderate or severe major depressive disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or obsessive compulsive disorder
- •Severe lifetime substance use disorder
- •Unstable medical or neurologic condition as determined by study staff, history of epilepsy or seizure disorder, head injury, loss of consciousness >5 minutes by participant self-report
- •MRI contraindications (i.e. presence of ferromagnetic implants, cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, magnetic dental implants claustrophobia).
- •Visual, auditory, or cognitive impairment (IQ<80 based on the Wechsler Abbreviated Intelligence Scale (WASI)) that may make it difficult to participate.
- •Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
- •Pregnancy: a negative pregnancy test is required at the time of enrollment for any individuals of childbearing potential
- •Individuals who are under the legal protection of the government or state (Wards of the State)
研究组 & 干预措施
Healthy Control (HC)
Healthy control participants will complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity. They will receive no intervention or comparator.
Mindfulness-based neurofeedback (mbNF)
Participants will:
- Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity
- Receive a 45-minute mindfulness training
- Receive two 15-minute sessions of mindfulness-based neurofeedback
干预措施: Mindfulness Training (Behavioral)
Mindfulness-based neurofeedback (mbNF)
Participants will:
- Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity
- Receive a 45-minute mindfulness training
- Receive two 15-minute sessions of mindfulness-based neurofeedback
干预措施: Mindfulness-based Neurofeedback (Real mbNF) (Behavioral)
Sham mindfulness-based neurofeedback (Sham mbNF)
Participants will: - Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity -Receive a 45-minute mindfulness training -Receive two 15-minute sessions of sham mindfulness-based neurofeedback
干预措施: Mindfulness Training (Behavioral)
Sham mindfulness-based neurofeedback (Sham mbNF)
Participants will: - Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity -Receive a 45-minute mindfulness training -Receive two 15-minute sessions of sham mindfulness-based neurofeedback
干预措施: Sham mindfulness-based neurofeedback (Sham mbNF) (Behavioral)
结局指标
主要结局
Resting State Default Mode Network (DMN) Functional Connectivity
时间窗: Baseline
We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Change in Within-Person Default Mode Network (DMN) Functional Connectivity
时间窗: Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF)
A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.
Time Effect on Within-DMN Connectivity
时间窗: Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)
A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Resting State Default Mode Network (DMN) Functional Connectivity
时间窗: Baseline
We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Change in Within-Person Default Mode Network (DMN) Functional Connectivity
时间窗: Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF)
A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.
Time Effect on Within-DMN Connectivity
时间窗: Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)
A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
次要结局
未报告次要终点
研究者
Anne Eden Evins
Cox Family Professor of Psychiatry
Massachusetts General Hospital