Graduated Sensory Salience as an Intervention for Intrusive Negative Thinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Sustained attention composite (computer based tasks and physiological measures)
研究概览
简要总结
Intrusive negative thinking styles such as rumination are typical of many psychiatric disorders, are difficult to treat, and predict poor treatment outcome. The investigators propose to evaluate a new intervention for negative thinking that capitalizes and builds on the preserved ability to attend to physical sensation. The investigators will examine changes in physiological mechanisms and symptoms.
详细描述
Intrusive negative cognitions are key features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention capitalizing on a preserved neurocircuitry for attending to evolutionarily salient somatosensory stimuli can be used to train attentional mechanisms to override otherwise pre-potent negative cognitions. The initial period will involve open-label intervention refinement and mechanistic evaluation of mechanism; N=35 individuals with high levels of intrusive negative cognitions and dysphoria will be assessed pre/post intervention in the graded sensory training condition. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology. The second phase will be a randomized trial of 70 participants equally allocated to graded and non-graded training conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Refusal or inability to provide informed consent
- •Current alcohol or substance dependence
- •Psychotic disorders or psychosis
- •Neurological disorders (stroke, Alzheimer's, Parkinson's, epilepsy, etc.)
- •Inability to complete questionnaires in English. The justification is that many of the primary analyses involve assessment of change in self-reported symptoms using measures normed in English. Participants must thus be able to read those measures to give valid indications of the extent to which they have responded to the intervention.
- •Current use of any psychotropic drugs thought to affect learning, including antipsychotics, anticonvulsants, stimulants, and anti-Parkinsonian drugs. Current is defined as within 2 weeks of testing, 4 weeks for fluoxetine.
- •Chronic pain that could be exacerbated by transcutaneous electrical stimulation
- •Having any eye problems or difficulties in corrected vision or hearing
- •Having a North American Adult Reading Test (NAART) equivalent Full Scale Intelligence Quotient < 85
- •Being pregnant. Determined by self-report at the interview and by a pregnancy test
- •Severe or poorly controlled concurrent medical disorders that may cause thinking disruptions or require medication that could cause negative thinking
- •Current use of medications that could cause affect thinking symptoms. That is, participants need to be able to think clearly to complete the proposed information processing tasks. And they need to be able to learn to be able to make use of the intervention. Medications which compromise clear thinking or which block learning will thus be considered exclusion criteria.
- •Any implanted electrical device (pacemaker, vagus nerve stimulator implant, etc.) or prior treatment with a vagus nerve stimulator
- •Underwent electroconvulsive therapy (ECT) < 9 months prior to study entry.
- •People who have foreign objects in their body that are not cleared for safety at 3 Tesla scanning, such as aneurysm clips or pacemakers, will be excluded from the fMRI portion of the study.
- •Participants deemed "not a good fit" for the study for other reasons (such as, but not limited to, continually arriving late or rescheduling, not being a trustworthy historian or accurate reporter of symptoms, being belligerent with study staff, or presenting an active suicide risk) can also be excluded.
- •Any heart condition
结局指标
主要结局
Sustained attention composite (computer based tasks and physiological measures)
时间窗: two weeks (five intervention days)
Sustained attention is operationalized by performance on computer-based tasks (sensitivity, reaction times) and associated physiological measures (pupil dilation, eye movements, heart rate, EEG) and central measures (fMRI derived reactivity in affect, somatosensory, and attention networks). These metrics will be interpreted together as a meta-analytic composite by counting the number of component measures with significant change in association with the intervention in comparison to a permutation-test derived critical number of indices change under the null hypothesis given the autocorrelation of the administered measures.
次要结局
- Depressive severity (patient self-report)(two weeks (five intervention days))
- Rumination (patient self-report)(two weeks (five intervention days))
研究者
Greg Siegle
Associate Professor of Psychiatry
University of Pittsburgh