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临床试验/NCT04953832
NCT04953832已完成不适用

Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
BOLD activation during cognitive task

研究概览

简要总结

Anxiety disorders are highly prevalent and costly to the individual and society. Exposure-based cognitive behavioral therapy (CBT) is the gold-standard intervention for anxiety disorders, although this approach does not fully reduce symptoms for all individuals. Therefore there is a need for innovative intervention approaches. One approach to augment and improve existing therapies would be to enhance the neurocognitive basis of fear extinction processes, which are the model on which treatments are based. Enhancing these processes may be possible through computerized cognitive training techniques which target executive functioning, the cognitive processes that help people manage complex cognitive activities. The proposed project is a proof-of-concept pilot study investigating the potential for training of executive functioning to improve anxiety-related outcomes. Individuals with elevated levels of social anxiety will be randomized to single-session COGnitive Enhancement Training (COGENT) or sham training program (ST). All participants will complete a single speech session where they present three 7-minute impromptu speeches and rate their anxiety at specific intervals. Participants will then complete the COGENT paradigm and affective processing task while undergoing fMRI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Screened positive for anxiety symptoms
  • •Between the ages of 18-55, inclusive.
  • •Have signed informed consent document(s) indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study.
  • •Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

排除标准

  • •Evidence of psychosis, bipolar disorder, or severe substance use disorder based on clinical cutoffs on self report measures
  • •Current neurological conditions based on brief medical history
  • •Current psychotherapy for anxiety or psychotropic medications
  • •MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body piercings, and pregnancy.
  • •Active suicidal ideation endorsed on the depression self-report measure.

研究组 & 干预措施

Cognitive Training + exposure

Experimental

Participants will complete adaptive computerized cognitive training plus a series of speech tasks

干预措施: Cognitive Training (Behavioral)

No training + exposure

Active Comparator

Participants will complete a low-dose computerized cognitive program plus a series of speech tasks

干预措施: Cognitive Training (Behavioral)

结局指标

主要结局

BOLD activation during cognitive task

时间窗: immediately after the intervention

Working Memory Span task during fMRI

BOLD activation during emotional task

时间窗: immediately after the intervention

Face processing task during fMRI

次要结局

  • Speech anxiety ratings(baseline, ratings during 3 speeches)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Bomyea

Assistant Professor

University of California, San Diego

研究点 (1)

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