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临床试验/NCT05383248
NCT05383248已完成不适用

Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Reward Maximization

研究概览

简要总结

Anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in many psychiatric illnesses, particularly depression and anxiety disorders. Untreated anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive behavioral treatment approaches to target anhedonia are fraught with poor patient compliance in real-life settings. The proposed study aims to address this gap by 1) testing the usefulness of a non-invasive, computationally informed, cognitive training in boosting reward sensitivity and reducing anhedonia in depressed and anxious patients, and 2) delineating the neurocomputational mechanisms of change associated with such intervention. In other words, can we train the brain to obtain rewards and boost positive mood among depressed and anxious individuals? This project will help to develop a computational training protocol aimed at reducing anhedonia and improving existing interventions for psychiatric conditions characterized by reward processing deficits. Long-term goals include expanding this framework to a broader range of appetitive and social stimuli to develop precise cognitive training tools to treat anhedonia.

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
Double (Participant, Outcomes Assessor)

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

入选标准

  • Age 18-65 (all races, both males and females will be included)
  • Current diagnosis of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD)
  • A score < 7 on the Snaith-Hamilton Pleasure Scale (SHAPS) or < 25 on the Positive Affect subscale from the Positive And Negative Affect Scale (PANAS)
  • Sufficient proficiency in English language to understand and complete informed consent, interviews, questionnaires, and all other study procedures.
  • Having normal or corrected vision
  • Having normal or corrected hearing

排除标准

  • Endorsement of past or current psychotic or bipolar disorder.
  • Endorsement of recent severe alcohol or substance use disorder (past 3 months).
  • Inability to discontinue for 48 hours prior to scan any medications incompatible with measuring reliable/interpretable neural activity (e.g., e.g., benzodiazepines/beta-blockers, atypical anti-depressants, anxiolytics and sedative hypnotics, antipsychotics, and opioid analgesics)
  • Being unsafe to undergo functional magnetic resonance imaging (fMRI), i.e., being pregnant, presence of non-removable metal in body, medical conditions that are incompatible with safe MRI (e.g., claustrophobia, inability to lie still on one's back for approximately 60 minutes; prior neurosurgery)
  • Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation): These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.

结局指标

主要结局

Reward Maximization

时间窗: Change between Pre-Training and Post-Training Assessments (about 20 min)

Individually fitted computational parameter of reward maximization strategy during the reward learning task

Positive Affect

时间窗: Change between Pre-Training and Post-Training Assessments (about 20 min)

State positive affect measured with the Positive and Negative Affect Schedule (PANAS)

Neural Tracking of Reward Expectation

时间窗: Change between Pre-Training and Post-Training Assessments (about 20 min)

Neural activity, i.e., blood oxygen level dependent (BOLD) response, in the striatum and medial prefrontal cortex correlating with participants' trial-level model-based reward expectations and associated prediction errors during the Reward Learning Task

次要结局

未报告次要终点

研究者

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

Katia Harle

Assistant Clinical Professor

University of California, San Diego

研究点 (2)

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