跳至主要内容
临床试验/NCT05719909
NCT05719909暂停不适用

Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
1
主要终点
Quick Inventory of Depressive Symptoms

研究概览

简要总结

In a sample of patients already receiving esketamine treatment as part of their clinical care, this project seeks to test whether we can improve depression by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient aged 18-80 in the esketamine clinic in the Center for Interventional Psychiatry. The clinic's extensive screening and eligibility criteria for esketamine treatment will not be altered in any way, other than imposing the study-specific age range and the two

排除标准

  • Exclusion Criteria:
  • Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment.
  • Patients who, in the judgment of the esketamine clinical medical director, show signs of intellectual disability, developmental disability, and/or cognitive impairment (including age-related cognitive decline) of a sufficient degree to interfere with engagement in any study procedure.

研究组 & 干预措施

Cognitive Training

Experimental

8 sessions of web-based cognitive training

干预措施: Cognitive Training (Behavioral)

Sham Training

Sham Comparator

8 sessions of web-based sham training

干预措施: Sham Training (Behavioral)

结局指标

主要结局

Quick Inventory of Depressive Symptoms

时间窗: Trajectories from baseline through 1 month

Self-reported depression (range: 0-27; higher scores = worse outcome)

Montgomery Asberg Depression Rating Scale

时间窗: Trajectories from baseline through 1 month

depression severity; range 0-60; high score=worse outcome

次要结局

  • Frequency of scheduled esketamine visits(During first month)
  • Clinical Global Impression Scale--Severity(Trajectories from baseline through 1 month)
  • Clinical Global Impression Scale--Improvement(Trajectories from baseline through 1 month)
  • Number of patients terminated from esketamine therapy(During first 6 months)
  • Hamilton Depression Rating Scale modified score(Trajectories from baseline through 1 month)

研究者

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

Rebecca Price

Associate Professor of Psychiatry and Psychology

University of Pittsburgh

研究点 (1)

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