跳至主要内容
临床试验/NCT03275571
NCT03275571终止不适用

The Effects of Computerized Cognitive Behavior Therapy (cCBT) on Brain Health: A Feasibility Study

McGill University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Self-reported cognitive difficulties (C3Q)

研究概览

简要总结

Among people with HIV, the severity of depressive symptoms has repeatedly been associated with the presence of self-reported cognitive difficulties, even in the absence of impairment on neuropsychological testing. There is uncertainty about the clinical importance of these self-reports, especially when neuropsychological testing is normal.

However, there is growing evidence that these self-reports are clinically important. For example, among patients with major depressive disorder (MDD), evidence suggests that functional impairments is mediated by self-reported cognitive dysfunction, rather than objective cognitive dysfunction. Treatment of depression with Cognitive-Behaviour Therapy (CBT) has been shown to improve depressive symptoms and psychosocial functioning in patients with recurrent major depressive disorder, but there are few studies of the impact of psychotherapy on self-reported cognition and cognitive performance. Good Days Ahead (GDA) is a computerized treatment program developed to address symptoms of depression and anxiety. It teaches the basic principles of computerized behavioral therapy (CBT) in nine therapy sessions, each typically taking 30 minutes to complete. GDA has been found to be as effective as face-to-face CBT in decreasing symptoms of depression and anxiety.

The hypothesis is that people whose depressive symptoms are reduced following treatment with cCBT will also report fewer cognitive difficulties than before treatment. A second hypothesis is that changes in self-reported cognition will be concordant with changes in cognitive performance, such that people who make no improvement in self-report cognition will also show no improvement in cognitive performance and those who do improve on self-report will improve on cognitive performance.

详细描述

Among people with HIV, the severity of depressive symptoms has repeatedly been associated with the presence of self-reported cognitive difficulties, even in the absence of impairment on neuropsychological testing. There is uncertainty about the clinical importance of these self-reports, especially when neuropsychological testing is normal, as they are thought to be susceptible to patients' biases and insights into their illness.

However, there is growing evidence that these self-reports are clinically important. Among patients with major depressive disorder (MDD), evidence suggests that functional impairments is mediated by self-reported cognitive dysfunction, rather than objective cognitive dysfunction. For example, Buist-Bouwman et al reported that more than one-quarter of the impact of MDD on work loss was directly attributable to self-reported cognitive difficulties and that cognition was a significant mediator of the association between MDD and work or role dysfunction.

When depression is treated with antidepressant medication, some degree of improvement on neuropsychological tests has been documented. However, many studies have evaluated cognitive outcomes before and after treatment rather than comparing them with placebo, potentially biasing the results by learning effects, which limits the strength of the conclusions that can be drawn.

Treatment of depression with Cognitive-Behaviour Therapy (CBT) has been shown to improve depressive symptoms and psychosocial functioning in patients with recurrent major depressive disorder, but there are few studies of the impact of psychotherapy on self-reported cognition and cognitive performance. In a group of patients with highly recurrent depression (≥4 episodes) over 2 years of follow-up, Conradi et al showed that those randomized to receive psycho-education plus CBT reported the presence of cognitive symptoms significantly less of the time compared to those receiving psycho-education only (15% of the time or 3.6 months compared to 47% or 11.3 months).

In the HIV population, a single study has examined the effect of treatment of depression on self-reported cognitive difficulties and performance on neuropsychological tests, as part of a randomized controlled trial of antidepressant efficacy. Following 12 weeks of antidepressant treatment, HIV+ individuals who reported a decrease in depressive symptoms also reported significantly fewer cognitive difficulties, despite an absence of improvement on neuropsychological testing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Participants in the cohort study "Understanding and Optimizing Brain Health in HIV Now" with at least one remaining visit
  • Able to communicate (understand and read) in English
  • Depression subscale of the HADS (HADS-D) ≥ 8
  • Presence of self-reported cognitive difficulties (PDQ) >40
  • Score on the B-CAM > 14
  • Willing to undergo 9 sessions of cCBT as per instructions and to have weekly contact with a research coordinator from the central site (by email or phone)
  • Access to the internet

排除标准

  • Current use of street drugs (excluding marijuana)

研究组 & 干预措施

cCBT intervention

Experimental

Over the course of 9 weeks, 30 min online sessions, once per week, with a fictive therapist.

干预措施: cCBT intervention (Behavioral)

结局指标

主要结局

Self-reported cognitive difficulties (C3Q)

时间窗: One week before the beginning of the intervention and up to 4 weeks after the end of the intervention

The Communicating Cognitive Concerns Questionnaire evaluated cognitive concerns participants may have.

次要结局

  • Depressive symptoms measure (HADS)(One week before the beginning of the intervention and up to 4 weeks after the end of the intervention)
  • Cognitive Performance measure (B-CAM)(Up to 9 months before the beginning of the intervention and up to 2 months after the end of the intervention.)

研究者

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

Marie-Josée Brouillette

Associate Professor

McGill University

研究点 (2)

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