Remote Cognitive Remediation for Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Changes in composite neurocognition scores from the CNS Vitals Signs battery
研究概览
简要总结
Major depressive disorder is the number one cause of disability worldwide. Evidence regarding the effectiveness of various treatments for patients with severe depression is still lacking. Although many patients achieve treatment response, only a minority of patients achieve full remission and even fewer sustain it. In fact, within one month 10% will be re-hospitalized and the rate climbs to 30% within a year. Further, remission from depressive symptoms is a surprisingly poor predictor of recovery of community functioning following discharge. It is clear that the traditional focus on diagnostic symptoms is insufficient for promoting a full return to everyday functioning. The present aim is to examine the efficacy and effectiveness of treating neurocognition, a symptom that explains persistent deficits in community functioning for those with depression. The study design that maps on to the contemporary clinical setting, in order to reflect the changing landscape of inpatient and community treatment.
详细描述
Cognitive impairment in depression has emerged as one of the most robust predictors of sustained impairment in everyday functioning. Significant deficits in attention, memory and executive function are widespread and remain even after effective treatment of primary mood symptoms. Relevant to the investigators aims, severity of cognitive impairments has been linked to more severe episodes and higher rates of relapse. Cognitive Remediation (CR) is a psychological treatment developed and tested in research settings, where techniques that train the brain to process information more efficiently result in improvements in cognition and in community functioning. Contemporary CR relies on three pillars of treatment: Drill and Practice, Strategic Monitoring, and Bridging of Cognitive Skills to Everyday Life. CR treatment produces robust effects in depression, with some evidence for transfer to reduced depressive symptoms. However, each of the three pillars is typically done within a group therapy context, with two or more meetings per week, presenting a challenge to both modern health care models and the symptoms of depression that would be barriers to attendance (low motivation, social anxiety, lack of energy). The investigators have recently developed a Remote Cognitive Remediation program that overcomes these obstacles with novel components of CR to allow for delivery of treatment remotely. These techniques include the use of online exercises for an increased dose, and the delivery of recorded visual examples of bridging strategies. Efficacy (cognitive improvement) and effectiveness (improved community functioning, reduced time to relapse) will be compared to a placebo control group in this 12-week randomized controlled trial with 6-month follow-up assessments.
This project has the potential to address a significant gap in the treatment of depression and to modify an established treatment to fit into the changing demands of the health care system.
Aim 1: To examine whether cognitive remediation, delivered at home over the Internet, is efficacious in improving cognition in symptomatic individuals with recurrent MDD.
Aim 2: To examine the effectiveness of remote cognitive remediation for improving community functioning.
Aim 3: To examine the baseline and dynamic predictors and mediators of change in functioning for patients with MDD who receive cognitive remediation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a primary diagnosis of Major Depressive Disorder
排除标准
- •Medical conditions that affect central nervous system functioning, substance abuse within the past three months (assessed with the SCID-V), and sensory or perceptual conditions that affect validity of testing.
研究组 & 干预措施
Active Cognitive Remediation -Long-term
Participants in the long-term treatment will receive 24 weeks of active cognitive remediation. Participants will complete 24 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Active Cognitive Remediation (Behavioral)
Active Cognitive Remediation -Long-term
Participants in the long-term treatment will receive 24 weeks of active cognitive remediation. Participants will complete 24 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Online computer exercises (Behavioral)
Active Cognitive Remediation -Long-term
Participants in the long-term treatment will receive 24 weeks of active cognitive remediation. Participants will complete 24 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Strategy monitoring (Behavioral)
Active Cognitive Remediation -Long-term
Participants in the long-term treatment will receive 24 weeks of active cognitive remediation. Participants will complete 24 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Bridging strategies (Behavioral)
Active Cognitive Remediation -Short-term
Participants in the short-term treatment will receive 12 weeks of active cognitive remediation (the standard length of time in the literature). Participants will complete 12 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Online computer exercises (Behavioral)
Active Cognitive Remediation -Short-term
Participants in the short-term treatment will receive 12 weeks of active cognitive remediation (the standard length of time in the literature). Participants will complete 12 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Strategy monitoring (Behavioral)
Active Cognitive Remediation -Short-term
Participants in the short-term treatment will receive 12 weeks of active cognitive remediation (the standard length of time in the literature). Participants will complete 12 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Active Cognitive Remediation (Behavioral)
Active Cognitive Remediation -Short-term
Participants in the short-term treatment will receive 12 weeks of active cognitive remediation (the standard length of time in the literature). Participants will complete 12 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.
干预措施: Bridging strategies (Behavioral)
Cognitive Remediation Control
Participants in the comparison training group will login to the same training environment but the cognitive load will not adjust as it does in the experimental conditions. Participants in this group will complete 12 weeks of on-line computer exercises.
干预措施: Cognitive Remediation Control (Behavioral)
Cognitive Remediation Control
Participants in the comparison training group will login to the same training environment but the cognitive load will not adjust as it does in the experimental conditions. Participants in this group will complete 12 weeks of on-line computer exercises.
干预措施: Online computer exercises (Behavioral)
Cognitive Remediation Control
Participants in the comparison training group will login to the same training environment but the cognitive load will not adjust as it does in the experimental conditions. Participants in this group will complete 12 weeks of on-line computer exercises.
干预措施: Strategy monitoring (Behavioral)
Cognitive Remediation Control
Participants in the comparison training group will login to the same training environment but the cognitive load will not adjust as it does in the experimental conditions. Participants in this group will complete 12 weeks of on-line computer exercises.
干预措施: Bridging strategies (Behavioral)
结局指标
主要结局
Changes in composite neurocognition scores from the CNS Vitals Signs battery
时间窗: Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.
Neurocognitive Measure
次要结局
- Virtual Reality Functional Capacity Test(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- Composite neurocognition score from the CNS Vitals Signs battery(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- Bell-Lysaker Emotion Recognition Task(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- World Health Organization Quality of Life(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- Montgomery-Asberg Depression Rating Scale(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- Sheehan Disability Scale(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- Lam Employment Absence and Productivity Scale(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
- Need for Cognition Scale(Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention.)
研究者
Dr. Christopher Bowie
Professor
Queen's University