BrainFit: The Effect of Online Cognitive Training in Patients With Late Life Mood Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Appreciation of the intervention
研究概览
简要总结
This study evaluates the efficacy of an eight-week online cognitive training program on feasability and on objective and subjective cognitive functions in patients with late life mood disorders (LLMD). In the feasability study two training groups will be compared. The primary aim is to investigate feasability, measured by compliance attendance and satisfaction of the participants. The secondary aim is to study the possible effects of the intervention on cognitive functions. Additionally, effects on mood symptoms, social functioning, sense of mastery and quality of lide will be studied.
详细描述
BACKGROUND OF THE STUDY Late life mood disorders (LLMD) include patients with unipolar depression and bipolar disorder, aged 50 years and over. Despite the fact that evidence-based pharmacological and psychotherapeutic interventions have proven effective, many patients with LLMD experience relapse or partial remission.
One of the reasons for unfavorable treatment outcome is that LLMD are often accompanied with cognitive impairment (attention, processing speed, memory and executive function) during an episode and after remission.This cognitive impairment in LLMD is associated with worse social functioning , distress to patients and caregivers, decreased quality of life and an unfavorable prognosis, including nursing home admission.
Several dimensions of recovery can be distinguished and are known to influence each other. For example, addressing functional recovery by improving cognitive functioning may enhance clinical recovery (less mood symptoms) and social functioning . Therefore, addressing cognitive impairment in LLMD may improve overall functioning and recovery rates.
Strategies to improve cognitive functioning with cognitive training and/or remediation are lacking for LLMD. Cognitive training has been effective in healthy older adults and in patients with mild cognitive impairment (MCI) and dementia.
A meta-analysis of adult patients with major depressive disorder showed that computerized cognitive training is associated with improvement in depressive symptoms and everyday functioning, though effects on cognition are inconsistent, with moderate to large effects for attention, working memory and global functioning and no effects for executive functioning and verbal memory. However, a small study including both unipolar and bipolar adult patients (n=15) and a control group (n=16) observed improvements in shifting, divided attention, global executive control after an online cognitive training. In addition, improved subjective cognitive functioning, reduced depression levels and less difficulty in everyday coping were observed.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years and older
- •subjective cognitive complaints
- •early or partial remission of depressive episode with a diagnosis of unipolar recurrent depression (current episode is at least the third episode and shorter than 2 years) or bipolar disorder according to DSM 5 criteria.
- •have acces to internet on computer, tablet or lapyop
- •willing to sign informed consent
排除标准
- •current psychotic symptoms
- •severe suicidal ideations
- •severe personality disorder (as a main diagnosis)
- •severe alcohol or substance abuse
- •insufficient mastery of the Dutch language.
- •on 2 or more cognitive domains below 1 SD of the norm
- •moca < 22
结局指标
主要结局
Appreciation of the intervention
时间窗: Eight weeks (T1)
Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)
Feasability of the intervention measured via therapy compliance and drop-out
时间窗: Eight weeks (T1)
therapy compliance, drop-out
次要结局
- Physical activity via NZPAQ-SF(Eight weeks (T1) and 3 months (T2))
- Quality of life via the MANSA(Eight weeks (T1) and 3 months (T2))
- Believe and expectancy of the intervention via credibility/expectancy questionnaire(Week 0 (T0))
- Subjective cognitive functioning measured via the CFQ(Eight weeks (T1) and 3 months (T2))
- Mood symptoms via MADRS(Eight weeks (T1) and 3 months (T2))
- Social andf occupational functioning via SOFAS(Eight weeks (T1) and 3 months (T2))
- Genaral objective cognitive functioning via the MOCA(Eight weeks (T1) and 3 months (T2))
- Sense of Mastery via Mastery questionnaire(Eight weeks (T1) and 3 months (T2))
研究者
Annemiek Dols, MD, PhD
Psychiatrist, Prinicipal Investigator
Amsterdam UMC, location VUmc