Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with Mild Cognitive Impairment or Mild Dementia: a Monocentric Randomized Controlled Pilot Trial (MindMoments-Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Activity Level
研究概览
简要总结
This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. A further aim is to investigate the feasibility of study procedures and to validate new questionnaire scores. Primary outcomes are the change in the patients' quality of life and in their overall activity level.
详细描述
Face-to-face behavioral activation therapy focusing on meaningful and enjoyable, physical, cognitive and social activities has shown positive effects on quality of life and activity level as well as long-term benefits on cognition and daily functioning in patients with MCI and mild dementia. In addition, effects on neuropsychiatric symptoms such as depression are reasonable as behavioral activation therapy has strong and consistent effects on patients with depression. However, effects of a highly scalable, digital version of behavioral activation therapy in patients with MCI or mild dementia are not proven so far. Therefore, this study primarily aims to explore effects of the digital health app MindAhead Active in adults with MCI or mild dementia in a pilot study.
The primary objective of this study is to explore effect sizes in different outcomes (primary outcomes: quality of life, overall activity level) that will be used to calculate the sample size of a larger trial. The secondary objective is the validation of instruments. The investigators aim to validate three questionnaires that may depict outcomes of the full-scale study in case of success.
Further objectives are to assess feasibility regarding the study (recruitment of eligible subjects, online assessment, study completion/dropout rates), and the intervention (app installation, usage and intervention adherence/completion) as well as to confirm findings from previously conducted studies on face-to-face behavioral activation therapy reporting no safety issues and no increase in adverse events in contrast to a control group. This trial is a monocentric, randomized controlled, assessor-blinded superiority trial with two parallel groups.
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
- Single (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
- •Diagnosis of cognitive impairment in MCI stage (ICD-10 codes: F06.7, F07.8) or mild dementia stage (ICD-10: F00.-*, F01.-, F03) due to all etiologies apart from etiologies described in F02.- (Pick's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, HIV, Lewy body disease). Hence, etiologies of MCI and mild dementia include
- •Alzheimer's disease (e.g., F00.-*)
- •Vascular disease (e.g., F01.-) (exception in case of stroke: event occurred > 12 months ago without ongoing spontaneous remission)
- •Mixed diseases
- •Unclear etiologies
- •MCI or mild dementia diagnosis assigned within the last 12 months by a neurologist or psychiatrist from our cooperation partners that fulfil adequate diagnosis procedures such as neuropsychological assessment, brain imaging, self- and/or third-party medical history interview, and potentially cerebrospinal fluid, positron emission tomography, or electrophysiological measures
- •MCI or mild dementia diagnosis confirmed by a treating physician
- •MMSE ≥ 24 or MoCA ≥ 18 (last date of assessment is decisive; needs to be within the last 12 months)
- •Sufficient physical fitness to engage in physical activities (e.g., walking or cycling) as confirmed by a treating physician
- •German language skills sufficient to understand German instructions of study assessments and of the intervention
- •Ability and sufficient vision to operate a smartphone
排除标准
- •possibly moderate or severe cognitive impairment (moderate or severe dementia), indicated by MMSE < 24 or MoCA < 18 (last date of assessment is decisive; needs to be within the last 12 months)
- •Specific brain injury events within the last 12 months or with ongoing spontaneous remission due to
- •Stroke (ischemic, hemorrhagic)
- •Traumatic brain injury
- •Specific etiologies of MCI or mild dementia (F02.-) that show a variable course or a fast progression including
- •Multiple sclerosis
- •Parkinson's disease
- •Pick's disease / Frontotemporal lobar degeneration
- •Lewy body disease
- •Brain tumors
- •Autosomal dominant form of Alzheimer's disease with early first manifestation
- •Creutzfeldt-Jakob disease
- •German language restrictions or visual restrictions which prevent from understanding written German instructions of assessment or intervention procedures (e.g. severe aphasia, lack of sufficient German language skills, severe non-corrected visual impairment)
研究组 & 干预措施
MindAhead + TAU Group
The intervention group receives the digital health app MindAhead Active for 3 months as well as treatment-as-usual (TAU, see Control intervention).
干预措施: MindAhead Active (Device)
MindAhead + TAU Group
The intervention group receives the digital health app MindAhead Active for 3 months as well as treatment-as-usual (TAU, see Control intervention).
干预措施: Treatment-as-usual (Other)
TAU Group
The control group receives TAU which may include antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins depending on clinical findings.
干预措施: Treatment-as-usual (Other)
结局指标
主要结局
Activity Level
时间窗: 3 months
Change in activity level (total score of social, physical and cognitive activity level) from baseline to 3-month follow-up. Overall activity level will be measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) German version. The CHAMPS assesses frequency and duration of 41 physical, cognitive, and social activities of a typical week within the last 4 weeks. As measure for activity level, we assess the total hours spend per week covering all performed 41 activities, by adding up the data on activity duration (as described by Poelke, et al., 2016, International Psychogeriatrics). Therefore, the duration scale for each item is transformed as described in the original work by Stewart et al. (2001, Medicine and Science in Sports and Exercise), with category 1 = 0.5 hours, 2 = 1.75 hours, 3 = 3.75 hours, 4 = 5.75 hours, 5 = 7.75 hours, and 6 = 9.75 hours. The composite score can range from 0 to 399.75 hours per week.
Overall Quality of Life
时间窗: 3 months
Change in quality of life (total score of generic and disorder-specific quality of life) from baseline to 3-month follow-up. Overall quality of life will be measured with a composite score of all items of the World Health Organization WHOQOL-BREF quality of life assessment and the Dementia Quality of Life (DEMQOL). All items will be transformed to a scale ranging from 0 to 100 and subsequently averaged. Higher scores indicate a higher quality of life.
次要结局
- Generic quality of life - environment subscale(3 months)
- Disorder-specific quality of life(3 months)
- Generic quality of life - composite score(3 months)
- Generic quality of life - psychological health subscale(3 months)
- Generic quality of life - social relationships subscale(3 months)
- Generic quality of life - physical health subscale(3 months)
- Cognitive activity level(3 months)
- Subjective cognitive symptoms - everyday memory(3 months)
- Subjective cognitive symptoms - global cognition(3 months)
- Goal-oriented activity level(3 months)
- Domain-specific activity level(3 months)
- Neurocognitive disorder-specific quality of life(3 months)
- Generic quality of life - global subscale(3 months)
- Physical activity level(3 months)
- Social activity level(3 months)
- Depressive symptoms(3 months)
- Chronic disease-specific quality of life(3 months)