Mild cognitive impairment (MCI) is often viewed as a transitional stage between normal aging and early stage of Alzheimer?s disease and related dementia. MCI affects up to 20% of the population of older adults, and sleep disturbances have been identified as one of the core neuropsychiatric problems in MCI. Sleep disturbances are associated with a range of negative outcomes for persons with MCI, including worsening cognitive function, physical function, depression, and fatigue, which can all lead to functional impairments that greatly reduce quality of life. One of the most common sleep disturbances in persons with MCI is insomnia, with a prevalence of 44%. While non-pharmacological treatments, especially in-person cognitive behavioral therapy for insomnia (CBTI), have demonstrated clinical efficacy in improving sleep and preserving cognitive function in the general population of older adults, there have been few studies focused on adapting CBTI for older adults with MCI. The goal of this SBIR Phase I is to develop and test a provider-supported, technology-enabled system to adapt and deliver evidence-based CBTI to persons with MCI and co-morbid insomnia, with the support of health providers. The proposed intervention combines internet/mobile-based delivery and smart messaging prompts as reminders to compensate for cognitive processes that can be impaired in MCI. Specific aims for this Phase I include: (1) Develop a technology-enabled system to deliver CBTI for older adults with MCI; (2) Conduct formative evaluations with persons with MCI to refine smart messaging prompts and test usability of the patient software platform, and cognitive interviews with providers to assess feasibility of implementing the intervention in the clinical setting; and (3) Conduct a six-week pilot randomized controlled trial to assess preliminary effectiveness and feasibility of the CBTI intervention. We hypothesize that participants in the CBTI intervention group will demonstrate a significant improvement in quality of sleep (both subjective and objective), and an improvement in cognitive and physical functioning, compared to those in the control group. Data collected in Phase I will be used to determine the sample size necessary for an adequately powered Phase II randomized trial. If successful, this product will contribute to the adoption and dissemination of a low-cost, multi-technology enabled CBTI intervention to reduce sleep disturbances, and improve cognitive and physical function among persons with MCI. A successful Phase II study will result in a technology-enabled program that can benefit multiple types of provider organizations (mental health clinics, primary care clinics, and geriatric clinics) serving large numbers of older adults with MCI, thus having significant commercial potential.
Project Terms: actigraphy; Adherence; Adoption; Adult; Adverse effects; Affect; Alzheimer's Disease; arm; base; Behavior Therapy; Behavioral; Clinic; Clinical; clinical efficacy; cloud based; Cognitive; cognitive function; cognitive process; Cognitive Therapy; Columbidae; Communication; Comorbid Insomnia; Computer software; Control Groups; cost; Data; Dementia; design; Eagles; Effectiveness; Elderly; Emerging Technologies; evidence base; Evidence based practice; experience; Fatigue; formative assessment; functional disability; General Population; Goals; Grant; group intervention; Health; Health Personnel; Home Care Agencies; human old age (65+); hypnotic; Impairment; improved; innovative technologies; interest; Internet; Intervention; Interview; Lead; Machine Learning; Measures; Mental Depression; Mental Health; Meta-Analysis; mild cognitive impairment; Modification; Motivation; neuropsychiatric disorder; neuropsychiatry; normal aging; older patient; Older Population; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Phase; phase 2 study; Physical Function; Pilot Projects; Population; preference; Prevalence; Primary Health Care; programs; Provider; Quality of life; Randomized Controlled Trials; randomized trial; Sample Size; Severities; Sleep; Sleep Disorders; Sleep disturbances; sleep onset; sleep quality; Sleeplessness; Small Business Innovation Research Grant; software systems; Symptoms; System; Technology; Testing; Text; Time; treatment response; United States; usability; Work;
