Digital Therapeutics for Insomnia: Assessing the Effectiveness of a Computerized Home-Based Cognitive Stimulation Program

Abstract

Background: Sleep disturbances represent a major health burden today, affecting up to one-third of the population worldwide. Computerized cognitive stimulation has been proven as an effective approach in diminishing negative symptomatology and improving the quality of life in a range of medical conditions. Given its nature in enhancing neural networks, such as those involved in stimulus monitoring and inhibitory processes, computerized cognitive stimulation is arising as a potential tool to overcome underlying cognitive deficits found among patients suffering from insomnia. In the current study, we report the results of Phase 1 and Phase 2 clinical trials of a home-based computerized cognitive stimulation program. Methods: The cognitive stimulation intervention followed a home-based approach with online supervision by a psychologist. The training activities were gamified cognitive tasks that had been designed to improve executive functions, with a focus on inhibition skills. The Insomnia Severity Index and the Pittsburgh Sleep Quality Index scales were used as the main assessment measures. Data from the Behavior Rating Inventory of Executive Function, the Beck Depression Inventory, the State-Trait Anxiety Inventory, and the Penn State Worry Questionnaire were also recorded before and after the intervention. During 15 consecutive days, participants performed on alternate days a total of 7 training sessions (each lasting 45 minutes). Results: Twelve patients with clinical insomnia were administered the home-based online cognitive stimulation program. After seven training sessions, mean changes in sleep quality, depressive and anxiety symptoms, worry thoughts, and everyday function were found, with significant improvements in these domains in the full absence of safety issues. Conclusions: In patients with insomnia, cognitive stimulation demonstrated improvements in sleep quality, mood, and cognitive performance over a 15-day protocol. No relevant side effects were reported. The long-term effectiveness of the intervention is still unknown. Clinical Trial Registration: The study protocol has been reviewed and published in ClinicalTrials.gov, assigning it the code NCT05050292 https://clinicaltrials.gov/ct2/show/NCT05050292?term=NCT05050292&draw=2&rank=1.

Effectiveness of a Computerized Home-Based Cognitive Stimulation Program for Treating Cancer-Related Cognitive Impairment

“…Regarding quality of life, the benefits of cognitive stimulation interventions remain uncertain. While some studies have shown improvements in quality of life in individuals with clinical insomnia after just seven sessions [ 74 ], studies in healthy elderly populations have not found significant differences in quality of life after either short-term (24 sessions performed twice a week) [ 117 ] or long-term (over 12 months) [ 118 ] cognitive stimulation programs that use electronic devices. Despite finding contradictory results in the literature, those studies that have included more than one training session per week, as in our case, have consistently reported improvements [ 109 ].…”

“…Advances in the understanding of this neural functioning have led to the development of a range of therapeutic applications in the form of cognitive stimulation interventions, which aim to improve brain function by increasing the strength and efficiency of neural connections [ 69 , 70 , 71 , 72 ]. These interventions can take the form of computer-based training programs or cognitive rehabilitation, and have been shown to be effective in improving cognitive function in individuals with a range of neurological and psychiatric disorders [ 73 , 74 , 75 , 76 , 77 , 78 , 79 ]. Therefore, considering the promising results from other diseases that are also linked to cognitive dysfunction, non-pharmacological intervention approaches based on cognitive stimulation represent a potential solution [ 80 ].…”

“…Therefore, considering the promising results from other diseases that are also linked to cognitive dysfunction, non-pharmacological intervention approaches based on cognitive stimulation represent a potential solution [ 80 ]. Thus, being considered as the enhancement of a cognitive skill through practice, cognitive stimulation programs include repetitive and standardized tasks, oriented to specific cognitive domains, and can be easily self-administered by the patient without the need for professional supervision, with an acceptable rate of dropouts [ 74 , 81 ]. In clinical settings, cognitive stimulation has been proven effective in numerous populations, with reports of cognitive improvement in patients with mood alterations [ 76 ], psychiatric disorders [ 82 ], neurodegenerative conditions [ 83 ], stroke [ 84 ], eating disorders [ 85 ], or sleep disturbances [ 74 , 86 ].…”

“…Thus, being considered as the enhancement of a cognitive skill through practice, cognitive stimulation programs include repetitive and standardized tasks, oriented to specific cognitive domains, and can be easily self-administered by the patient without the need for professional supervision, with an acceptable rate of dropouts [ 74 , 81 ]. In clinical settings, cognitive stimulation has been proven effective in numerous populations, with reports of cognitive improvement in patients with mood alterations [ 76 ], psychiatric disorders [ 82 ], neurodegenerative conditions [ 83 ], stroke [ 84 ], eating disorders [ 85 ], or sleep disturbances [ 74 , 86 ]. In this line, it is worth noting that the promising results of a first pilot study of cognitive stimulation aimed at patients with CRCI already suggested benefits in executive functions, information processing speed, and memory after intervention [ 87 ].…”

Cognitive decline monitoring through a web-based application

“…CogniFit’s general cognitive assessment (CAB) is an online neurocognitive assessment that aims to evaluate cognitive functions in the following domains: attention, perception, memory, executive functions, coordination, and physical, psychological, and social wellbeing. This instrument has been widely used for cognitive assessment ( Yaneva and Mateva, 2017 ; Sánchez-Sansegundo et al, 2021 ; Berbegal et al, 2022 ; Tapia et al, 2022 , 2023a , 2023b ; Duñabeitia et al, 2023 ).…”