Clinical trial NCT04899089: Cognitive Training in Mild Cognitive Impairment
Official title: Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Mild Cognitive Impairment
Keywords: cognitive training
insomnia
mild cognitive impartment
older adults
sleep
cognition
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Older adults (60+ years of age) who meet criteria for mild cognitive impairment and insomnia will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and arousal at baseline, and post-intervention. For cognitive training, participants will be provided with login information to access the computerized training, and will complete 8 weeks (45 mins 3x/week) of cognitive training. For trivia training, participants will receive weekly emails that contain trivia assignments that they will complete for 8 weeks (45 mins 3x/week). We will evaluate short-term (i.e., post-training) effects of the two training conditions on subjective anxiety, sleep, arousal, and subjective and objective cognition.


Eligibility criteria: Inclusion Criteria:

1. 60+ yrs of age
2. meet criteria for mild cognitive impairment
3. no neurological or psychiatric illness or dementia
4. non-gamers (\<2 hour of video/brain training games/week over last 2 yrs)
5. proficient in English (reading and writing)
6. meet clinical dx criteria for Insomnia (e.g., insomnia complaints for 6+ months, complaints occur despite adequate opportunity and circumstances for sleep, consist of one of the following: difficulty falling asleep, staying asleep, or waking up too early, and daytime dysfunction due to insomnia)

Exclusion Criteria:

1. unable to provide informed consent
2. unable to undergo randomization
3. other sleep disorder (e.g., sleep apnea, restless legs syndrome)
4. severe untreated psychiatric comorbidity
5. psychotropic or other medications that alter sleep (unless stabilized for 6 months)
6. uncorrected visual/auditory impairments
7. participation in nonpharmacological tx for sleep/fatigue/mood/cognition outside the current study

Primary outcomes:
measure: Objective Cognition - Computerized Cognitive Tasks
timeFrame: Up to 10 weeks
measure: Subjective Cognitive Self-Efficacy. - Cognitive Failures Questionnaire
timeFrame: Up to 10 weeks
measure: Subjective Behavioral Sleep- Electronic Daily Sleep Diaries
timeFrame: Up to 10 days
measure: Subjective Behavioral Sleep- Insomnia Severity Index
timeFrame: Up to 10 weeks
measure: Objective Sleep-Watchpat
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Physiological Arousal- Heart Rate Variability
timeFrame: Impact of game related experience will be measured at baseline
measure: Anxiety - State-Trait Anxiety Inventory
timeFrame: Up to 10 weeks
measure: Game-related experience- Sessions and duration played
timeFrame: Up to 10 weeks
measure: Circadian Rhythm- Morningness-Eveningness Questionnaire
timeFrame: Up to 10 weeks
measure: Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale
timeFrame: Up to 10 weeks
measure: Subjective Arousal- Arousal Predisposition Scale
timeFrame: Up to 10 weeks
measure: Game Engagement Questionnaire
timeFrame: Up to 10 weeks
measure: Mood-Depression-Beck Depression Inventory-II
timeFrame: Up to 10 weeks
measure: Alcohol Use - Alcohol Use Disorder Test
timeFrame: Baseline
measure: Physical Activity - International Physical Activity Questionnaire
timeFrame: Up to 10 weeks
measure: Personality - Big Five Inventory
timeFrame: Baseline
measure: Computer Proficiency- Computer Proficiency Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Ashley Curtis, PhD
role: PRINCIPAL_INVESTIGATOR
References: