Cognitive Training in Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Insomnia; Mild Cognitive Impairment
• Interventions: Behavioral: Cognitive Training; Behavioral: Trivia Training

• Registration Number: NCT04899089
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2021-07-28
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Game Training Condition	Cognitive Training	Participants complete an 8 week long computerized cognitive training intervention. Participants play the games for 45 minutes, three times per week.
Trivia Training Condition	Trivia Training	Participants complete an 8 week long computerized trivia training. Participants complete the trivia training for 45 minutes, three times per week.

Primary Outcome Measures

Name	Time	Method
Objective Sleep-Watchpat	Up to 10 weeks	Single night objective sleep recording via a wrist worn device.
Objective Cognition - Computerized Cognitive Tasks	Up to 10 weeks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).
Subjective Cognitive Self-Efficacy. - Cognitive Failures Questionnaire	Up to 10 weeks	A 25 item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.
Subjective Behavioral Sleep- Electronic Daily Sleep Diaries	Up to 10 days	Electronic Daily Sleep Diaries. Online diaries completed each morning (\~5 mins) during the study. Diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
Subjective Behavioral Sleep- Insomnia Severity Index	Up to 10 weeks	Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.

Secondary Outcome Measures

Name	Time	Method
Circadian Rhythm- Morningness-Eveningness Questionnaire	Up to 10 weeks	19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.
Physical Activity - International Physical Activity Questionnaire	Up to 10 weeks	7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
Personality - Big Five Inventory	Baseline	10 question assessment measuring personality
Anxiety - State-Trait Anxiety Inventory	Up to 10 weeks	Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
Game Engagement Questionnaire	Up to 10 weeks	Questionnaire assessing the experience of the game.
Physiological Arousal- Heart Rate Variability	Impact of game related experience will be measured at baseline	CorSense monitor assessed 5 min heart rate recordings both at rest. Time index variables: SDNN (standard deviation of normal to normal heartbeat intervals)
Game-related experience- Sessions and duration played	Up to 10 weeks	During the intervention phase the cognitive training group will play games and will need to log the days and duration played.
Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale	Up to 10 weeks	Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.
Mood-Depression-Beck Depression Inventory-II	Up to 10 weeks	21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.
Alcohol Use - Alcohol Use Disorder Test	Baseline	10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
Subjective Arousal- Arousal Predisposition Scale	Up to 10 weeks	Arousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.
Computer Proficiency- Computer Proficiency Questionnaire	Baseline	This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States