Cognitive Training in Mild Cognitive Impairment (TRAIN-MCI)

Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Cognitive Training; Behavioral: Trivia Training

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Game Training Condition; Participants complete an 8 week long computerized cognitive training intervention. Participants play the games for 45 minutes, three times per week.	Behavioral: Cognitive Training; The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
Active Comparator: Trivia Training Condition; Participants complete an 8 week long computerized trivia training. Participants complete the trivia training for 45 minutes, three times per week.	Behavioral: Trivia Training; The computerized trivia training asks participants to answer general questions related to pop culture, science, geography, etc. Participants can use online sources to search for answers and will be provided feedback on their accuracy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Behavioral Sleep- Insomnia Severity Index	Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.	Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).	Up to 10 weeks
Subjective Cognitive Self-Efficacy. - Cognitive Failures Questionnaire	A 25 item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.	Up to 10 weeks
Subjective Behavioral Sleep- Electronic Daily Sleep Diaries	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.	Up to 10 days
Objective Sleep-Watchpat	Single night objective sleep recording via a wrist worn device.	Up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety - State-Trait Anxiety Inventory	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.	Up to 10 weeks
Game-related experience- Sessions and duration played	During the intervention phase the cognitive training group will play games and will need to log the days and duration played.	Up to 10 weeks
Circadian Rhythm- Morningness-Eveningness Questionnaire	19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.	Up to 10 weeks
Game Engagement Questionnaire	Questionnaire assessing the experience of the game.	Up to 10 weeks
Mood-Depression-Beck Depression Inventory-II	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.	Up to 10 weeks
Alcohol Use - Alcohol Use Disorder Test	10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.	Baseline
Physical Activity - International Physical Activity Questionnaire	7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.	Up to 10 weeks
Computer Proficiency- Computer Proficiency Questionnaire	This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.	Baseline
Physiological Arousal- Heart Rate Variability	CorSense monitor assessed 5 min heart rate recordings both at rest. Time index variables: SDNN (standard deviation of normal to normal heartbeat intervals)	Impact of game related experience will be measured at baseline
Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale	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.	Up to 10 weeks
Subjective Arousal- Arousal Predisposition Scale	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.	Up to 10 weeks
Personality - Big Five Inventory	10 question assessment measuring personality	Baseline

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Ashley Curtis, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: sleep; older adults; cognition; insomnia; cognitive training; mild cognitive impartment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Cognition Disorders; Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2053302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will be assigned a participant number and de-identified. De-identified data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes