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Completed

NCT Number: NCT04899089

Cognitive Training in Mild Cognitive Impairment

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60+ yrs of age
  • meet criteria for mild cognitive impairment
  • no neurological or psychiatric illness or dementia
  • non-gamers (<2 hour of video/brain training games/week over last 2 yrs)
  • proficient in English (reading and writing)
  • 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

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

Treatment and study plan

Cognitive training

Behavioral

The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.

Trivia Training

Behavioral

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.

Primary outcomes

  1. Objective Cognition - Computerized Cognitive Tasks

    Time frame: Up to 10 weeks

    Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).

  2. Subjective Cognitive Self-Efficacy. - Cognitive Failures Questionnaire

    Time frame: 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.

  3. Subjective Behavioral Sleep- Electronic Daily Sleep Diaries

    Time frame: 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.

  4. Subjective Behavioral Sleep- Insomnia Severity Index

    Time frame: 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.

  5. Objective Sleep-Watchpat

    Time frame: Up to 10 weeks

    Single night objective sleep recording via a wrist worn device.

Secondary outcomes

  1. Physiological Arousal- Heart Rate Variability

    Time frame: 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)

  2. Anxiety - State-Trait Anxiety Inventory

    Time frame: 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.

  3. Game-related experience- Sessions and duration played

    Time frame: 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.

  4. Circadian Rhythm- Morningness-Eveningness Questionnaire

    Time frame: 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.

  5. Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale

    Time frame: 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.

  6. Subjective Arousal- Arousal Predisposition Scale

    Time frame: 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.

  7. Game Engagement Questionnaire

    Time frame: Up to 10 weeks

    Questionnaire assessing the experience of the game.

  8. Mood-Depression-Beck Depression Inventory-II

    Time frame: 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.

  9. Alcohol Use - Alcohol Use Disorder Test

    Time frame: Baseline

    10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.

  10. Physical Activity - International Physical Activity Questionnaire

    Time frame: Up to 10 weeks

    7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.

  11. Personality - Big Five Inventory

    Time frame: Baseline

    10 question assessment measuring personality

  12. Computer Proficiency- Computer Proficiency Questionnaire

    Time frame: Baseline

    This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Acronym: TRAIN-MCI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 24, 2021
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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