Cognitive Training in Mild Cognitive Impairment (TRAIN-MCI)

October 27, 2023 updated by: Ashley Curtis, University of Missouri-Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 10 weeks
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).
Up to 10 weeks
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.
Up to 10 weeks
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.
Up to 10 days
Objective Sleep-Watchpat
Time Frame: Up to 10 weeks
Single night objective sleep recording via a wrist worn device.
Up to 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 10 weeks
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.
Up to 10 weeks
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.
Up to 10 weeks
Game Engagement Questionnaire
Time Frame: Up to 10 weeks
Questionnaire assessing the experience of the game.
Up to 10 weeks
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.
Up to 10 weeks
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.
Baseline
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.
Up to 10 weeks
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.
Baseline
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)
Impact of game related experience will be measured at baseline
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.
Up to 10 weeks
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.
Up to 10 weeks
Personality - Big Five Inventory
Time Frame: Baseline
10 question assessment measuring personality
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashley Curtis, PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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