Back to resultsCognitive Training in Mild Cognitive Impairment (TRAIN-MCI)
Primary Purpose
Insomnia, Mild Cognitive Impairment
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Trivia Training
Sponsored by
About this trial
This is an interventional other trial for Insomnia focused on measuring cognitive training, insomnia, mild cognitive impartment, older adults, sleep, cognition
Eligibility Criteria
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
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video Game Training Condition
Trivia Training Condition
Arm Description
Participants complete an 8 week long computerized cognitive training intervention. Participants play the games for 45 minutes, three times per week.
Participants complete an 8 week long computerized trivia training. Participants complete the trivia training for 45 minutes, three times per week.
Outcomes
Primary Outcome Measures
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).
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.
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.
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.
Objective Sleep-Watchpat
Single night objective sleep recording via a wrist worn device.
Secondary Outcome Measures
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)
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.
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.
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.
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.
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.
Game Engagement Questionnaire
Questionnaire assessing the experience of the game.
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.
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.
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.
Personality - Big Five Inventory
10 question assessment measuring personality
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.
Full Information
NCT ID
NCT04899089
First Posted
May 19, 2021
Last Updated
June 9, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04899089
Brief Title
Cognitive Training in Mild Cognitive Impairment
Acronym
TRAIN-MCI
Official Title
Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Mild Cognitive Impairment
Keywords
cognitive training, insomnia, mild cognitive impartment, older adults, sleep, cognition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video Game Training Condition
Arm Type
Experimental
Arm Description
Participants complete an 8 week long computerized cognitive training intervention. Participants play the games for 45 minutes, three times per week.
Arm Title
Trivia Training Condition
Arm Type
Active Comparator
Arm Description
Participants complete an 8 week long computerized trivia training. Participants complete the trivia training for 45 minutes, three times per week.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
Intervention Type
Behavioral
Intervention Name(s)
Trivia Training
Intervention Description
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 Outcome Measure Information:
Title
Objective Cognition - Computerized Cognitive Tasks
Description
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).
Time Frame
Up to 10 weeks
Title
Subjective Cognitive Self-Efficacy. - Cognitive Failures Questionnaire
Description
A 25 item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.
Time Frame
Up to 10 weeks
Title
Subjective Behavioral Sleep- Electronic Daily Sleep Diaries
Description
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.
Time Frame
Up to 10 days
Title
Subjective Behavioral Sleep- Insomnia Severity Index
Description
Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
Time Frame
Up to 10 weeks
Title
Objective Sleep-Watchpat
Description
Single night objective sleep recording via a wrist worn device.
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Physiological Arousal- Heart Rate Variability
Description
CorSense monitor assessed 5 min heart rate recordings both at rest. Time index variables: SDNN (standard deviation of normal to normal heartbeat intervals)
Time Frame
Impact of game related experience will be measured at baseline
Title
Anxiety - State-Trait Anxiety Inventory
Description
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.
Time Frame
Up to 10 weeks
Title
Game-related experience- Sessions and duration played
Description
During the intervention phase the cognitive training group will play games and will need to log the days and duration played.
Time Frame
Up to 10 weeks
Title
Circadian Rhythm- Morningness-Eveningness Questionnaire
Description
19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.
Time Frame
Up to 10 weeks
Title
Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale
Description
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.
Time Frame
Up to 10 weeks
Title
Subjective Arousal- Arousal Predisposition Scale
Description
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.
Time Frame
Up to 10 weeks
Title
Game Engagement Questionnaire
Description
Questionnaire assessing the experience of the game.
Time Frame
Up to 10 weeks
Title
Mood-Depression-Beck Depression Inventory-II
Description
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.
Time Frame
Up to 10 weeks
Title
Alcohol Use - Alcohol Use Disorder Test
Description
10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
Time Frame
Baseline
Title
Physical Activity - International Physical Activity Questionnaire
Description
7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
Time Frame
Up to 10 weeks
Title
Personality - Big Five Inventory
Description
10 question assessment measuring personality
Time Frame
Baseline
Title
Computer Proficiency- Computer Proficiency Questionnaire
Description
This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Curtis, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be assigned a participant number and de-identified. De-identified data will be shared with other researchers.
Learn more about this trial
Cognitive Training in Mild Cognitive Impairment
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