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Cognitive Training in Mild Cognitive Impairment (TRAIN-MCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04899089
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Ashley Curtis, 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.

Condition or disease Intervention/treatment Phase
Insomnia Mild Cognitive Impairment Behavioral: Cognitive Training Behavioral: Trivia Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899089


Contacts
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Contact: Chloe Rzeppa 5738843293 crzeppa@mail.missouri.edu
Contact: Ashley Curtis, PhD 573-884-7487 curtisas@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Chloe Rzeppa    573-884-3293    crzeppa@mail.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Ashley Curtis, PhD University of Missouri-Columbia
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Responsible Party: Ashley Curtis, Assistant Professor of Psychiatry, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04899089    
Other Study ID Numbers: 2053302
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will be assigned a participant number and de-identified. De-identified data will be shared with other researchers.

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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
Keywords provided by Ashley Curtis, University of Missouri-Columbia:
cognitive training
insomnia
mild cognitive impartment
older adults
sleep
cognition
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases