Cognitive Training in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— TRAIN-MCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899089
• Other study ID #: 2053302
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Insomnia
• Mild Cognitive Impairment
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Cognition - Computerized Cognitive Tasks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).	Up to 10 weeks
Primary	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
Primary	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
Primary	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
Primary	Objective Sleep-Watchpat	Single night objective sleep recording via a wrist worn device.	Up to 10 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Game Engagement Questionnaire	Questionnaire assessing the experience of the game.	Up to 10 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Personality - Big Five Inventory	10 question assessment measuring personality	Baseline
Secondary	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