InsomniaTRAIN-MCINCT04899089
Cognitive Training in Mild Cognitive Impairment
A study testing Cognitive Training and Trivia Training in people with Insomnia and Mild Cognitive Impairment, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia, Mild Cognitive Impairment
- What is being tested?
- Cognitive Training and Trivia Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Insomnia, Mild Cognitive Impairment
- Being tested
- Cognitive Training, Trivia Training
- Keywords
- cognitive training, insomnia, mild cognitive impartment, older adults, sleep, cognition
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
Trivia TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video Game Training Condition | Experimental | Participants complete an 8 week long computerized cognitive training intervention. Participants play the games for 45 minutes, three times per week. Receives: Behavioral: Cognitive Training |
| Trivia Training Condition | Active comparator | Participants complete an 8 week long computerized trivia training. Participants complete the trivia training for 45 minutes, three times per week. Receives: Behavioral: Trivia Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 days
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.
Measured: Up to 10 weeks
Objective Sleep-Watchpat
Single night objective sleep recording via a wrist worn device.
Measured: Up to 10 weeks
Secondary outcomes (12)
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)
Measured: Impact of game related experience will be measured at baseline
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
Game Engagement Questionnaire
Questionnaire assessing the experience of the game.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Baseline
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.
Measured: Up to 10 weeks
Personality - Big Five Inventory
10 question assessment measuring personality
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start28 Jul 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Curtis, University of Missouri-Columbia
- Investigators
- Ashley Curtis, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899089
- Sponsor's protocol ID
- 2053302
- Acronym
- TRAIN-MCI
- Status last verified
- Oct 2023
- First submitted
- 19 May 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be assigned a participant number and de-identified. De-identified data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal
- ClinicalTrials.gov ID
- NCT04899089
- Acronym / sponsor ID
- TRAIN-MCI / 2053302
- Conditions
- Insomnia, Mild Cognitive Impairment
- Keywords
- cognitive training, insomnia, mild cognitive impartment, older adults, sleep, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Game Training Condition | Experimental | Behavioral: Cognitive TrainingParticipants complete an 8 week long computerized cognitive training intervention. Participants play the games for 45 minutes, three times per week. |
| Trivia Training Condition | Active comparator | Behavioral: Trivia TrainingParticipants complete an 8 week long computerized trivia training. Participants complete the trivia training for 45 minutes, three times per week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingThe computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills. | Behavioural | Video Game Training Condition |
| Trivia TrainingThe 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. | Behavioural | Trivia Training Condition |
Primary outcome
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).
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.
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.
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.
Objective Sleep-Watchpat
Time frame: Up to 10 weeks
Single night objective sleep recording via a wrist worn device.
12 secondary outcomes
Physiological Arousal- Heart Rate Variability
Time frame: Impact of game related experience will be measured at baseline
Anxiety - State-Trait Anxiety Inventory
Time frame: Up to 10 weeks
Game-related experience- Sessions and duration played
Time frame: Up to 10 weeks
Circadian Rhythm- Morningness-Eveningness Questionnaire
Time frame: Up to 10 weeks
Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale
Time frame: Up to 10 weeks
Subjective Arousal- Arousal Predisposition Scale
Time frame: Up to 10 weeks
Game Engagement Questionnaire
Time frame: Up to 10 weeks
Mood-Depression-Beck Depression Inventory-II
Time frame: Up to 10 weeks
Alcohol Use - Alcohol Use Disorder Test
Time frame: Baseline
Physical Activity - International Physical Activity Questionnaire
Time frame: Up to 10 weeks
Personality - Big Five Inventory
Time frame: Baseline
Computer Proficiency- Computer Proficiency Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No. Participant data will be assigned a participant number and de-identified. De-identified data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Curtis, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and Trivia Training in people with Insomnia and Mild Cognitive Impairment, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Cognition - Computerized Cognitive Tasks (time frame: Up to 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.