Cognitive Training in Mild Cognitive Impairment

NCT04899089 | Completed

• 1 other identifier: 2053302
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Mild Cognitive Impairment

Keywords

cognitive training; insomnia; mild cognitive impartment; older adults; sleep; cognition

Outcome Measures

Primary Outcomes (5)

• Objective Cognition - Computerized Cognitive Tasks

  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

  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

  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

• 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

• Objective Sleep-Watchpat

  Single night objective sleep recording via a wrist worn device.

  Up to 10 weeks

Secondary Outcomes (12)

• Physiological Arousal- Heart Rate Variability

  Impact of game related experience will be measured at baseline

• Anxiety - State-Trait Anxiety Inventory

  Up to 10 weeks

• Game-related experience- Sessions and duration played

  Up to 10 weeks

• Circadian Rhythm- Morningness-Eveningness Questionnaire

  Up to 10 weeks

• Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale

  Up to 10 weeks

Study Arms (2)

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.

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.

Behavioral: Trivia Training

Interventions

Cognitive Training BEHAVIORAL

The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.

Video Game Training Condition

Trivia Training BEHAVIORAL

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.

Trivia Training Condition

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ashley Curtis, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: July 28, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)