Cognitive Fitness for Depression in Older Adults

NCT ID: NCT04790630

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2024-10-15

Brief Summary

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This research is being done to determine if computerized administered cognitive fitness activities will improve thinking and depression in older depressed adults who are being treated with antidepressants. The investigators are also interested in whether participating in the treatment will result in changes to brain activity measured with magnetic resonance imaging (MRI).

Detailed Description

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Major depression in the elderly is both challenging to treat and detrimental to the cognitive functioning of patients. Major depression increases the probability of a later dementia diagnosis. By targeting cognitive processes in treatment, the investigators hope to both find a more effective means to manage major depression in older adults, but also demonstrate how top-down processes (e.g., Executive Control Network) may be driving depression and cognitive decline in older adults.

The investigators are recruiting older adults with and without mild cognitive impairment. All subjects must have at least mild depressive symptoms to be eligible to participate. Subjects will be randomly assigned to one of two different interventions.

Results of this study will help the investigators understand the mechanisms that contribute to depressed mood and cognitive change in older adults with late life depression.

Conditions

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Depression Mild Depressive Disorder, Major Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

Initially 10 hours of processing speed exercises from "Brain HQ", (the 3 exercises are auditory tone sweep, visual processing \[Double Decision\], visual sweep).

Following the 8-10 hours of Brain HQ, participants complete 8-10 hours of "Ultimate Word Master" before completing 16-20 hours of "Neurogrow" (formerly called "Catch the Ball").

Participants are asked to complete approximately 28-42 hours of computerized brain training over 4-6 weeks.

Group Type EXPERIMENTAL

Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

Intervention Type OTHER

computerized experimental brain-training treatment

Active Control

Patients in the active control arm will complete three activities according to a standard protocol: 1) play a visuospatially oriented computer game (Myst), 2) watch computer-based educational programs on art, history, literature, and 3) play computer games online through the Brain HQ platform; games include crossword puzzles, soduko, paddleboard, and word search. Participants will complete a total of 32-42 hours of training over 4-6 weeks. Time spent on each task will be evenly divided (15 minutes of each task everday).

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type OTHER

computerized intervention that follows recommendations for cognitive fitness

Interventions

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Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

computerized experimental brain-training treatment

Intervention Type OTHER

Active Control

computerized intervention that follows recommendations for cognitive fitness

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ability to read and write in English
* current major or mild depression despite ongoing treatment
* under the care of a physician who prescribes medication for depression
* currently treated with an antidepressant for at least 8 weeks

Exclusion Criteria

* psychosis
* other psychiatric disorders (except personality \& generalized anxiety disorders)
* substance use disorders in the prior year
* clinical diagnosis of dementia
* neurological disorders (e.g., stroke, epilepsy, brain injury with loss of consciousness \> 30 minutes, brain tumors, demyelinating diseases)
* corrected visual acuity \< 20/70 or color blindness
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Kevin Manning

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Manning, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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UConn Health

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1K23MH118420-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-046-2

Identifier Type: -

Identifier Source: org_study_id

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