Cognitive Fitness for Depression in Older Adults

Not Applicable

Active, not recruiting

• Conditions: Depressive Disorder, Major; Mild Cognitive Impairment; Depression Mild
• Interventions: Other: Active Control; Other: Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

• Registration Number: NCT04790630
• Lead Sponsor: UConn Health

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-11-15
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control	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).
Computerized Cognitive Remediation of Executive Functioning (CCR-EF)	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.

Primary Outcome Measures

Name	Time	Method
Change in depression symptom severity as measured with the Montgomery Asberg Depression Rating Scale (MADRS)	Pre-treatment and six weeks later when treatment has ended	depression rating scale
Change in attention / cognitive flexibility as measured by the Trail Making Part B test	Pre-treatment and six weeks later when treatment has ended	time to complete alpha-numeric sequencing

Secondary Outcome Measures

Name	Time	Method
Change in problem solving/speed/spatial memory as measured with the NIH Toolbox fluid composite scales	Pre-treatment and six weeks later when treatment has ended	computerized picture memory, simple processing speed, problem solving/mental flexibility
Change in self-reported depressive symptoms measured with the Carroll Depression Rating Scale	Pre-treatment and six weeks later when treatment has ended	self-report of depression symptoms
Change in verbal learning as measured with the California Verbal Learning Test (CVLT) Total Learning	Pre-treatment and six weeks later when treatment has ended	number of words recalled over 5 trials and spontaneous semantic organization of those words
Change in attention processing speed as measured with the Flanker Test of Response Inhibition from the NIH Cognitive Toolbox	Pre-treatment and six weeks later when treatment has ended	computerized test of response inhibition, speed of responding

Trial Locations

Locations (1)

UConn Health; 🇺🇸 Farmington, Connecticut, United States