Cognitive Fitness for Depression in Older Adults

NCT04790630 | Completed Results DMC

• 2 other identifiers: 21-046-21K23MH118420-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression Mild; Depressive Disorder, Major; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Trail Making Part B Test

  time to complete alpha-numeric sequencing measured with the Trail Making Test (Part B). Change score is Week 6 - baseline. This is a measure of cognitive processing speed and mental flexibility measured in seconds to complete the task. A participant with a (very) strong performance on this test would complete the test in 25-65 seconds. Completion time is capped at 5 minutes and participants who have not completed the test are assigned a value of 300.

  Pre-treatment and six weeks later when treatment has ended

• Montgomery Asberg Depression Rating Scale (MADRS)

  Change in depression symptom severity as measured with the MADRS depression rating scale. Change score defined as week 6 - baseline (negative values indicate depression has improved). The (MADRS) ranges from 0 to 60, with 10 items scored 0-6 each. Higher scores indicate greater severity. Common cutoff points are: 0-6 (normal/remission), 7-19 (mild), 20-34 (moderate), and 35-60 (severe). Minimal clinically important difference (MCID) measured on the MADRS range from 1.6-1.9.

  Pre-treatment and six weeks later when treatment has ended

Secondary Outcomes (2)

• California Verbal Learning Test (CVLT) Total Learning

  Pre-treatment and six weeks later when treatment has ended

• NIH Toolbox Pattern Comparison Speed Task

  Pre-treatment and six weeks later when treatment has ended

Study Arms (2)

Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

EXPERIMENTAL

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.

Other: Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

Active Control

ACTIVE COMPARATOR

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).

Other: Active Control

Interventions

Active Control OTHER

computerized intervention that follows recommendations for cognitive fitness

Active Control

Computerized Cognitive Remediation of Executive Functioning (CCR-EF) OTHER

computerized experimental brain-training treatment

Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Limitations and Caveats

Limitations include the small sample that was recruited.

Results Point of Contact

• Title: Kevin J Manning
• Organization: University of Connecticut

manning@uchc.edu

860-679-2272

Study Officials

• Kevin Manning, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: March 10, 2021
• Study Start: November 15, 2020
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will be available March 2025

Locations

US (1)