Cognitive Fitness for Depression in Older Adults

Cognitive Remediation of Cognitive Control in Late-Life Depression

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seyenah Lopez; Phone Number: 860-679-6189; Email: seylopez@uchc.edu

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • UConn Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Computerized Cognitive Remediation of Executive Functioning (CCR-EF); computerized experimental brain-training treatment
ACTIVE_COMPARATOR: 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).	Other: Active Control; computerized intervention that follows recommendations for cognitive fitness

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kevin Manning, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2020
• Primary Completion (ANTICIPATED): July 31, 2024
• Study Completion (ANTICIPATED): July 31, 2024

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Depressive Disorder; Cognitive Dysfunction; Depressive Disorder, Major
• Other Study ID Numbers: 21-046-2; 1K23MH118420-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available March 2025
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No