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Cognitive Fitness for Depression in Older Adults

Primary Purpose

Depression Mild, Depressive Disorder, Major, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Remediation of Executive Functioning (CCR-EF)
Active Control
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression Mild

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UConn HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

Active Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in attention / cognitive flexibility as measured by the Trail Making Part B test
time to complete alpha-numeric sequencing
Change in depression symptom severity as measured with the Montgomery Asberg Depression Rating Scale (MADRS)
depression rating scale

Secondary Outcome Measures

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
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
Change in self-reported depressive symptoms measured with the Carroll Depression Rating Scale
self-report of depression symptoms
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

Full Information

First Posted
January 13, 2021
Last Updated
November 2, 2022
Sponsor
UConn Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04790630
Brief Title
Cognitive Fitness for Depression in Older Adults
Official Title
Cognitive Remediation of Cognitive Control in Late-Life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Depressive Disorder, Major, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computerized Cognitive Remediation of Executive Functioning (CCR-EF)
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Remediation of Executive Functioning (CCR-EF)
Intervention Description
computerized experimental brain-training treatment
Intervention Type
Other
Intervention Name(s)
Active Control
Intervention Description
computerized intervention that follows recommendations for cognitive fitness
Primary Outcome Measure Information:
Title
Change in attention / cognitive flexibility as measured by the Trail Making Part B test
Description
time to complete alpha-numeric sequencing
Time Frame
Pre-treatment and six weeks later when treatment has ended
Title
Change in depression symptom severity as measured with the Montgomery Asberg Depression Rating Scale (MADRS)
Description
depression rating scale
Time Frame
Pre-treatment and six weeks later when treatment has ended
Secondary Outcome Measure Information:
Title
Change in verbal learning as measured with the California Verbal Learning Test (CVLT) Total Learning
Description
number of words recalled over 5 trials and spontaneous semantic organization of those words
Time Frame
Pre-treatment and six weeks later when treatment has ended
Title
Change in attention processing speed as measured with the Flanker Test of Response Inhibition from the NIH Cognitive Toolbox
Description
computerized test of response inhibition, speed of responding
Time Frame
Pre-treatment and six weeks later when treatment has ended
Title
Change in self-reported depressive symptoms measured with the Carroll Depression Rating Scale
Description
self-report of depression symptoms
Time Frame
Pre-treatment and six weeks later when treatment has ended
Title
Change in problem solving/speed/spatial memory as measured with the NIH Toolbox fluid composite scales
Description
computerized picture memory, simple processing speed, problem solving/mental flexibility
Time Frame
Pre-treatment and six weeks later when treatment has ended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyenah Lopez
Phone
860-679-6189
Email
seylopez@uchc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Brindisi
Phone
860-679-7581
Email
brindisi@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Manning, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available March 2025

Learn more about this trial

Cognitive Fitness for Depression in Older Adults

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