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Cognitive Fitness for Depression in Older Adults

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ClinicalTrials.gov Identifier: NCT04790630
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kevin Manning, UConn Health

Study Description
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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).

Condition or disease Intervention/treatment Phase
Depression Mild Depressive Disorder, Major Mild Cognitive Impairment Other: Computerized Cognitive Remediation of Executive Functioning (CCR-EF) Other: Active Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Remediation of Cognitive Control in Late-Life Depression
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Computerized Cognitive Remediation of Executive Functioning (CCR-EF) Other: Computerized Cognitive Remediation of Executive Functioning (CCR-EF)
computerized experimental brain-training treatment
Active Comparator: Active Control Other: Active Control
computerized intervention that follows recommendations for cognitive fitness


Outcome Measures
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Primary Outcome Measures :
  1. Change in attention / cognitive flexibility as measured by the Trail Making Part B test [ Time Frame: Pre-treatment and six weeks later when treatment has ended ]
    time to complete alpha-numeric sequencing

  2. Change in depression symptom severity as measured with the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Pre-treatment and six weeks later when treatment has ended ]
    depression rating scale


Secondary Outcome Measures :
  1. Change in verbal learning as measured with the California Verbal Learning Test (CVLT) Total Learning [ Time Frame: Pre-treatment and six weeks later when treatment has ended ]
    number of words recalled over 5 trials and spontaneous semantic organization of those words

  2. Change in attention processing speed as measured with the Flanker Test of Response Inhibition from the NIH Cognitive Toolbox [ Time Frame: Pre-treatment and six weeks later when treatment has ended ]
    computerized test of response inhibition, speed of responding

  3. Change in self-reported depressive symptoms measured with the Carroll Depression Rating Scale [ Time Frame: Pre-treatment and six weeks later when treatment has ended ]
    self-report of depression symptoms

  4. Change in problem solving/speed/spatial memory as measured with the NIH Toolbox fluid composite scales [ Time Frame: Pre-treatment and six weeks later when treatment has ended ]
    computerized picture memory, simple processing speed, problem solving/mental flexibility


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790630


Contacts
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Contact: Muhammad Moazzam 860-679-6189 moazzam@uchc.edu
Contact: Jennifer Brindisi 860-679-7581 brindisi@uchc.edu

Locations
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United States, Connecticut
UConn Health Recruiting
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kevin Manning, Ph.D. UConn Health
More Information
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Responsible Party: Kevin Manning, Associate Professor, UConn Health
ClinicalTrials.gov Identifier: NCT04790630    
Other Study ID Numbers: 21-046-2
1K23MH118420-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available March 2025

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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
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Cognitive Dysfunction
Depressive Disorder, Major
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders