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Completed

NCT Number: NCT04790630

Cognitive Fitness for Depression in Older Adults

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).

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Key information

Conditions

Depression Mild Cognition Disorders Cognitive Dysfunction Depressive Disorder Depressive Disorder, Major Mental Disorders Mild Cognitive Impairment Mood Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health

Farmington, Connecticut, 06030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized Cognitive Remediation of Executive Functioning (CCR-EF)

Other

computerized experimental brain-training treatment

Active Control

Other

computerized intervention that follows recommendations for cognitive fitness

Primary outcomes

  1. Trail Making Part B Test

    Time frame: Pre-treatment and six weeks later when treatment has ended

    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.

  2. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Pre-treatment and six weeks later when treatment has ended

    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.

Secondary outcomes

  1. California Verbal Learning Test (CVLT) Total Learning

    Time frame: Pre-treatment and six weeks later when treatment has ended

    Change in verbal learning as measured with the CVLT total learning score. The CVLT learning test includes a 16-item wordlist that is read to the participant five times. So the total possible maximum score on this measure is 80 and the total possible minimum score is 0. The change score is defined as week 6 - baseline, so a positive score indicates improved performance at week 6 compared with baseline.

  2. NIH Toolbox Pattern Comparison Speed Task

    Time frame: Pre-treatment and six weeks later when treatment has ended

    A computerized test of speed of simple processing speed where participants look at two figures and respond as quickly as possible whether those figures are alike or different. Scores are demographic adjusted T scores (adjusted for age, sex, education). T scores have a mean of 50 and a standard deviation of 10. T scores less than 35 indicate impaired performance. A change Score is here defined as Week 6 - Baseline (positive T scores indicate improved performance over the trial). A mean performance of +10 would mean on average that group improved by an entire standard deviation.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Remediation of Cognitive Control in Late-Life Depression

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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