Depression MildNCT04790630
Cognitive Fitness for Depression in Older Adults
A study testing Computerized Cognitive Remediation of Executive Functioning (CCR-EF) in people with Depression Mild and Depressive Disorder, Major, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression Mild, Depressive Disorder, Major, Mild Cognitive Impairment
- What is being tested?
- Computerized Cognitive Remediation of Executive Functioning (CCR-EF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Computerized Cognitive Remediation of Executive Functioning (CCR-EF), Active Control
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Remediation of Executive Functioning (CCR-EF)Other
computerized experimental brain-training treatment
Active ControlOther
computerized intervention that follows recommendations for cognitive fitness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-treatment and six weeks later when treatment has ended
Secondary outcomes (2)
California Verbal Learning Test (CVLT) Total Learning
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.
Measured: Pre-treatment and six weeks later when treatment has ended
NIH Toolbox Pattern Comparison Speed Task
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.
Measured: Pre-treatment and six weeks later when treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Nov 2020
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kevin Manning, UConn Health
- Investigators
- Kevin Manning, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790630
- Sponsor's protocol ID
- 21-046-2
- Other IDs
- 1K23MH118420-01A1
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2021
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation of Cognitive Control in Late-Life Depression
- ClinicalTrials.gov ID
- NCT04790630
- Acronym / sponsor ID
- 21-046-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Remediation of Executive Functioning (CCR-EF) | Experimental | Other: 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. |
| Active Control | Active comparator | Other: Active ControlPatients 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive Remediation of Executive Functioning (CCR-EF)computerized experimental brain-training treatment | Other | Computerized Cognitive Remediation of Executive Functioning (CCR-EF) |
| Active Controlcomputerized intervention that follows recommendations for cognitive fitness | Other | Active Control |
Primary outcome
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.
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.
2 secondary outcomes
California Verbal Learning Test (CVLT) Total Learning
Time frame: Pre-treatment and six weeks later when treatment has ended
NIH Toolbox Pattern Comparison Speed Task
Time frame: Pre-treatment and six weeks later when treatment has ended
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Manning, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Remediation of Executive Functioning (CCR-EF) in people with Depression Mild and Depressive Disorder, Major, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Part B Test (time frame: Pre-treatment and six weeks later when treatment has ended). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.