Clinical trial NCT04790630: Cognitive Fitness for Depression in Older Adults
Official title: Cognitive Remediation of Cognitive Control in Late-Life Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Mild
Depressive Disorder, Major
Mild Cognitive Impairment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-03-10
Enrollment: 138
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in attention / cognitive flexibility as measured by the Trail Making Part B test
timeFrame: Pre-treatment and six weeks later when treatment has ended
measure: Change in depression symptom severity as measured with the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Pre-treatment and six weeks later when treatment has ended
Secondary outcomes:
measure: Change in verbal learning as measured with the California Verbal Learning Test (CVLT) Total Learning
timeFrame: Pre-treatment and six weeks later when treatment has ended
measure: Change in attention processing speed as measured with the Flanker Test of Response Inhibition from the NIH Cognitive Toolbox
timeFrame: Pre-treatment and six weeks later when treatment has ended
measure: Change in self-reported depressive symptoms measured with the Carroll Depression Rating Scale
timeFrame: Pre-treatment and six weeks later when treatment has ended
measure: Change in problem solving/speed/spatial memory as measured with the NIH Toolbox fluid composite scales
timeFrame: Pre-treatment and six weeks later when treatment has ended
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Kevin Manning, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: