Cognitive Fitness for Depression in Older Adults

Mild Cognitive Impairment Clinical Trial

Official title:

Cognitive Remediation of Cognitive Control in Late-Life Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790630
• Other study ID #: 21-046-2
• Secondary ID: 1K23MH118420-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2022
• Source: UConn Health
• Contact: Seyenah Lopez
• Phone: 860-679-6189
• Email: seylopez[@]uchc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators are also interested in whether participating in the treatment will result in changes to brain activity measured with magnetic resonance imaging (MRI).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Depression Mild
• Depressive Disorder
• Depressive Disorder, Major
• Mild Cognitive Impairment

Intervention

Other:
• Computerized Cognitive Remediation of Executive Functioning (CCR-EF)
computerized experimental brain-training treatment
• Active Control
computerized intervention that follows recommendations for cognitive fitness

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in attention / cognitive flexibility as measured by the Trail Making Part B test	time to complete alpha-numeric sequencing	Pre-treatment and six weeks later when treatment has ended
Primary	Change in depression symptom severity as measured with the Montgomery Asberg Depression Rating Scale (MADRS)	depression rating scale	Pre-treatment and six weeks later when treatment has ended
Secondary	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	Pre-treatment and six weeks later when treatment has ended
Secondary	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	Pre-treatment and six weeks later when treatment has ended
Secondary	Change in self-reported depressive symptoms measured with the Carroll Depression Rating Scale	self-report of depression symptoms	Pre-treatment and six weeks later when treatment has ended
Secondary	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	Pre-treatment and six weeks later when treatment has ended