Depression Mild, Depressive Disorder, Major, Mild Cognitive Impairment
Conditions
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.
Interventions
OTHERComputerized Cognitive Remediation of Executive Functioning (CCR-EF)
computerized experimental brain-training treatment
OTHERActive Control
computerized intervention that follows recommendations for cognitive fitness
Sponsors
UConn Health
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trail Making Part B Test | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| California Verbal Learning Test (CVLT) Total Learning | 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. |
| NIH Toolbox Pattern Comparison Speed Task | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKevin Manning, Ph.D.
UConn Health
Participant flow
Recruitment details
Recruitment of subjects was carried out by several mechanisms, including: A) Referral from the psychiatry outpatient clinic, the geriatric medicine clinic at UCHC, and geriatricians in the community. Additional recruitment methods included community talks where participation in the research study was offered; distribution of flyers to include community housing, churches, organizations, medical clinics, and community centers; and advertising in newspapers, magazines, etc.
Pre-assignment details
We used a comprehensive cognitive battery to classify patients as cognitively normal (CN), mild cognitive impairment (MCI), or excluded due to dementia.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 18 |
| other Total, other adverse events | 0 / 15 | 0 / 18 |
| serious Total, serious adverse events | 1 / 15 | 0 / 18 |
Outcome results
None listed