Computerized Cognitive Remediation for Geriatric Depression

NCT ID: NCT01979289

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-07-31

Brief Summary

This research study will examine if a targeted computerized cognitive remediation (CCR) training program is better for treating geriatric depression than general computer activity. We will also examine whether this intervention is related to improvement in cognitive and depressive symptoms. Elderly patients with depression, who have, and who have not been treated with antidepressant medication for their illness, will be recruited to participate in either a 30 hour cognitive remediation program or general computer activity designed to be both challenging and interesting. They will be asked to complete between 1 and 3 hours of remediation per day over 4 weeks. While undergoing the cognitive remediation participants will be asked questions to assess their symptoms of, as well as the severity of, their depression weekly. This will inform researchers about whether or not the CCR is helping to improve depressive symptoms. At the end of the CCR study, participants will be given a battery of cognitive tests design to tell investigators whether or not the CCR improved their thinking in a variety of different ways including improving attention, memory, and organization. Investigators will also determine whether changes in participants' thinking are related to changes in their mood or other depressive symptoms. It is hoped that information gained from this study will help investigators to better understand the brain processes associated with depression, recovery from depression, and will help inform the development of future alternative treatments for this illness.

Conditions

Major Depressive Disorder; Major Depressive Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Computer Treatment: Active

Computerized Cognitive Remediation: Targeted to underlying cerebral networks associated with remission.

Group Type: EXPERIMENTAL

computerized cognitive remediation

Intervention Type: OTHER

Computer Treatment: Control

Computerized Cognitive Remediation: Non-targeted

Group Type: ACTIVE_COMPARATOR

computerized cognitive remediation:Control

Intervention Type: OTHER

Interventions

computerized cognitive remediation

Intervention Type: OTHER

computerized cognitive remediation:Control

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age: 60-89 years

2. Diagnosis: Major depression, unipolar (by DSM-IV criteria);

3. Severity of depression: MADRS >or =15 following at least 8-weeks of controlled antidepressant treatment.

4. No plans to change current antidepressant treatment.

1. Age: 60-89 years

2. Diagnosis: Major depression, unipolar (by DSM-IV criteria);

3. Severity of depression: MADRS >or =15

4. No antidepressant treatment within the current episode. -

Exclusion Criteria

1. Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS) [47];

2. High suicide risk, i.e. intent or plan to attempt suicide in near future;

3. Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse; Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);

5. Dementia: Mattis Dementia Rating Scale scores below 130 or diagnosis of dementia by DSM-IV; multiple sclerosis, history of head trauma or history of electroconvulsive therapy;

6. Amnestic Mild Cognitive Impairment (a-MCI), or Multiple Domain Mild Cognitive Impairment (md-MCI);

7. Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;

8. Presence of a neurological brain disease and/or history of electroconvulsive therapy;

9. Current involvement in psychotherapy;

10. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion;

11. Inability to speak English;

12. Aphasia;

13. Corrected visual acuity < 20/70; Color blindness -

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Shizuko Morimoto, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

White Plains, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maria Coluccio, M.A.

Role: CONTACT

914-997-4327

Institute of Geriatric Psychiatry

Role: CONTACT

914-997-4331

Other Identifiers

K23MH095830

Identifier Type: NIH

Identifier Source: org_study_id

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