Computerized Cognitive Remediation for Geriatric Depression

NCT01979289 | Unknown DMC

• 1 other identifier: K23MH095830
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Executive Dysfunction; Cognitive Remediation; Geriatric; Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  10 item measure to assess the core symptoms and cognitive features of clinical depression

  4-6 weeks

Study Arms (2)

Computer Treatment: Active

EXPERIMENTAL

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

Other: computerized cognitive remediation

Computer Treatment: Control

ACTIVE COMPARATOR

Computerized Cognitive Remediation: Non-targeted

Other: computerized cognitive remediation:Control

Interventions

computerized cognitive remediation OTHER

Computer Treatment: Active

computerized cognitive remediation:Control OTHER

Computer Treatment: Control

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 60-89 years
• Diagnosis: Major depression, unipolar (by DSM-IV criteria);
• Severity of depression: MADRS \>or =15 following at least 8-weeks of controlled antidepressant treatment.
• No plans to change current antidepressant treatment.
• Age: 60-89 years
• Diagnosis: Major depression, unipolar (by DSM-IV criteria);
• Severity of depression: MADRS \>or =15
• No antidepressant treatment within the current episode. -

You may not qualify if:

• 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) \[47\];
• High suicide risk, i.e. intent or plan to attempt suicide in near future;
• 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);
• 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;
• Amnestic Mild Cognitive Impairment (a-MCI), or Multiple Domain Mild Cognitive Impairment (md-MCI);
• 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;
• Presence of a neurological brain disease and/or history of electroconvulsive therapy;
• Current involvement in psychotherapy;
• Inability to speak English;
• Aphasia;
• Corrected visual acuity \< 20/70; Color blindness -

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

White Plains, New York, 10605, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sarah Shizuko Morimoto, Psy.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Coluccio, M.A.

CONTACT

914-997-4327

Institute of Geriatric Psychiatry

CONTACT

914-997-4331

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 8, 2013
• Study Start: August 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

US (1)