Cognitive Training for Depression

September 3, 2013 updated by: Icahn School of Medicine at Mount Sinai
This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major depressive disorder (MDD), working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 4 weeks of cognitive training sessions, with two sessions per week.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
  • Age 18-55
  • Able to give informed consent

Exclusion Criteria:

  • A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
  • Visual impairment that would affect the ability to observe the computerized presentation of faces.
  • Motor impairment that would affect the ability to provide a response by quickly pressing a button.
  • Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
  • Primary, current Axis I diagnosis other than Major Depressive Disorder
  • Primary, current Axis II personality disorder.
  • Currently attending a cognitive-behavioral psychotherapy regimen
  • Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
  • Pregnancy in women.

Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (> 8 ounces/day for men and > 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Training A
emotional memory training exercise
Behavioral: Cognitive Training A
Active Comparator: Cognitive Training B
memory training exercise
Behavioral: Cognitive Training B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Hamilton Depression Rating Scale (Ham-D)
Time Frame: baseline and week 4
Change in depression symptom severity at week 4 compared as to baseline
baseline and week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Self-referential Information Processing Task
Time Frame: baseline and week 4
change in Negative Affective Bias at week 4 as compared to baseline
baseline and week 4
change in Working Memory
Time Frame: baseline and week 4
change in Neurocognition at week 4 as compared to baseline
baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Brian M Iacoviello, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 10-0645

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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