search
Back to results

Cognitive Training for Depression II

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training A
Cognitive Training B
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Cognitive training, Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason.
  • Enrolled participants can be currently taking medication but must be stabilized on their medication regimens before enrolling in the study (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). Accordingly, if a patient's medication status must change during the course of the study, we will discontinue them in the study. We do not anticipate that this will occur frequently, as again, patients' medication regimens must be stable before enrolling in the study. No medications will be discontinued for the purpose of enrollment into the study.

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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Training A

Cognitive Training B

Arm Description

emotional memory training exercise

memory training exercise

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (Ham-D)
Depression symptom severity comparison at week 6 to baseline

Secondary Outcome Measures

Negative Affective Bias
scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop
Negative Affective Bias
scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop
Negative Affective Bias
scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop
Working Memory
Neurocognition
Working Memory
Neurocognition
Working Memory
Neurocognition

Full Information

First Posted
August 29, 2013
Last Updated
July 19, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01934491
Brief Title
Cognitive Training for Depression II
Official Title
A Novel Cognitive Training Intervention for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
May 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.
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 MDD, working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 6 weeks of cognitive training sessions, with three sessions per week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Cognitive training, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training A
Arm Type
Experimental
Arm Description
emotional memory training exercise
Arm Title
Cognitive Training B
Arm Type
Active Comparator
Arm Description
memory training exercise
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training A
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training B
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (Ham-D)
Description
Depression symptom severity comparison at week 6 to baseline
Time Frame
baseline and week 6
Secondary Outcome Measure Information:
Title
Negative Affective Bias
Description
scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop
Time Frame
baseline
Title
Negative Affective Bias
Description
scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop
Time Frame
week 3
Title
Negative Affective Bias
Description
scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop
Time Frame
week 6
Title
Working Memory
Description
Neurocognition
Time Frame
baseline
Title
Working Memory
Description
Neurocognition
Time Frame
week 3
Title
Working Memory
Description
Neurocognition
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason. Enrolled participants can be currently taking medication but must be stabilized on their medication regimens before enrolling in the study (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). Accordingly, if a patient's medication status must change during the course of the study, we will discontinue them in the study. We do not anticipate that this will occur frequently, as again, patients' medication regimens must be stable before enrolling in the study. No medications will be discontinued for the purpose of enrollment into the study. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Iacoviello, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Training for Depression II

We'll reach out to this number within 24 hrs