Cognitive Training for Depression

Study Overview
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Brief Summary
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This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

Detailed Description
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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.

Official Title
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Cognitive Training for Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Cognitive Training A
* Behavioral: Cognitive Training B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training A<br>emotional memory training exercise | Behavioral: Cognitive Training A<br> <br> |
| Active Comparator: Cognitive Training B<br>memory training exercise | Behavioral: Cognitive Training B<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Hamilton Depression Rating Scale (Ham-D) | 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 | change in Negative Affective Bias at week 4 as compared to baseline | baseline and week 4 | 
| change in Working Memory | change in Neurocognition at week 4 as compared to baseline | baseline and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive training, Depression