Cognitive Training for Mood and Anxiety Disorders

Completed · Not applicable

Conditions studied: Major Depressive Disorder, Depression, Bipolar Disorder, Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Social Phobia

In brief

The purpose of this study is to investigate the effects of a computerized cognitive training program (an attention and memory exercise performed on a computer) on thinking and memory in individuals with mood and anxiety disorders, and to begin to test whether this training affects symptoms of depression or anxiety.

Key facts

Study ID: NCT02256566
Run by: Icahn School of Medicine at Mount Sinai
People needed: 28
Starts: 2014-09-01
Expected to finish: 2016-04-20
Last updated by the study team: 2017-07-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Primary, current Axis I diagnosis of a mood disorder (e.g., major depressive disorder (MDD); bipolar disorder, currently depressed) or anxiety disorder (PTSD; Generalized Anxiety Disorder (GAD); Social Phobia) according to DSM-IV criteria and SCID-IV diagnosis OR must be free of any psychiatric condition (for the healthy volunteer group)
Age 18-80
Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process

You may not qualify if…

A history of drug or alcohol abuse or dependence (DSM-IV criteria) within the previous 6 months
Visual impairment that would affect the ability to observe the computerized exercises
Motor impairment that would affect the ability to provide a response by quickly pressing a button
Patients with mood congruent or mood incongruent psychotic features
Primary, current Axis I diagnosis other than MDD, Bipolar Disorder (currently depressed), PTSD, GAD or Social Phobia
The presence of axis II personality disorder psychopathology that, in the opinion of the investigator, will interfere with study participation
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. A urine pregnancy test will be administered at screening
Enrolled participants can be currently taking standard antidepressant or mood stabilizer medication regimens, or benzodiazepine treatment for sleep as needed but not exceeding 3 nights per week. Medication regimens must be stable at the time of study enrollment (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). No medications will be started or discontinued for the purpose of enrollment into the study
Subjects must exhibit no or only moderate alcohol use during study participation. Subjects with current excessive use of alcohol (> 8 ounces/day) or participants abusing substances will be ineligible for participation, as such drug use could confound the results. A urine toxicology test will be administered at screening to test for drugs of abuse
Participants exhibiting depression symptoms in the severe range (Ham-D > 27) will be excluded from participation as an investigational study such as this may not be suitable
Participants exhibiting chronic MDD episodes (defined as a current episode lasting 5+ years) will be excluded from participation as an investigational study such as this may not be suitable

Where it is running

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

Full record on ClinicalTrials.gov

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