Clinical trial NCT02256566: Cognitive Training for Mood and Anxiety Disorders
Official title: Cognitive Training for Mood and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Depression
Bipolar Disorder
Post-traumatic Stress Disorder
Generalized Anxiety Disorder
Social Phobia
Keywords: cognitive training
depression
bipolar depression
anxiety
ptsd
generalized anxiety
social phobia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The objective of this research protocol is to collect feasibility and pilot data investigating the efficacy of a computerized cognitive training paradigm. The training paradigm aims to enhance cognitive control for emotional information-processing and reduce the negative affective biases observed among those experiencing mood and anxiety symptoms and disorders. This protocol will also investigate whether improvements in cognitive control and affective bias are associated with changes in mood and anxiety symptoms. Participants will undergo 6 weeks of cognitive training sessions, with three sessions per week.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of completers to measure feasibility
timeFrame: week 6
Secondary outcomes:
measure: Change in Depression Symptom Severity
timeFrame: baseline and week 6
measure: Change in Anxiety Symptom Severity
timeFrame: baseline and week 6
measure: Change in Negative Affective Bias
timeFrame: baseline and week 6
measure: Change in Neurocognition
timeFrame: baseline and week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Brian Iacoviello, PhD
role: PRINCIPAL_INVESTIGATOR
References: