Cognitive Training for Mood and Anxiety Disorders

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT02256566

Collaborator

(none)

Enrollment

Location

Arms

19.6

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Depression Bipolar Disorder Post-traumatic Stress Disorder Generalized Anxiety Disorder Social Phobia	Behavioral: emotional memory training exercise Behavioral: memory training exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cognitive Training for Mood and Anxiety Disorders

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Apr 20, 2016

Actual Study Completion Date :

Apr 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: emotional memory training exercise study training exercise - Emotional Faces Memory Task (EFMT)	Behavioral: emotional memory training exercise
Active Comparator: memory training exercise an active control exercise (CT)	Behavioral: memory training exercise

Arm

Intervention/Treatment

Experimental: emotional memory training exercise

study training exercise - Emotional Faces Memory Task (EFMT)

Behavioral: emotional memory training exercise

Active Comparator: memory training exercise

an active control exercise (CT)

Behavioral: memory training exercise

Outcome Measures

Primary Outcome Measures

Proportion of completers to measure feasibility [week 6]
comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers

Secondary Outcome Measures

Change in Depression Symptom Severity [baseline and week 6]
Depression symptom severity comparison at week 6 to baseline as measured by the Hamilton Depression Rating Scale (Ham-D) and Quick Inventory of Depressive Symptoms (QIDS-C)
Change in Anxiety Symptom Severity [baseline and week 6]
Anxiety symptom severity comparison at week 6 to baseline as measured by the Hamilton Anxiety Rating Scale (Ham-A) and Treatment Outcome PTSD Scale (TOP-8)
Change in Negative Affective Bias [baseline and week 6]
Negative affective bias comparison at week 6 to baseline as measured by the Self-referential Information Processing Task, Affective Go/No-Go, Emotional Stroop, Emotion Faces Recognition Task, Cognitive Style Questionnaire, Ruminative Responses Scale, and Attention Bias Variability Task
Change in Neurocognition [baseline and week 6]
neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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