Cognitive Training for Mood and Anxiety Disorders

Depression Clinical Trial

Official title:

Cognitive Training for Mood and Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256566
• Other study ID #: GCO 14-0994
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: July 19, 2017
• Start date: September 2014
• Est. completion date: April 20, 2016

Study information

• Verified date: July 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 20, 2016
• Est. primary completion date: April 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Phobic Disorders
• Post-traumatic Stress Disorder
• Social Phobia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• emotional memory training exercise

• memory training exercise

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of completers to measure feasibility	comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers	week 6
Secondary	Change in Depression Symptom Severity	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)	baseline and week 6
Secondary	Change in Anxiety Symptom Severity	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)	baseline and week 6
Secondary	Change in Negative Affective Bias	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	baseline and week 6
Secondary	Change in Neurocognition	neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting	baseline and week 6