Cognitive Training for Mood and Anxiety Disorders

NCT02256566 | Completed DMC

• 1 other identifier: GCO 14-0994
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Depression Symptom Severity

  baseline and week 6

• Change in Anxiety Symptom Severity

  baseline and week 6

• Change in Negative Affective Bias

  baseline and week 6

• Change in Neurocognition

  baseline and week 6

Study Arms (2)

emotional memory training exercise

EXPERIMENTAL

study training exercise - Emotional Faces Memory Task (EFMT)

Behavioral: emotional memory training exercise

memory training exercise

ACTIVE COMPARATOR

an active control exercise (CT)

Behavioral: memory training exercise

Interventions

emotional memory training exercise BEHAVIORAL

emotional memory training exercise

memory training exercise BEHAVIORAL

memory training exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Bipolar Disorder; Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Phobia, Social; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Phobic Disorders

Study Officials

• Brian Iacoviello, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: September 1, 2014
• Primary Completion: April 20, 2016
• Study Completion: April 20, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)