Cognitive Training for Mood and Anxiety Disorders
Primary Purpose
Major Depressive Disorder, Depression, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
emotional memory training exercise
memory training exercise
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring cognitive training, depression, bipolar depression, anxiety, ptsd, generalized anxiety, social phobia
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
emotional memory training exercise
memory training exercise
Arm Description
study training exercise - Emotional Faces Memory Task (EFMT)
an active control exercise (CT)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
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
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
Full Information
NCT ID
NCT02256566
First Posted
October 1, 2014
Last Updated
July 19, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02256566
Brief Title
Cognitive Training for Mood and Anxiety Disorders
Official Title
Cognitive Training for Mood and Anxiety Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 20, 2016 (Actual)
Study Completion Date
April 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
emotional memory training exercise
Arm Type
Experimental
Arm Description
study training exercise - Emotional Faces Memory Task (EFMT)
Arm Title
memory training exercise
Arm Type
Active Comparator
Arm Description
an active control exercise (CT)
Intervention Type
Behavioral
Intervention Name(s)
emotional memory training exercise
Intervention Type
Behavioral
Intervention Name(s)
memory training exercise
Primary Outcome Measure Information:
Title
Proportion of completers to measure feasibility
Description
comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Change in Depression Symptom Severity
Description
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)
Time Frame
baseline and week 6
Title
Change in Anxiety Symptom Severity
Description
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)
Time Frame
baseline and week 6
Title
Change in Negative Affective Bias
Description
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
Time Frame
baseline and week 6
Title
Change in Neurocognition
Description
neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting
Time Frame
baseline and week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Iacoviello, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Cognitive Training for Mood and Anxiety Disorders
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