Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
Primary Purpose
Memory Deficits, Electroconvulsive Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Intervention: Memory Training
Comparable general mental stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Memory Deficits focused on measuring ECT, Memory Training, Cognitive Remediation, Electroconvulsive Therapy, Treatment Resistant Depression, Depression, Geriatric Depression, Memory Loss, Cognitive Training
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Major Depressive Disorder
- Inpatient at NYSPI or Presbyterian Hospital
- Scheduled to undergo right-unilateral electroconvulsive therapy in the next two weeks
- We do not require participants to be psychiatrically stable in terms of their symptoms. They only need to demonstrate capacity to consent and be willing to sit through 3 training sessions prior to ECT and 5 sessions post ECT
Exclusion Criteria:
- Significant auditory/visual impairment that would interfere with study procedures
- Lack of aptitude in English that may interfere with the administration of the tests
- Changes in the type of antidepressant during the course of ECT or 2 weeks post ECT
- Chart diagnosis of any other medical or neuropsychiatric illnesses known to impair brain function (e.g. mental retardation, traumatic brain injury, schizophrenia)
- History of ECT in past 2 months
- Mental status examination score below 40/57
- Current substance abuse (e.g. marijuana or crack), excluding nicotine and caffeine.
- Too agitated to sit through the required tests or training
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Cognitive Intervention: Memory Training
Comparable general mental stimulation
Treatment as Usual
Arm Description
Memory training before and after ECT
Puzzle games before and after ECT
No memory training or puzzle games, just the study evaluations
Outcomes
Primary Outcome Measures
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)
Secondary Outcome Measures
Goldberg Remote Memory Questionnaire
Hamilton Rating Scale for Depression-24 item
Full Information
NCT ID
NCT01876758
First Posted
June 3, 2013
Last Updated
July 13, 2017
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT01876758
Brief Title
Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
Official Title
Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although electroconvulsive therapy (ECT) remains the most effective treatment for people with severe depression, patients may experience a significant degree of persistent and/or permanent memory problems following ECT. Many patients report the memory problems are the most disturbing and serious side effect of ECT, and that such effects impact their quality of life following treatment and their willingness to consent to further ECT needed to complete a treatment course or to maintain remission. New developments in the field of cognitive remediation have demonstrated the benefits of cognitive training to improve memory performance in various conditions, such as epilepsy. However, these strategies have never been applied to help patients regain memory after ECT. The investigators have designed and piloted a novel cognitive program specifically targeted to the cognitive effects of ECT, based upon a program tailored to people with seizure disorders, a group with memory problems very similar to people who undergo ECT. This Memory Training for ECT (Mem-ECT) is designed to help cognitive functions that may be compromised following ECT remain relatively preserved. In addition, the intervention attempts to help ECT patients quickly regain their general memory skills immediately following ECT. Recent results from our preliminary group of patients who underwent ECT and memory training at New York Presbyterian shows no overall decline in memory function following ECT. On the basis of these promising findings, the investigators propose a more rigorous and larger study to confirm whether this novel memory training program can help alleviate memory problems associated with ECT.
Detailed Description
The investigators propose to enroll 60 patients scheduled to undergo ECT over the course of 3 years. They will be randomly assigned to one of three research conditions (a) participants in Mem-ECT condition will receive memory training before and after their ECT course, (b) participants in the active control condition will work on commercially available puzzle games at the same times prior and after ECT to determine if the developed memory training program is more effective than mere mental stimulation, (c) participants in the "treatment as usual" will not work on the memory training or the puzzle games but just undergo the study evaluations. Participants will be evaluated a few days before ECT, within 2 weeks following ECT, and once again 2 months later. The evaluation will consist of interviews, mental skill testing, and measuring brain waves using an electroencephalograph (EEG) before ECT and 2 months after ECT (no EEG right after ECT). It is our hope that developing a safe and effective strategy to minimize the adverse memory side effects of ECT will make ECT a better and more easily tolerated treatment for patients with severe depression who need this therapeutic option.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Deficits, Electroconvulsive Therapy
Keywords
ECT, Memory Training, Cognitive Remediation, Electroconvulsive Therapy, Treatment Resistant Depression, Depression, Geriatric Depression, Memory Loss, Cognitive Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Intervention: Memory Training
Arm Type
Experimental
Arm Description
Memory training before and after ECT
Arm Title
Comparable general mental stimulation
Arm Type
Active Comparator
Arm Description
Puzzle games before and after ECT
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
No memory training or puzzle games, just the study evaluations
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Intervention: Memory Training
Intervention Description
Paper-and-pencil and computerized exercises pre- and post-ECT which may be helpful in recovering episodic memories and allow for the retention of learned strategies
Intervention Type
Behavioral
Intervention Name(s)
Comparable general mental stimulation
Intervention Description
Active control will work on commercially available puzzle games at the same time prior and after ECT to determine if the developed memory training program is more effective than mere mental stimulation.
Primary Outcome Measure Information:
Title
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)
Time Frame
2 months after the last ECT session
Secondary Outcome Measure Information:
Title
Goldberg Remote Memory Questionnaire
Time Frame
2 months after the last ECT session
Title
Hamilton Rating Scale for Depression-24 item
Time Frame
2 months after the last ECT session
Other Pre-specified Outcome Measures:
Title
Modified Mini-Mental State examination
Time Frame
2 months after the last ECT session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Major Depressive Disorder
Inpatient at NYSPI or Presbyterian Hospital
Scheduled to undergo right-unilateral electroconvulsive therapy in the next two weeks
We do not require participants to be psychiatrically stable in terms of their symptoms. They only need to demonstrate capacity to consent and be willing to sit through 3 training sessions prior to ECT and 5 sessions post ECT
Exclusion Criteria:
Significant auditory/visual impairment that would interfere with study procedures
Lack of aptitude in English that may interfere with the administration of the tests
Changes in the type of antidepressant during the course of ECT or 2 weeks post ECT
Chart diagnosis of any other medical or neuropsychiatric illnesses known to impair brain function (e.g. mental retardation, traumatic brain injury, schizophrenia)
History of ECT in past 2 months
Mental status examination score below 40/57
Current substance abuse (e.g. marijuana or crack), excluding nicotine and caffeine.
Too agitated to sit through the required tests or training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Prudic, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jimmy Choi, PsyD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22080239
Citation
Choi J, Lisanby SH, Medalia A, Prudic J. A conceptual introduction to cognitive remediation for memory deficits associated with right unilateral electroconvulsive therapy. J ECT. 2011 Dec;27(4):286-91. doi: 10.1097/YCT.0b013e31821d3ab3.
Results Reference
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Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
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