Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJuly 14, 2017
July 1, 2017
2.9 years
June 3, 2013
July 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)
2 months after the last ECT session
Secondary Outcomes (2)
Goldberg Remote Memory Questionnaire
2 months after the last ECT session
Hamilton Rating Scale for Depression-24 item
2 months after the last ECT session
Other Outcomes (1)
Modified Mini-Mental State examination
2 months after the last ECT session
Study Arms (3)
Cognitive Intervention: Memory Training
EXPERIMENTALMemory training before and after ECT
Comparable general mental stimulation
ACTIVE COMPARATORPuzzle games before and after ECT
Treatment as Usual
NO INTERVENTIONNo memory training or puzzle games, just the study evaluations
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 22080239BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan Prudic, MD
New York State Psychiatric Institute
- PRINCIPAL INVESTIGATOR
Jimmy Choi, PsyD
New York State Psychiatric Institute
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
June 3, 2013
First Posted
June 13, 2013
Study Start
September 1, 2012
Primary Completion
August 1, 2015
Study Completion
May 1, 2017
Last Updated
July 14, 2017
Record last verified: 2017-07