Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Memory Deficits; Electroconvulsive Therapy	Behavioral: Cognitive Intervention: Memory Training; Behavioral: Comparable general mental stimulation	Not Applicable

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	59 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
Study Start Date :	September 2012
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	May 2017

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Cognitive Intervention: Memory Training; Memory training before and after ECT	Behavioral: Cognitive Intervention: Memory Training; 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 Comparator: Comparable general mental stimulation; Puzzle games before and after ECT	Behavioral: Comparable general mental stimulation; 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.
No Intervention: Treatment as Usual; No memory training or puzzle games, just the study evaluations

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Columbia University Autobiographical Memory Interview-Short Form (AMI-SF) [ Time Frame: 2 months after the last ECT session ]

Secondary Outcome Measures :

1. Goldberg Remote Memory Questionnaire [ Time Frame: 2 months after the last ECT session ]
2. Hamilton Rating Scale for Depression-24 item [ Time Frame: 2 months after the last ECT session ]

Other Outcome Measures:

1. Modified Mini-Mental State examination [ Time Frame: 2 months after the last ECT session ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

Principal Investigator:	Joan Prudic, MD	New York State Psychiatric Institute
Principal Investigator:	Jimmy Choi, PsyD	New York State Psychiatric Institute

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01876758 History of Changes
Other Study ID Numbers:	#6599
First Posted:	June 13, 2013
Last Update Posted:	July 14, 2017
Last Verified:	July 2017

Keywords provided by New York State Psychiatric Institute:

ECT; Memory Training; Cognitive Remediation; Electroconvulsive Therapy; Treatment Resistant Depression	Depression; Geriatric Depression; Memory Loss; Cognitive Training

Additional relevant MeSH terms:

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms