Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01876758

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Memory Deficits Electroconvulsive Therapy	Behavioral: Cognitive Intervention: Memory Training Behavioral: Comparable general mental stimulation	N/A

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

Study Type:

Interventional

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 :

Sep 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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 Outcome Measures

Modified Mini-Mental State examination [2 months after the last ECT session]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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