Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

NCT ID: NCT01876758

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-05-31

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.

Conditions

Memory Deficits; Electroconvulsive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cognitive Intervention: Memory Training

Memory training before and after ECT

Group Type: EXPERIMENTAL

Cognitive Intervention: Memory Training

Intervention Type: BEHAVIORAL

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

Comparable general mental stimulation

Puzzle games before and after ECT

Group Type: ACTIVE_COMPARATOR

Comparable general mental stimulation

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

No memory training or puzzle games, just the study evaluations

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Prudic, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Jimmy Choi, PsyD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22080239 (View on PubMed)

Other Identifiers

#6599

Identifier Type: -

Identifier Source: org_study_id