Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

Electroconvulsive Therapy Clinical Trial

Official title:

Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876758
• Other study ID #: #6599
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: July 13, 2017
• Start date: September 2012
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Electroconvulsive Therapy
• Memory Deficits
• Memory Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Mini-Mental State examination		2 months after the last ECT session
Primary	Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)		2 months after the last ECT session
Secondary	Goldberg Remote Memory Questionnaire		2 months after the last ECT session
Secondary	Hamilton Rating Scale for Depression-24 item		2 months after the last ECT session