Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01876758
First received: June 3, 2013
Last updated: March 20, 2014
Last verified: June 2013
  Purpose

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 Intervention
Memory Deficits Associated With ECT.
Behavioral: Cognitive Intervention: Memory Training
Behavioral: Comparable general mental stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Columbia University Autobiographical Memory Interview-Short Form (AMI-SF) [ Time Frame: 2 months after the last ECT session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Goldberg Remote Memory Questionnaire [ Time Frame: 2 months after the last ECT session ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression-24 item [ Time Frame: 2 months after the last ECT session ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Modified Mini-Mental State examination [ Time Frame: 2 months after the last ECT session ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

The investigators propose to enroll 60 patients scheduled to undergo ECT over the course of 2 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876758

Contacts
Contact: Joan Prudic, M.D. 646-774-5413 jp33@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Joan Prudic, M.D.    646-774-5413    jp33@columbia.edu   
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

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01876758     History of Changes
Other Study ID Numbers: #6599
Study First Received: June 3, 2013
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

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
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014