Memory DeficitsNCT01876758
Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
A study testing Cognitive Intervention: Memory Training and Comparable general mental stimulation in people with Memory Deficits and Electroconvulsive Therapy, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Memory Deficits, Electroconvulsive Therapy
- What is being tested?
- Cognitive Intervention: Memory Training and Comparable general mental stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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
- Being tested
- Cognitive Intervention: Memory Training, Comparable general mental stimulation
- Keywords
- ECT, Memory Training, Cognitive Remediation, Electroconvulsive Therapy, Treatment Resistant Depression, Depression, Geriatric Depression, Memory Loss, Cognitive Training
- Medical subject headings
- Memory Disorders, Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Intervention: Memory TrainingBehavioural
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 stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Intervention: Memory Training | Experimental | Memory training before and after ECT Receives: Behavioral: Cognitive Intervention: Memory Training |
| Comparable general mental stimulation | Active comparator | Puzzle games before and after ECT Receives: Behavioral: Comparable general mental stimulation |
| Treatment as Usual | No intervention | No memory training or puzzle games, just the study evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)
Measured: 2 months after the last ECT session
Secondary outcomes (2)
Goldberg Remote Memory Questionnaire
Measured: 2 months after the last ECT session
Hamilton Rating Scale for Depression-24 item
Measured: 2 months after the last ECT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DeficitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Prudic, MD, Principal investigator, New York State Psychiatric InstituteJimmy Choi, PsyD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876758
- Sponsor's protocol ID
- #6599
- Status last verified
- Jul 2017
- First submitted
- 3 Jun 2013
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22080239
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT01876758
- Acronym / sponsor ID
- #6599
- Conditions
- Memory Deficits, Electroconvulsive Therapy
- Keywords
- ECT, Memory Training, Cognitive Remediation, Electroconvulsive Therapy, Treatment Resistant Depression, Depression, Geriatric Depression, Memory Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Intervention: Memory Training | Experimental | Behavioral: Cognitive Intervention: Memory TrainingMemory training before and after ECT |
| Comparable general mental stimulation | Active comparator | Behavioral: Comparable general mental stimulationPuzzle games before and after ECT |
| Treatment as Usual | No intervention | –No memory training or puzzle games, just the study evaluations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Intervention: Memory TrainingPaper-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 | Behavioural | Cognitive Intervention: Memory Training |
| Comparable general mental stimulationActive 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. | Behavioural | Comparable general mental stimulation |
Primary outcome
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)
Time frame: 2 months after the last ECT session
2 secondary outcomes
Goldberg Remote Memory Questionnaire
Time frame: 2 months after the last ECT session
Hamilton Rating Scale for Depression-24 item
Time frame: 2 months after the last ECT session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Background: PubMed 22080239Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Prudic, MD principal investigator
New York State Psychiatric Institute
Jimmy Choi, PsyD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Intervention: Memory Training and Comparable general mental stimulation in people with Memory Deficits and Electroconvulsive Therapy, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF) (time frame: 2 months after the last ECT session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.