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RCT for Electroconvulsive Treatment Followed by Cognitive Control Training (ECT-CCT)

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ClinicalTrials.gov Identifier: NCT04383509
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
University Hospital, Ghent
King Baudouin Foundation
Information provided by (Responsible Party):
University Ghent

Brief Summary:
Major depressive disorder (MDD) is worldwide one of the most prevalent and disabling mental health conditions. Electroconvulsive therapy (ECT) is a safe and effective treatment even though 6-month relapse rates are high. Cognitive side effects of ECT, such as reduced cognitive control, might trigger mechanisms that increase relapse in patients. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse).

Condition or disease Intervention/treatment Phase
Depressive Episode Electroconvulsive Therapy Cognitive Remediation Behavioral: Cognitive Control Training Behavioral: Active Control Not Applicable

Detailed Description:
Eighty-eight participants aged between 18-70 years with major depressive disorder who start electroconvulsive treatment (ECT) will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), participants will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, participants will be monitored every two weeks for a period of six months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, the investigators will assess participant evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance our understanding of the mechanisms underlying effects of CCT, exploratory analyses may be conducted using facial video footage collected during the CCT/active control phase of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to either intervention or placebo.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Upon registration in the computer-based training, the computer will randomly allocate participants to either cognitive control training or placebo condition.
Primary Purpose: Treatment
Official Title: Cognitive Remediation Following Electroconvulsive Therapy in Patients With Treatment Resistant Depression: Randomized Controlled Trail of an Intervention for Relapse Prevention
Estimated Study Start Date : May 10, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive control training
Cognitive Control Training (CCT) makes use of a very basic cognitive task that strongly loads on working memory and cognitive control processes, namely the adaptive Paced Auditory Serial Addition Task (aPASAT) where participants are given a number every 3 seconds and are asked to add the number they just heard with the number they heard before. Task difficulty is modified based on the participants current task performance, allowing training of cognitive control. Participants in the intervention group will start the CCT training after completion of ECT with a maximum time interval of 7 days. Training sessions will be performed on a tablet or computer and participants will complete five sessions per week (20 minutes per session) for a period of two weeks.
Behavioral: Cognitive Control Training
Cognitive Control Training (CCT) makes use of a very basic cognitive task that strongly loads on working memory and cognitive control processes, namely the adaptive Paced Auditory Serial Addition Task (aPASAT) where participants are given a number every 3 seconds and are asked to add the number they just heard with the number they heard before. Task difficulty is modified based on the participants current task performance, allowing training of cognitive control. Participants in the intervention group will start the CCT training after completion of ECT with a maximum time interval of 7 days. Training sessions will be performed on a tablet or computer and participants will complete five sessions per week (20 minutes per session) for a period of two weeks.
Other Name: aPASAT

Active Comparator: Active Control
Participants in the active control group will start placebo training after completion of ECT with a maximum time interval of 7 days. The placebo task consists of a task similar to the experimental condition but that does not train cognitive control. Prior research confirmed that this condition controls for non-specific effects of the training and motivational issues. Participants will perform the sessions on a tablet or computer and complete five sessions per week (20 minutes per session) for a period of two weeks.
Behavioral: Active Control
Participants in the active control group will start placebo training after completion of ECT with a maximum time interval of 7 days. The placebo task consists of a task similar to the experimental condition but that does not train cognitive control. Prior research confirmed that this condition controls for non-specific effects of the training and motivational issues. Participants will perform the sessions on a tablet or computer and complete five sessions per week (20 minutes per session) for a period of two weeks.




Primary Outcome Measures :
  1. Change in severity of depressive symptoms, clinician-rated (HAM-D) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    The Hamilton Depression Rating Scale (HAM-D) is a clinician rated questionnaire with 17 items scored on a three or five-point Likert-type scale. Amongst other symptoms of depression, items include mood, insomnia and suicidal ideations. Higher scores indicate increased severity of depression with a maximum score of 50 and minimum of 0.

  2. Change in severity of depressive symptoms, self-reported (BDI-II) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    The Beck Depression Inventory (BDI-II) is a 21-item self-report questionnaire regarding symptoms of depression with good validity and reliability. Higher scores indicate increased severity of depression. Minimum score is 0 and 63 is the maximum score.

  3. Change in depressive symptoms and quality of life, self-reported (RDQ) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    The Remission from Depression Questionnaire (RDQ) will inform about seven domains: symptoms of depression, non-depressive symptoms, features of positive mental health, coping ability, functioning, life satisfaction and a general sense of well-being. The RDQ is a 41-item questionnaire. Higher scores indicate increased severity of depression. Minimum score is 0 and 82 is the maximum score.


Secondary Outcome Measures :
  1. Subjective memory complaints (SSMQ) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    To assess subjective cognitive functioning the Dutch version of the Squire Subjective Memory Questionnaire (SSMQ) (Squire, Wetzel et al. 1979) will be administered. this is a self-report questionnaire consisting of 18 items. The patients' answers are scored between -4 (worse than before), 0 (same as before), and +4 (better than before) points, the sum of which are added together to obtain a final score. A negative score shows an increase in the degree of forgetfulness.

  2. Quality of Life in Depression Scale (QLDS) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    This 34-item questionnaire, developed by qualitative interviews, asks patients to rate statements regarding fulfillment of universal human needs such as 'I take good care of myself' and 'I like to know what is going on in the world'.

  3. Rumination (RRS-10) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    The Ruminative Response Scale (RRS-10) will be used to monitor rumination or repetitive negative thinking as this is a well-established cognitive risk factor for major depression. This patient-rated scale consists of 10 items. A higher score indicates a higher degree of rumination with a minimum score of 10 and maximum score of 40.

  4. Cognition (CANTAB) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion ]
    Pattern Recognition Memory (measuring visual pattern recognition memory) and One Touch Stockings of Cambridge (measuring spatial spanning and working memory). A third test, Motor Screening was included to measure general sensorimotor skills.

  5. Cognition (Paced Auditory Serial Addition Task - PASAT) [ Time Frame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion and 6 months after ECT completion ]
    Neuropsychological test to assess capacity and rate of information processing as well as sustained and divided attention.

  6. Acceptability and satisfaction: Qualitative interviews [ Time Frame: 1 - 30 days after CCT training completion ]
    Qualitative interviews will be conducted with a maximum of 20 patients and family members to explore acceptability of the ECT procedure and the intervention.

  7. Time to relapse [ Time Frame: Up to 6 months monitoring ]
    By decreasing depression symptomatology we expect a decrease in relapse rates and a prolonged time-to-relapse-interval as measured by telephone interviews, once every two weeks, in patients who achieve remission.

  8. Facial features from video footage [ Time Frame: 2 weeks during CCT or placebo intervention ]
    During CCT or placebo training facial video footage will be collected from which different facial features will be extracted with the use of automated algorithms. These facial features could give insight into working processes during cognitive training versus placebo training. Certain facial features have shown to be indicative of learning, engagement and depressive symptomatology.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged between 18 and 70 years old
  • current major depressive episode with treatment resistance
  • eligibility and consent for ECT treatment
  • ability to provide consent to study

Exclusion Criteria:

  • neurodegenerative disorder or Montreal Cognitive Assessment (MOCA) < 18
  • catatonia
  • schizophrenia
  • alcohol use disorder in previous year
  • prior ECT treatment
  • insufficient computer knowledge or analphabetism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383509


Contacts
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Contact: Nele Van de Velde +32 9 332 4333 nele.vandevelde2@uzgent.be

Locations
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Belgium
UZ Gent (University Hospital Ghent) Recruiting
Gent, Belgium, 9000
Contact: Nele Van de Velde    +32 9 332 4333    nele.vandevelde2@uzgent.be   
Sponsors and Collaborators
University Ghent
University Hospital, Ghent
King Baudouin Foundation
Investigators
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Study Director: Gilbert Lemmens University Hospital, Ghent
Principal Investigator: Marie-Ann Vanderhasselt University Hospital, Ghent
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04383509    
Other Study ID Numbers: EC/2017/0970
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality issues but are available from the corresponding author upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
Cognitive control training