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Table 1 World Health Organization Trial Registration Data Set

From: Cognitive remediation following electroconvulsive therapy in patients with treatment resistant depression: randomized controlled trial of an intervention for relapse prevention – study protocol

Data category Information
Primary registry and trial identifying number Clinicaltrials.gov: NCT04383509
Date of registration in primary registry 12 May 2020
Secondary identifying numbers NA
Source(s) of monetary or material support King Baudouin Foundation
Ghent University
University Hospital Ghent
Primary sponsor Ghent University
Secondary sponsor(s) University Hospital Ghent
Contact for public queries Dr. Nele Van de Velde, nele.vandevelde2@uzgent.be
Contact for scientific queries Dr. Nele Van de Velde, nele.vandevelde2@uzgent.be
Public title RCT for Electroconvulsive Treatment Followed by Cognitive Control Training (ECT-CCT)
Scientific title Cognitive remediation following electroconvulsive therapy in patients with treatment resistant depression: randomized controlled trail of an intervention for relapse prevention – Study Protocol
Countries of recruitment Belgium
Health condition(s) or problem(s) studied Depressive relapse following succesful electroconvulsive treatment (ECT)
Cognitive functioning post-ECT
Intervention(s) Active comparator:cognitive control trainingPlacebo comparator: training without focus on cognitive control
Key inclusion and exclusion criteria • Ages eligible for study: ≥18 yearsSexes eligible for study: bothAccepts healthy volunteers: noInclusion criteria: age 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
Study type InterventionalAllocation: randomizedIntervention model: parallel assignmentMasking: double blind (Participant, Outcomes Assessor)Primary purpose: treatment
Date of first enrolment June 2020
Target sample size 88
Recruitment status Recruiting
Primary outcome(s) Change in severity of depressive symptoms, clinician-rated (HAM-D)
Change in severity of depressive symptoms, self-reported (BDI-II)
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
Key secondary outcomes 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
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
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
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
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
Acceptability and satisfaction: Qualitative interviews
Time Frame: 1–30 days after CCT training completion
Time to relapse
Time Frame:Up to 6 months monitoring
Facial features from video footage
Time Frame:2 weeks during CCT or placebo intervention