Table 1 World Health Organization Trial Registration Data Set
Data category | Information |
|---|---|
Primary registry and trial identifying number | |
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 |