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Electroconvulsive therapy is a safe and effective therapeutic strategy in patients with treatment resistant depression. As relapse after successful ECT is significant even with adequate pharmacological strategies, continuation (up to 6 months after completion of index-ECT) or maintenance ECT (more than 6 months after index-ECT) is often necessary to maintain remission. During the current Covid-19 pandemic hospitals redirected resources and closed or significantly diminished ECT services. In this study we aim to assess the impact of discontinuing maintenance electroconvulsive therapy in patients diagnosed with unipolar depressive disorder.
During the height of the Covid-19 pandemic in Belgium all patients receiving continuation or maintenance electroconvulsive therapy (ECT) for major depressive disorder in two ECT centers in Belgium will be included. Due to differences in Covid-19 infection rates and hospital management decisions, one ECT-service temporarily halted all electroconvulsive treatments, where as the other ECT-service continued continuation and maintenance treatments. Depressive symptomatology and relapse rates will be assessed during the diminished accessibility of electroconvulsive treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation of C/M-ECT | Participants with major depressive disorder who are unable to continue maintenance (M-ECT) or continuation electroconvulsive therapy (C-ECT) due to hospital restrictions during Covid-19 or due to personal preference. |
| |
| Continuation of C/M-ECT | Participants with major depressive disorder who are able to continue maintenance (M-ECT) or continuation electroconvulsive therapy (C-ECT) during Covid-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Participants will be contacted every three weeks to assess depressive symptomatology and possible relapse.
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms (PHQ-9) | Change in depressive symptoms as measured by the patient health questionnaire via phone or through direct participant contact. The PHQ is a 9-question instrument to screen for the presence and severity of depression. The minimum score is 0 and the maximum score is 27, with a higher score indicating more depressive symptoms. | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) |
| Change in depressive symptoms, subjective score, scaling question | Change in depressive symptoms as measured by the following scaling question: How would you rate your depressive symptoms on a scale from 0 to 10 with 0 indicating no depressive symptoms and 10 indicating extremely severe depressive symptoms'. | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) |
| Change in depressive symptoms, subjective score | Change in depressive symptoms as measured by the patient-rated question: 'How would you describe the severity of your depressive symptoms?'. No depressive symptoms equals a score of 0 and severe depressive symptoms equals a score of 3. | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) |
| Change in depressive symptoms (CGI) | Change in depressive symptoms as measured by the Clinical Global impression Scale. This is a clinician-rated scale to assess severity and change in symptomatology with a score of 1 indicating normal or no illness or very much improved and 7 severly ill or very much deteriorated. | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) |
| Relapse, depression | During every study contact the need for restart of electroconvulsive treatment or hospital admission will be evaluated by the investigator. If ECT restart or hospital admission is advised, this will be an indication of relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients receiving continuation or maintenance ECT for unipolar depressieve disorder in two ECT clinics in Belgium at the time of the start of the study (31/03/2020).
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| Name | Affiliation | Role |
|---|---|---|
| Nele Van de Velde | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | East-Flanders | 9000 | Belgium | ||
| AZ Groeninge |
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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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| From time of inclusion until maximum 9 months (or sooner if resumption of ECT) |
| Kortrijk |
| West-Flanders |
| 8500 |
| Belgium |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |