Covid-19, Electroconvulsive Therapy, Major Depressive Disorder
Conditions
Keywords
Electroconvulsive therapy, Maintenance ECT, Continuation ECT, Major depressive disorder, Covid-19
Brief summary
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.
Detailed description
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.
Interventions
OTHERQuestionnaires
Participants will be contacted every three weeks to assess depressive symptomatology and possible relapse. * Patient Health Questionnaire (PHQ-9) * Clinical Global Impression (CGI) * Scaling question regarding depressive symptomatology
Sponsors
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Continuation or maintenance ECT, in treatment at two specified ECT-centers in Belgium * Unipolar depressive disorder
Exclusion criteria
* Unable to provide informed consent * Unable to comply with study requirements (telephone questionnaire)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms (PHQ-9) | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) | 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. |
| Change in depressive symptoms, subjective score, scaling question | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) | 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'. |
| Change in depressive symptoms, subjective score | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) | 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. |
| Change in depressive symptoms (CGI) | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) | 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. |
| Relapse, depression | From time of inclusion until maximum 9 months (or sooner if resumption of ECT) | 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. |
Countries
Belgium
Outcome results
None listed