Impact of Covid-19 Pandemic on Patients With Unipolar Depressive Disorder: Effects of Discontinuing Continuation or Maintenance Electroconvulsive Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Change in depressive symptoms, subjective score
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Change in depressive symptoms, subjective score
Time Frame: 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.
Relapse, depression
Time Frame: 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.
Change in depressive symptoms, subjective score, scaling question
Time Frame: 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 (CGI)
Time Frame: 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.
Change in depressive symptoms (PHQ-9)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported