Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy (COVID-M-ECT)

November 30, 2022 updated by: University Hospital, Ghent

Impact of Covid-19 Pandemic on Patients With Unipolar Depressive Disorder: Effects of Discontinuing Continuation or Maintenance Electroconvulsive Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • East-Flanders
      • Ghent, East-Flanders, Belgium, 9000
        • Ghent University Hospital
    • West-Flanders
      • Kortrijk, West-Flanders, Belgium, 8500
        • Az Groeninge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Questionnaires

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
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.
Other: Questionnaires

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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'.
From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
From time of inclusion until maximum 9 months (or sooner if resumption of ECT)
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.
From time of inclusion until maximum 9 months (or sooner if resumption of ECT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Nele Van de Velde, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2020

Primary Completion (Actual)

June 19, 2020

Study Completion (Actual)

June 19, 2020

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-07543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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