Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy

NCT05633368 | Completed

• 1 other identifier: BC-07543
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Electroconvulsive Therapy; Major Depressive Disorder; Covid-19

Keywords

Electroconvulsive therapy; Maintenance ECT; Continuation ECT; Major depressive disorder; Covid-19

Outcome Measures

Primary Outcomes (5)

• 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.

  From time of inclusion until maximum 9 months (or sooner if resumption of ECT)

Study Arms (2)

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

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

Interventions

Questionnaires OTHER

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; Discontinuation of C/M-ECT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Continuation or maintenance ECT, in treatment at two specified ECT-centers in Belgium
• Unipolar depressive disorder

You may not qualify if:

• Unable to provide informed consent
• Unable to comply with study requirements (telephone questionnaire)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

AZ Groeninge

Kortrijk, West-Flanders, 8500, Belgium

Location

MeSH Terms

Conditions

Depressive Disorder, Major; COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nele Van de Velde

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: December 1, 2022
• Study Start: March 31, 2020
• Primary Completion: June 19, 2020
• Study Completion: June 19, 2020
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)