Assessement of Capacity to Consent

• Conditions: Major Depressive Episode

• Registration Number: NCT04740463
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory.

Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode.

This is a Social and Human Sciences study which does not aim to modify the usual management of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-21
• Primary Completion: 2021-09-01
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Capacity to consent (MacCAT-T)	1 day	aassessment of the capacity to consent based on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T). The questionnaire assesses four competences in consent : understanding (score ranges from 0 to 6), appreciation (score ranges from 0 to 4), reasoning (score ranges from 0 to 8) and expressing a choice (score ranges from 0 to 2).; A low score on each of these dimensions calls into question the patient's ability to consent.

Secondary Outcome Measures

Name	Time	Method
Insight (BCIS)	1 day	insight assessement based on the Beck Cognitive Insight Scale (BCIS). The questionnaire contains two sub-scales : self- reflection (9 items) and self-certainty (6 items). Each items ranges from 0 (do not agree at all) to 3 (agree completely)

Trial Locations

Locations (1)

University hospital; 🇫🇷 Montpellier, France