Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.
Rationale: Currently, detailed information on the cost-effectiveness of ECT based on real-world data is lacking, as well as the comparative cost-effectiveness with respect to medication. Reliable information on outcomes of ECT in comparison with antidepressant treatment and its cognitive side-effects is needed for patients and clinicians to make a balanced and shared decision regarding choosing or refraining from ECT. Objective: Primary Objective: determine (cost)-effectiveness of ECT compared to medication by determining the impact of treatment for MDD with ECT or TCA on remission rates using a one-year time horizon (trial-based economic evaluation) Secondary Objective: determine side-effects of ECT compared to medication by determining the impact of treatment with ECT or medication on side-effects and quality of life during a one-year follow-up Study design: Observational, parallel inception cohort study of patients who will undergo standard clinical care according to current guidelines. Study population: 110 patients (\>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT (ECT group) and 110 patients (\>18 yrs.) with a depressive episode (unipolar MDD) who will undergo treatment with antidepressants will be recruited from specialized clinics (academic hospital, general hospital and GGz-institute) and followed-up for one year to gather reliable data on efficacy including relapse rates, cost-effectiveness, quality of life and cognitive functioning.
Study Type
OBSERVATIONAL
Enrollment
220
ECT
GGz inGeest
Amsterdam, Netherlands
RECRUITINGRadboudUMC
Nijmegen, Netherlands
RECRUITINGEffectiveness of treatment as measured by reduction on HDRS-17
Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)
Time frame: change from baseline at 3 months, 6 months and 12 months
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
Time frame: change from baseline at 3 months, 6 months and 12 months
Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
Time frame: change from baseline at 3 months, 6 months and 12 months
Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
Time frame: change from baseline at 3 months, 6 months and 12 months
COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)
Time frame: change from baseline at 3 months, 6 months and 12 months
Subjective Assessment of Memory Impairment (SAMI)
Subjective Assessment of Memory Impairment (SAMI)
Time frame: change from baseline at 3 months, 6 months and 12 months
15 words test (15WT)
(15WT; Saan \& Deelman, 1986)
Time frame: change from baseline at 3 months, 6 months and 12 months
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Verbal fluency test (e.g., Lezak et al., 2012).
It typically consists of two tasks: category fluency (sometimes called semantic fluency; Benton, 1968) and letter fluency (sometimes called phonemic fluency; Newcombe, 1969). participants are given 1 min to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency).
Time frame: change from baseline at 3 months, 6 months and 12 months