Mild to Moderate Depression. Clinical Trial
Official title:
Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.
Major Depression (MD) is highly prevalent and has associated a high burden and economic
costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).
Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by
NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.
Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC
center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring
(n=150) and B) pharmacological treatment (n=150).
Patients will be followed-up for one year and data will be collected at baseline, 6 and 12
months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life
with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version
of the Client Service Receipt Inventory (including lost productivity).
Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping
replications will be conducted to asses uncertainty. Cost-acceptability curves will be done
using two perspectives: the National Health Service perspective and the Societal
perspective.
The Propensity Score technique will minimize the absence of randomization, matching cases
from both treatment options.
n/a
Observational Model: Case Control, Time Perspective: Prospective