NCT02245373

Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care.

Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mild to Moderate Depression.

Interventions

Type	Name	Description
DRUG	Antidepressants
OTHER	Active Monitoring

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-07-01
• Completion: 2015-07-01
• First posted: 2014-09-19
• Last updated: 2014-09-19