Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 263
- 主要终点
- Compare the cost-effectiveness of active monitoring (standard treatment without antidepressants) vs antidepressants in mild major depression taking into account the severity and disability in Primary Care. The changes at Time Frame will be assessed.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose GP considers to have major depression. The indication of pharmacological or non-pharmacological treatment will be based strictly on the clinical judgment of the physician.
- •Adults (≥18 years)
- •Informed consent signed by the physician and the patient to participate in the study.
排除标准
- •Use of antidepressant drugs during the previous 60 days to inclusion date.
- •Alcohol or other toxic abuse.
- •Psychosis or bipolar disorder identified in the psychiatric interview
- •Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic
- •Health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs.
- •Terminal illness.
研究组 & 干预措施
Antidepressants
Naturalistic assignment: Patients whose physician decides to indicate antidepressants.
干预措施: Antidepressants (Drug)
Active Monitoring
Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.
干预措施: Active Monitoring (Other)
结局指标
主要结局
Compare the cost-effectiveness of active monitoring (standard treatment without antidepressants) vs antidepressants in mild major depression taking into account the severity and disability in Primary Care. The changes at Time Frame will be assessed.
时间窗: At base Line, 6 months and 12 months.
Measures: Severity of Depression (PHQ-9), Quality of life (EuroQol) and the use of services (Client Service Receipt Inventory, CSRI).
次要结局
- 2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary.(At base line, 6 months and 12 months.)
- 1.Quality of life of patients with major depression who initiate treatment in Primary Care.(At base line, 6 months and 12 months.)