Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antidepressants | Naturalistic assignment: Patients whose physician decides to indicate antidepressants. |
| |
| Active Monitoring | Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidepressants | Drug |
| ||
| Active Monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measures: Severity of Depression (PHQ-9), Quality of life (EuroQol) and the use of services (Client Service Receipt Inventory, CSRI). | At base Line, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 1.Quality of life of patients with major depression who initiate treatment in Primary Care. | At base line, 6 months and 12 months. | |
| 2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary. | At base line, 6 months and 12 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Primary care patients who suffer from major depression.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antoni Serrano, PhD | Fundació Sant Joan de Déu | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25885818 | Derived | Rubio-Valera M, Beneitez I, Penarrubia-Maria MT, Luciano JV, Mendive JM, McCrone P, Knapp M, Sabes-Figuera R, Kocyan K, Garcia-Campayo J, Serrano-Blanco A. Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study). BMC Psychiatry. 2015 Mar 31;15:63. doi: 10.1186/s12888-015-0448-3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided