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

NCT02245373 | Unknown

• 1 other identifier: Infap
• Study Type: observational
• Target: 263
• Locations: 0 countries
• Sites: N/A

Brief 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.

Keywords

Depression; Primary Care; Cost-effectiveness; Pharmacological treatment; Watchful-waiting or Active Monitoring.

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Antidepressants

Naturalistic assignment: Patients whose physician decides to indicate antidepressants.

Drug: Antidepressants

Active Monitoring

Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.

Other: Active Monitoring

Interventions

Antidepressants DRUG

Antidepressants

Active Monitoring OTHER

Active Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care patients who suffer from major depression.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Related Publications (1)

• 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.

  PMID: 25885818 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Antoni Serrano, PhD

  Fundació Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 19, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 19, 2014

Record last verified: 2014-09