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.

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.

Study Overview

• Status: Unknown
• Conditions: Mild to Moderate Depression.
• Intervention / Treatment: Drug: Antidepressants; Other: Active Monitoring

• Study Type: Observational
• Enrollment (Actual): 263

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care patients who suffer from major depression.

Description

Inclusion Criteria:

1. 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.
2. Adults (≥18 years)
3. Informed consent signed by the physician and the patient to participate in the study.

Exclusion Criteria:

1. Use of antidepressant drugs during the previous 60 days to inclusion date.
2. Alcohol or other toxic abuse.
3. Psychosis or bipolar disorder identified in the psychiatric interview
4. Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic
5. Health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs.
6. Terminal illness.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Investigators: Principal Investigator: Antoni Serrano, PhD, Fundació Sant Joan de Déu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (ESTIMATE): September 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Primary Care; Cost-effectiveness; Pharmacological treatment; Watchful-waiting or Active Monitoring.
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: Infap