A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders (MAPDep)

Servicio Canario de Salud

Status: Completed

Conditions: Depressive Disorder

Treatments: Behavioral: Intervention to Psychiatrists; Behavioral: Intervention to Patients; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03668457

PI18-00767

Details and patient eligibility

About

Objective: The study of medication adherence in depression (MAPDep study) aims to evaluate the effectiveness and cost-effectiveness of a multi-component strategy to enhance patient-centered care to improve adherence toward medications in patients with depression, formed by an educational intervention to psychiatrists and/or a collaborative care intervention group to patients and relatives plus a reminder system through the use of a mobile APP. Methods: The objective will be assessed under an open multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care (control arm). In group 1 only patients and family members receive intervention, in group 2 only psychiatrists receive intervention, and group 3 is a combined intervention for patients and psychiatrists. The main measure will be the change in medication adherence rate. Secondary endpoints are depression, emotional distress, health-related quality of life, physical functioning, patients' knowledge about their medications, provider beliefs regarding patient-centeredness, and healthcare resource utilization.

Enrollment: 170 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients:

• Patients with diagnosis of depressive disorder (major depressive disorder MDD and/or dysthymia) under pharmacological treatment
• Regular users of mobile phones
• Patients who have consulted their psychiatrist about their depression at least once in the previous 6 months

Health professionals:

Psychiatrists have no intention of moving from their practice during the study period.

Exclusion criteria

• Patient:

• Patients with history of current bipolar disorder and/or any psychotic disorder
• Insufficient language skills
• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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170 participants in 4 patient groups

Intervention to Patients

Experimental group

Description:

Only patients receive intervention

Treatment:

Other: Control

Behavioral: Intervention to Patients

Intervention to Psychiatrists

Experimental group

Description:

Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals

Treatment:

Other: Control

Behavioral: Intervention to Psychiatrists

Mixed Intervention

Experimental group

Description:

Patients and Psychiatrists associated with these patients receive intervention

Treatment:

Other: Control

Behavioral: Intervention to Patients

Behavioral: Intervention to Psychiatrists

Control

Other group

Description:

Psychiatrists provide the usual care Patients receive usual care

Treatment:

Other: Control