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

Summary

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.

Conditions

• Depressive Disorder

Interventions

BEHAVIORAL

Intervention to Patients

Multifaceted intervention consisting of: 1. A collaborative care management intervention, including depression education, medication management and behavioral activation. 2. Use of a medication reminder mobile app.

BEHAVIORAL

Intervention to Psychiatrists

Educational intervention consisting of theoretical and practical sessions to to improve communication and negotiation abilities, and to develop skills to promote patient-centered care and shared decision-making.

OTHER

Control

Other: Usual care Usual care for depressive disorder received in mental health units

Sponsors & Collaborators

• University of La Laguna

  collaborator OTHER

• Servicio Canario de Salud

  lead OTHER

Principal Investigators

• María del Mar Trujillo Martín, PhD · Servicio de Evaluación del Servicio Canario de la Salud

• Carlos de las Cuevas Castresana, MD, PhD · University of La Laguna

• Tasmania del Pino-Sedeño, PhD · University of La Laguna

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2022-11-01

Completion

2022-11-01

Countries

• Spain

Study Locations