Effectiveness and cost-effectiveness of a multicomponent intervention to improve medication adherence in people with depressive disorders - MAPDep: a study protocol for a cluster randomized controlled trial

Tasmania Del Pino-Sedeño, Wenceslao Peñate, Carlos de Las Cuevas, Cristina Valcarcel-Nazco, Ascensión Fumero, Pedro Guillermo Serrano-Pérez, Francisco Javier Acosta Artiles, Vanesa Ramos García, Beatriz León Salas, Daniel Bejarano-Quisoboni, María M Trujillo-Martín, Tasmania Del Pino-Sedeño, Wenceslao Peñate, Carlos de Las Cuevas, Cristina Valcarcel-Nazco, Ascensión Fumero, Pedro Guillermo Serrano-Pérez, Francisco Javier Acosta Artiles, Vanesa Ramos García, Beatriz León Salas, Daniel Bejarano-Quisoboni, María M Trujillo-Martín

Abstract

Purpose: Depression is a widespread mental disorder which can be treated effectively. However, low adherence to antidepressants is very common. The study of medication adherence in depression (MAPDep study) assesses the effectiveness and cost-effectiveness of a multicomponent strategy to enhance adherence toward medications in patients with depression.

Intervention: The intervention is a multicomponent one consisting of an educational program for psychiatrists and/or a collaborative care program for patients and relatives, plus a reminder system that works through the use of an already available high-quality medication reminder application.

Study design: MAPDep study is an open, multicenter, four-arm cluster randomized controlled trial. The clusters are mental health units where psychiatrists are invited to participate. The clusters are randomly allocated to one of the three interventions or to usual care (control arm). Patients (18-65 years of age) diagnosed with depressive disorder, those taking antidepressant medication for an existing diagnosis of depression, and mobile phone users are selected. In group 1, only patients and relatives receive intervention; in group 2, only psychiatrists receive intervention; and in group 3, patients/relatives and psychiatrists receive intervention. The primary outcome is adherence to the antidepressant drug. The calculated sample size is 400 patients. To examine changes across time, generalized linear mixed model with repeated measures will be used. A cost-effectiveness analysis will be conducted. The effectiveness measure is quality-adjusted life years. Deterministic sensitivity analyses are planned.

Conclusion: MAPDep study aims to assess a multicomponent strategy to improve adherence toward medications in patients with depression, based not only on clinical effectiveness but also on cost-effectiveness. This methodology will enhance the transferability of the expected results beyond mental health services (patients and psychiatrists) to health care policy decision making.

Clinical trial identifier: NCT03668457.

Keywords: behavior modification; cost-effectiveness; depression; education; medication adherence; mobile phone technology.

Conflict of interest statement

Disclosure The authors have no conflict of interest in the subject matter or materials discussed in the manuscript.

Figures

Figure 1
Figure 1
Flowchart of MAPDep study procedures. Notes:*Patients: Demographic data, history of depression, depression health status, DAI-10, MHLC-C, HPRS, CPS, BMQ, adherence, BDI-II, HADS, SF-12, EQ-5D-5L; healthcare utilization and productivity losses (collected information will cover the six-month period prior to the study). Psychiatrists: Demographic data, years in practice, professional profile, PPOS and LATCon II. Abbreviations: BDI-II, Beck Depression Inventory-II; BMQ, Beliefs about Medicines Questionnaire; CMHU, Community Mental Health Unit; CPS, Control Preferences Scale; DAI-10, Drug Attitude Inventory – 10 Items; EQ-5D-5L, EuroQol-5D-5L; HADS, Hospital Anxiety and Depression Scale; HPRS, Hong Psychological Reactance Scale; LATCon II, Leeds Attitude Towards Concordance II Scale; MHLC-C, Multidimensional Health Locus of Control, Form C; PPOS, Patient-Practitioner Orientation Scale; SF-12, Short Form-12.

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