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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Cost-effectiveness of a Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders

Conditions
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Depressive Disorder

Intervention / Treatment
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* Behavioral: Intervention to Patients
* Behavioral: Intervention to Psychiatrists
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention to Patients<br>Only patients receive intervention | Behavioral: Intervention to Patients<br>* Multifaceted intervention consisting of: A collaborative care management intervention, including depression education, medication management and behavioral activation. Use of a medication reminder mobile app.<br>Other: Control<br>* Other: Usual care Usual care for depressive disorder received in mental health units<br>|
| Experimental: Intervention to Psychiatrists<br>Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals | Behavioral: Intervention to Psychiatrists<br>* 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.<br>Other: Control<br>* Other: Usual care Usual care for depressive disorder received in mental health units<br>|
| Experimental: Mixed Intervention<br>Patients and Psychiatrists associated with these patients receive intervention | Behavioral: Intervention to Patients<br>* Multifaceted intervention consisting of: A collaborative care management intervention, including depression education, medication management and behavioral activation. Use of a medication reminder mobile app.<br>Behavioral: Intervention to Psychiatrists<br>* 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.<br>Other: Control<br>* Other: Usual care Usual care for depressive disorder received in mental health units<br>|
| Other: Control<br>Psychiatrists provide the usual care Patients receive usual care | Other: Control<br>* Other: Usual care Usual care for depressive disorder received in mental health units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Sidorkiewicz instrument score | Change in adherence from baseline to 6 months. This instrument contains 5 questions to help patients recognize their different medication-taking behaviors for each drug taken. The results generate adherence levels ranging from 1 (high drug adherence) to 6 (drug discontinuation). | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Sidorkiewicz instrument score | Change in adherence from baseline to 3 and 12 months. | Baseline, 3 and 12 months | 
| Change in Beck Depression Inventory - II (BDI-II) score | BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. | Baseline, 3, 6, and 12 months | 
| Change in Hospital Anxiety and Depression Scale (HADS) score | HADS contains two 7-item Likert scales, one for anxiety and one for depression, with responses being scored on a scale of 0-3 (3 indicates higher symptom frequencies). | Baseline, 3, 6, and 12 months | 
| Change in Physical Functioning Subscale (PF-10) of the 36-item Short Form Health Survey (SF-36) | PF-10 contains 10-item Likert scale designed to examine a person's perceived limitation with physical functioning. Each item is rated on a 3-point scale (yes, limited a lot; yes, limited a little; and no, not limited at all). | Baseline, 6, and 12 months | 
| Change in EQ-5D-5L | EQ-5D-5L is a questionnaire consisting of five domains (Mobility, Self-Care, Usual Activity, Pain/Discomfort and Anxiety/Depression) each with five levels (no problems, slight problems, moderate problems, severe problems and extreme problems). | Baseline, 6, and 12 months | 
| Change in Patient-Practitioner Orientation Scale (PPOS) score | PPOS is a self-administered questionnaire that assesses patient-centeredness healthcare professionals. PPOS contains 18 items scored on a 6-point Likert scale (strongly disagree to strongly agree). | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Medication adherence, Multicomponent intervention