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Depressive DisorderMAPDepNCT03668457

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

A study testing Intervention to Patients and Intervention to Psychiatrists in people with Depressive Disorder, run by Servicio Canario de Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depressive Disorder
What is being tested?
Intervention to Patients and Intervention to Psychiatrists
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteSpain
Study dates
1 Mar 2020to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Servicio de Evaluación. Servicio Canario de Salud

    Santa Cruz de Tenerife, 38004

Other trials in Spain

About this study

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

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.

Being tested
Intervention to Patients, Intervention to Psychiatrists, Control
Keywords
Depression, Medication adherence, Multicomponent intervention
Medical subject headings
Depressive Disorder, Depression, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention to PatientsBehavioural

    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.

  • Intervention to PsychiatristsBehavioural

    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.

  • ControlOther

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

Study groups in NCT03668457
Study groupRoleWhat they receive
Intervention to PatientsExperimentalOnly patients receive intervention
Receives: Behavioral: Intervention to Patients; Other: Control
Intervention to PsychiatristsExperimentalPsychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals
Receives: Behavioral: Intervention to Psychiatrists; Other: Control
Mixed InterventionExperimentalPatients and Psychiatrists associated with these patients receive intervention
Receives: Behavioral: Intervention to Patients; Behavioral: Intervention to Psychiatrists; Other: Control
ControlOtherPsychiatrists provide the usual care Patients receive usual care
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and 6 months

Secondary outcomes (6)

  1. Change in the Sidorkiewicz instrument score

    Change in adherence from baseline to 3 and 12 months.

    Measured: Baseline, 3 and 12 months

  2. 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.

    Measured: Baseline, 3, 6, and 12 months

  3. 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).

    Measured: Baseline, 3, 6, and 12 months

  4. 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).

    Measured: Baseline, 6, and 12 months

  5. 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).

    Measured: Baseline, 6, and 12 months

  6. 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).

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start1 Mar 2020
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03668457
Sponsor's protocol ID
PI18-00767
Acronym
MAPDep
Status last verified
Apr 2023
First submitted
9 Jul 2018
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Del Pino-Sedeno T, Penate W, de Las Cuevas C, Valcarcel-Nazco C, Fumero A, Serrano-Perez PG, Acosta Artiles FJ, Ramos Garcia V, Leon Salas B, Bejarano-Quisoboni D, Trujillo-Martin MM. 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. Patient Prefer Adherence. 2019 Feb 22;13:309-319. doi: 10.2147/PPA.S172963. eCollection 2019.

    PubMed 30863020

Questions about this trial

What is this clinical trial studying?

A study testing Intervention to Patients and Intervention to Psychiatrists in people with Depressive Disorder, run by Servicio Canario de Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Sidorkiewicz instrument score (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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