Integrated Depression Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Ghent

About this trial

The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

persons between 18-65

presenting to the general practitioner's office

with depressive symtomatology

Disqualifiers

Severe depression warranting direct referral to specialized services

Trial design

Design model

Single group

Treatments tested in this trial

  • Integrated care

    Other intervention

    The intervention will be modelled based on the most frequently reported patient, family physician and specialist barriers in depression management. In this project, multiple interventions aiming to tackle these barriers will be set up, with the WHO Framework on Integrated People-Centred Health Services (IPCHS) serving as conceptual backbone to the study (Table 1). The IPCHS distinguishes five interdependent strategies supporting a shift in healthcare delivery, management and funding towards universal health coverage. These strategies are: 1. empowering and engaging people and communities; 2. strengthening governance and accountability; 3. reorienting the model of care; 4. coordinating services within and across sectors; 5. creating an enabling environment.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Integrated care armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intervention integration

Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.

Time frame
14 months

Secondary outcomes

1

Depression

PHQ-9 (Patient Health Questionnaire. DSM-5 depression), A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression

Time frame
12 months
2

Depression and anxiety

OQ-45-2 (Outcome Questionnaire. Transdiagnostical instrument focused on anxiety and depression) Total Score * Total scores (≥ 64) reflect increased distress * High is anything above 105 * Moderately High is between 83 and 105 * Moderate is between 64 and 82 * Low is anything below 64 Symptom Distress (SD) * Scores (≥ 37) indicate subjective discomfort Interpersonal Relations (IR) * Scores (≥ 16) reflect problems in interpersonal relations. Social Role (SR) * Scores (≥ 13) indicate dissatisfaction, conflict, distress, and inadequacy in performance of tasks related to employment, school, family roles and leisure life.

Time frame
12 months
3

Medication adherence and self-efficacy

MARS-5 (Medication adherence report score) Each item was rated on a 5-point Likert scale, and the range of the MARS-5 total score is between 5 and 25. A higher score on the MARS-5 represents better medication adherence. \<21 suboptimal adherence. MUSE (Medication Understanding and Use Self-Efficacy Scale). Score 8-32. Higher scores are better.

Time frame
12 months
4

Resource use

iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use

Time frame
12 months

Other outcomes

Sponsors and contacts

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University Ghent

Lead sponsor

Universiteit Antwerpen

Collaborator

Janssen-Cilag Ltd.

Collaborator