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Integrated Depression Care

Integrated Depression Care Project

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05788198
Acronym
IDECA
Enrollment
150
Registered
2023-03-28
Start date
2023-04-25
Completion date
2024-09-30
Last updated
2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mild, Depression Moderate, Depression Severe

Brief summary

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).

Detailed description

The following deliverables apply: 1. Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels; 2. Training module for physicians and other care providers in population health management for patients with depression; 3. Training module for case managers/integration of a case management function into existing depression service offerings; 4. A patient education module for depression self-management; 5. A financing model for integrated depression care.

Interventions

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.

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
Janssen-Cilag Ltd.
CollaboratorINDUSTRY
University Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Investigators, care providers, and participants will know treatment arm allocation.

Intervention model description

Pre/Posttest implementation study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* persons between 18-65 * presenting to the general practitioner's office * with depressive symtomatology

Exclusion criteria

* Severe depression warranting direct referral to specialized services Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.

Design outcomes

Primary

MeasureTime frameDescription
Intervention integration14 monthsNomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.

Secondary

MeasureTime frameDescription
Depression and anxiety12 monthsOQ-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.
Medication adherence and self-efficacy12 monthsMARS-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.
Depression12 monthsPHQ-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
Health-related Quality of Life12 monthsEQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health.
Health literacy12 monthsHLS-EU-Q16. Considering the HLS-EUQ16 score, three levels of health literacy were defined: - inadequate HL (0-8) - problematic HL (9-12) - adequate HL (13-16)
Resource use12 monthsiMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use

Countries

Belgium

Contacts

Primary ContactRuben P Willems, PhD
ruben.willems@ugent.be+32488307749
Backup ContactLiesbeth Borgermans, PhD
liesbeth.borgermans@ugent.be+32473991090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026