Depression Mild Clinical Trial
— IDECAOfficial title:
Integrated Depression Care Project
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).
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | ELZ Mechelen-Katelijne | Mechelen | |
Belgium | ELZ Voorkempen | Zoersel |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Janssen-Cilag Ltd., Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention integration | Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews. | 14 months | |
Secondary | 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 | 12 months | |
Secondary | 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. |
12 months | |
Secondary | 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. |
12 months | |
Secondary | Resource use | iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use | 12 months | |
Secondary | Health-related Quality of Life | EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health. | 12 months | |
Secondary | Health literacy | HLS-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) | 12 months |
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