A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol.

Autor: Zandbergen MME; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands. m.zandbergen@erasmusmc.nl., Jansen EEL; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Jabbarian LJ; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.; MiSi NeuroPsy, Rotterdam, the Netherlands., de Koning HJ; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., de Kok IMCM; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Jazyk: angličtina
Zdroj: BMC psychology [BMC Psychol] 2024 Dec 18; Vol. 12 (1), pp. 742. Date of Electronic Publication: 2024 Dec 18.
DOI: 10.1186/s40359-024-02230-6
Abstrakt: Background: Mobile-based screening interventions to detect and treat Major Depressive Disorder (MDD) at an early stage might be a promising approach for reducing its societal burden. In the present study, we will evaluate the feasibility and effectiveness of screening for MDD using a mobile-based screening protocol.
Methods: This study will be a three-arm, parallel randomized control trial (RCT) performed in a multi-ethnic population within the municipality of Rotterdam (the Netherlands). The trial includes two intervention groups that will be screened 4-weekly for MDD for 12 months using the Patient Health Questionnaire (PHQ-9) and a control group who does not receive mobile-based screening for MDD. Participants in the one-test intervention arm will be referred for further diagnosis and treatment, if necessary, after a single positive test score for moderate-severe major depression symptoms (PHQ-9 > 10). Participants in the multiple-test intervention arm will only be referred after three consecutive positive test scores. 1786 eligible participants will be included in the RCT, with 446 and 447 in the one-test and multiple-test referral arms, respectively, and 893 in the control arm. Primary outcome is participants' QoL after 12 months (EQ-5D-5L). Secondary outcomes include participants' QoL after 24 months (EQ-5D-5L), evaluating the occurrence and severity of MDD symptoms (PHQ-9), intervention engagement, and identifying public mental health differences based on sociodemographic characteristics, including age, gender, ethnicity, financial situation, educational background, and living area. Long-term results of the RCT will be incorporated into a microsimulation model to determine the long-term benefits, harms, and costs of MDD screening.
Discussion: The information gained from examining the feasibility and (cost-) effectiveness of mobile-based screening for MDD could be of guidance for mental health policy implementations and support the introduction of mobile-based screening for MDD in the Netherlands and/or other nations.
Trial Registration: ClinicalTrials.gov: NL84280.078.23, NCT05989412 , August 8, 2024.
Competing Interests: Declarations. Ethics approval and consent to participate: The MOOD study was approved by the Central Committee on Research Involving Human Subjects (CCMO) of the Netherlands (reference: # NL84280.078.23) and started on September 1st, 2024. The study also received approval to obtain data remotely using a CTMS software application provided by Your Research. Approval was obtained by CCMO again (reference number: #NL84280.078.23). The study will be conducted according to the principles of the Declaration of Helsinki (6th edition, 2008) and in accordance with the Medical Research Involving Human Subjects Act (WMO). Participation is free and voluntary (participants must complete an informed consent form before entering the trial). We believe the risks associated with participation are negligible. At the study’s completion, all participants will be compensated as a symbol of appreciation. Researchers can be contacted during the intervention period when necessary. Any significant modifications to the protocol which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such an amendment will be agreed on and approved by the Medical Ethical Testing Committee of the Erasmus Medical Center before implementation. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz: