Clinical Research Directory

Evaluation of the Acceptability, Feasibility and Exploration of the Efficacy of an Integrated Care Pathway CARIBOU

Sponsor: Universidad de los Andes, Chile

Summary

Problem statement. Major Depressive Disorder (MDD) is a significant concern among adolescents, characterized by episodes of mood changes, cognitive symptoms, and neurovegetative dysfunction, often lasting months or even years, with a high recurrence rate. In Chile, the prevalence of adolescent MDD is estimated at 8.3%, but only a fraction receive treatment. Post-COVID-19 studies indicate a deterioration in adolescent mental health globally. Treatments for MDD include various psychotherapies, medications like Selective Serotonin Reuptake Inhibitors (SSRIs), and combined approaches, though many adolescents remain untreated or receive non-specific care. Integrated Care Pathways (ICPs), such as the CARIBOU, show promise in providing structured, multidisciplinary care. The CARIBOU model includes components like individual and group Cognitive Behavior Therapy (CBT), caregiver support, and medication algorithms within a Measurement-Based Care (MBC) framework. Pilot studies indicate the feasibility of such interventions, but further research is needed, particularly in resource- limited settings like Chile. Recent initiatives by the Chilean Ministry of Health, underscore the urgency and potential for implementing ICPs like CARIBOU in primary care to address adolescent depression effectively. General Objective: To evaluate the acceptability, feasibility, and explore the efficacy of CARIBOU pathway in treating adolescent depression in primary care. Specific Objectives (SO) 1. To assess the acceptability of the various components of the CARIBOU care model among adolescents, parents/caregivers, and healthcare professionals involved in the treatment of depression in primary care. 2. To assess the feasibility of implementing the different components of the CARIBOU care model for adolescents in the treatment of depression in primary care settings. For example, determine if the research team can recruit a sufficient number of participants at each participating health center within the time of the pilot cluster Randomized Controlled Trial (cRCT) study, evaluate the adherence of healthcare professionals in offering and implementing the proposed interventions, and estimate the participation level of students, parents/caregivers, and healthcare professionals in completing multiple longitudinal outcome assessments to provide sufficient data for a valid analysis. 3. To explore the efficacy of the ICP CARIBOU in reducing depressive symptoms, as measured by the short form of Mood and Feelings Questionnaire (MFQ), compared to treatment as usual (TAU) over 24 weeks. Similarly, determine if the use and implementation of CARIBOU are more effective in reducing anxiety symptoms, measured by the Generalized Anxiety Disorder 7 (GAD-7), and in improving quality of life, measured by the KIDSCREEN-27, family functioning measured by the The McMaster Family Assessment Device - General Functioning Subscale (MFAD-GF), and the overall functionality using the Columbia Impairment Scale, Youth Version (CIS-Y). Methodology. To achieve these objectives, the project will be divided into two phases. I) Formative work: a) the Translation and cultural adaptation of the program of the different components CARIBOU ICP, and b) Youth and family engagement in enhancing the design and relevance of CARIBOU interventions for adolescent depression. And II) The Intervention evaluation phase: a) a Pilot cluster Randomized Controlled Trial study to assess the acceptability and feasibility of implementation CARIBOU ICP in primary care centers and to explore the efficacy of the intervention in reducing depressive and anxiety symptoms and functional impairment and improving quality of life in primary care settings in Chile. This study will involve 72 depressed adolescents and their families randomly allocated to the CARIBOU ICP group (n=36, in two CESFAMs) and to the Treatment As Usual (TAU) (n=36, in two CESFAMs) Expected outcomes. The research project is anticipated to deliver several key outcomes across two phases. In the formative phase, the project will successfully translate and culturally adapt the CARIBOU intervention materials for Chile. This phase will ensure the intervention and assessment tools are culturally relevant and reliable. In the evaluation phase, a pilot cRCT will assess the acceptability and feasibility of implementation of CARIBOU and will explore the intervention's efficacy, aiming to show significant reductions in depression and anxiety symptoms and improvements in overall well-being and social functioning among adolescents. The successful dissemination of findings will inform clinical practices and policymakers, potentially leading to a larger evaluation and dissemination of the CARIBOU intervention in primary care settings, thereby benefiting adolescent mental health in Chile.

Official title: Evaluation of the Acceptability, Feasibility and Exploration of the Efficacy of an Integrated Care Pathway CARIBOU in Reducing Depressive Symptoms in Adolescents With Major Depressive Episode in Primary Care Centers

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