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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Acceptability of the CARIBOU Integrated Care Pathway
研究概览
简要总结
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)
- 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.
- 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.
- 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.
详细描述
A) THEORETICAL-CONCEPTUAL FOUNDATIONS AND STATE OF THE ART Definition and magnitude of the problem Major Depressive Disorder (MDD) is a distinct diagnosis outlined in the DSM-5, characterized by episodes lasting at least two weeks, often much longer, with changes in mood, thinking, and neurovegetative functions (sleep, appetite, and energy) and periods of remission between episodes. MDD symptoms are consistent and valid, classified into mild, moderate, and severe forms based on nine specific symptoms. Severity is determined by symptom count, intensity, and impairment level, with this classification method widely used in population studies and primary care settings. Mild depression involves fewer symptoms and minimal impairment, while severe depression includes all DSM-5 symptoms or severe impairment. Moderate depression falls in between. Most episodes last 3-6 months in community samples and 5-8 months in referred samples. However, 20% of adolescents may experience episodes lasting two years or more, with more than half having a recurrence within five years. Predictors of recurrence include poor treatment response, symptom severity and chronicity, previous episodes, comorbidity, negative cognitive style, family problems, low socioeconomic status, and exposure to family conflict or violence.
Major Depressive Disorder in adolescents (MDD-A) is common, with the National Comorbidity Survey-Adolescent Supplement (NCS-A) showing lifetime and 12-month prevalence rates of 11.0% and 7.5%, respectively, among adolescents aged 13 to 18. Prevalence increases significantly during adolescence, especially among females. Most cases involve psychiatric comorbidity and severe role impairment, with many reporting suicidality. Adolescents are considered to have severe MDD if they have at least five criteria plus a specific suicide plan, psychotic symptoms, a family history of bipolar disorder, or severe functional impairment.
Several studies have alerted about a significant deterioration in mental health among adolescents in the post-COVID-19 period. For instance, a recent study including 5,368 Canadian secondary school students who participated in three consecutive waves during the 2018-19, 2019-20, and 2020-21 school years, found that the proportion of adolescents with significant depressive (29.4%) and moderate-to-severe anxiety (17.6%) symptoms at baseline increased by 1.5 times, reaching 44.8% and 29.8% in the ongoing pandemic period, respectively.
In Chile, it is estimated that the prevalence at the national level of MDD in the adolescent population is 8.3%. There is concern regarding these figures because only between 20% and 50% of depressed adolescents finally access treatment. In a more recent study, 2,022 students from the first to the third grades of secondary education (9th to 11th grade) from 8 schools (average age, 15.2 years; 49.5% were women) were surveyed. Using the Patient Health Questionnaire-9 (PHQ-9) to explore depressive symptoms, 35.2% of the students had a score to be classified at risk of having a MDD-A (PHQ-9>10). There is no data on the prevalence of MDD-A in the post-COVID-19 period.
An MDD-A is debilitating, impacting the development in several areas. A recent meta-analysis of longitudinal studies found that adolescent depression was associated with outcomes including, but not limited to, failure to complete secondary school, unemployment, and pregnancy/parenthood. Additionally, MDD-A is also a risk factor for suicide. Some studies have shown that in primary care (PC), as many as 2 in 3 youth with depression are not identified and fail to receive any care. Treatment in any form was received by most adolescents with 12-month DSM-IV MDD (60.4%), but only a minority received treatment that was disorder-specific or from the mental health sector. Another study showed that 62% of individuals with a psychiatric disorder had not accessed any mental health services in the past year. This study also showed that these individuals exhibited fewer antisocial traits and disorders, more anxiety disorders, and less comorbidity compared to those receiving treatment. This suggests that individuals with anxiety disorders may be less likely to seek services and highlights that access to Child and Adolescent Mental Health Services (CAMHS) often requires more complex cases with high levels of comorbidity and impairment. In addition, the same longitudinal study found that among 14-year-old adolescents with a DSM-IV psychiatric disorder, those who used mental health services experienced a substantial reduction in depressive symptoms by the 36-month follow-up. By contrast, by age 17, adolescents who did not access mental health services were seven times more likely to report clinical-level depression symptoms compared to those who did seek help.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
No masking is used because of the nature of the intervention and the cluster-randomized design.
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 15 to 18 years (up to their 19th birthday).
- •Presenting at one of the participating primary care centers.
- •The primary care physician considers depressive symptoms to be a priority treatment target.
- •PHQ-9 score ≥5 at screening.
- •Meet DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder, confirmed using the MINI-KID.
- •Able to read and write in Spanish.
- •Able to provide informed assent/consent, with parent or legal guardian consent when applicable.
排除标准
- •Severe depressive symptoms (PHQ-9 score ≥20).
- •Active psychotic symptoms (persistent delusions, hallucinations, or disorganized speech affecting functioning).
- •Bipolar disorder (type I or II).
- •Moderate or severe substance use disorder.
- •Autism spectrum disorder or intellectual disability.
- •Moderate or severe eating disorder.
- •Imminent suicide risk requiring immediate intervention (e.g., hospitalization).
- •Inability to read or write in Spanish.
- •Inability to provide informed consent/assent.
- •Under the care of state-based institutions without available family support.
- •Receiving ongoing individual psychotherapy or pharmacotherapy for depression or anxiety at another healthcare center
研究组 & 干预措施
CARIBOU Integrated Care Pathway
Participants receive the CARIBOU Integrated Care Pathway, including psychoeducation, cognitive behavioral therapy (group or individual) or Brief Psychological Intervention, caregiver support, measurement-based care, medication management when clinically indicated, and multidisciplinary team reviews over 24 weeks.
干预措施: CARIBOU Integrated Care Pathway (Behavioral)
Treatment As Usual (TAU)
Participants receive standard outpatient care provided in Chilean primary care centers. Treatment may include assessment, medication management, psychotherapy, referrals, and other services according to routine clinical practice, without the structured CARIBOU pathway or measurement-based care.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Acceptability of the CARIBOU Integrated Care Pathway
时间窗: week 24
Acceptability of the intervention will be assessed using a questionnaire developed by the research team and qualitative interviews with adolescents, caregivers, and healthcare professionals.
Participant Satisfaction
时间窗: Week 24
Satisfaction with the intervention will be assessed using the adapted Client Satisfaction Questionnaire (CSQ-8). This is an 8-item instrument, validated in English and subsequently translated and validated into Spanish, that measures overall satisfaction with health services received across various populations. Responses are Likert-type, with four options each. It also includes space for comments and suggestions. This instrument will be slightly adapted to questions oriented to the context of the study. The CSQ has an internal consistency range of α = 0.83 to α = 0.93
Recruitment Feasibility
时间窗: Up to 30 months
Number of participants recruited who complete the baseline assessment.
Baseline Assessment Completion
时间窗: Baseline
Percentage of participants completing the baseline assessment within 2 hours.
Clinician Adherence to the CARIBOU Model
时间窗: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Mean clinician adherence score assessed using clinician adherence forms, checklists, and chart reviews.
Retention of Outcome Assessments
时间窗: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Proportion of completed scheduled Mood and Feelings Questionnaire (MFQ) assessments across all planned time points.
次要结局
- Depressive Symptoms(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Overall Functioning(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Anxiety Symptoms(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Health-Related Quality of Life(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Family Functioning(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
研究者
Jorge Gaete
Full Professor
Universidad de los Andes, Chile