Acceptability and Feasibility of a Universal Preventive Intervention for Depression and Anxiety in University Students

Universidad de los Andes, Chile0 个研究点目标入组 272 人开始时间: 2024年7月1日最近更新: 2024年5月17日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Universidad de los Andes, Chile
入组人数: 272
主要终点: Acceptability Assessment

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Mental health in the university population has become a common and serious problem within university institutions worldwide in recent years. Various meta-analyses and systematic reviews have shown worrying figures in the last five years. In the USA, it has been described in medical students that between 6.0% and 66.5% have depression, between 7.7% and 65.5% anxiety disorders, and between 12.2% and 96.7% present stress. In China, on the other hand, a study reported in 2016 that the prevalence of depression was 23.8%. In Latin America, a Brazilian article conducted on medical students shows a prevalence of depression at 30.6%, anxiety disorders at 32.9%, and stress at 49.9%.

In Chile, there are very few studies that address the prevalence of mental health disorders and associated risk factors in the university population. The article published in 2014 by Baader et al. is one of the first records was carried out on a population of 800 students in 2008 at the Austral University of Chile, reporting a prevalence of 27% of depression and 5.3% of students who present a moderate to severe risk of suicide. During April and May 2019, the results of the "First National University Mental Health Survey" project were presented, a project led by the Catholic University of Temuco and sponsored by the National Research and Development Agency (ANID), carried out to 600 students from the Catholic University of Temuco, the University of Concepción and the University of Tarapacá. This project showed that 46% of the students presented depressive symptoms, 46% anxiety symptoms, and 53.5% stress symptoms. Furthermore, 29.7% presented the three symptoms simultaneously, and 5.1% of the students had suicidal thoughts at the time of the study.

In a review of published studies on mental health in higher education students in Chile, a wide variability in the prevalence of psychological symptoms among students was identified. The findings showed a range of prevalence of psychological distress between 22.9% and 40.7%, of depressive symptoms between 16.5% and 38.8%, of anxious symptoms between 16.5% and 23.7%, of cannabis consumption in the last 12 months between 19.7% and 29.7%, and alcohol consumption in the previous year between 84.0% and 92.6%.

The data obtained from the Mental Health Surveys of the University of the Andes, applied in the years 2020 and 2022 to undergraduate students, indicate variations in the prevalence of different symptoms and psychological risks. Specifically, the prevalence of depressive symptoms decreased from 37.1% to 27.84%, and that of anxious symptoms decreased slightly from 37.9% to 36.13%. A notable decrease was observed in stress, going from 54.6% to 12.9%. On the other hand, the prevalence of suicide risk experienced a less pronounced decrease, from 20% to 18.4%, remaining at a considerably high rate.

Taking into account the above, mental health problems in the university population continue to be a public health problem that must be addressed preventively through the implementation of evidence-based programs.

Objective: This study aims to determine the acceptability and feasibility of an online universal mental health prevention program for university students. It is also expected to reduce depressive and anxious symptoms and improve quality of life.

Outcomes:

Primary response measures: Acceptability Assessment, Feasibility Assessment. Secondary response measures are depression, anxiety, and quality of life. The Outcomes section provides more details on anxiety and qu.

Expected results: The data collected will allow us to determine the acceptability and satisfaction of the participants with the intervention using a quantitative measure of its credibility and to explore its effects on the participants, considering the change in depressive and anxiety symptoms and quality of life before and after the intervention.

详细描述

STRATEGIES AND INTERVENTIONS ORIENTED ON THE PROMOTION AND PREVENTION OF MENTAL HEALTH PROBLEMS:

Recent research highlights the effectiveness of preventive interventions on the mental health of university students, whether through digital media, in-person actions, or a combination of both. The contents of these interventions have allowed us to establish the mechanisms and main mediators that explain the effectiveness of these interventions. For example, recent studies have demonstrated the positive effects of mindfulness on individual health, decreasing the intensity of distress, accelerating emotional recovery, and increasing the ability to engage in goal-oriented behavior. In mindfulness training, people learn to self-regulate their attention. In this sense, in 2021, a pilot study with a control group was carried out at the Universidad de los Andes (ClinicalTrials.gov Identifier: NCT05114824) in which an intervention based on Mindfulness with cognitive-behavioral elements of 8 sessions was evaluated in undergraduate students. It showed a significant reduction in depressive and anxiety symptoms and an increase in quality of life in those students who participated in the intervention compared to the control group. This intervention was based on a program developed by Dr. Elizabeth English and evaluated by Dr. Julieta Galante at the University of Cambridge with excellent results. Another study in England evaluated a mindfulness intervention, which achieved notable reductions in perceived stress (d = -1.25), anxiety (d = -1.09), and depression (d = -1.06) in comparison with a control group, with sustained benefits during 3 and 6 month follow-ups.

In Germany, a study evaluated an Internet-based intervention supported by a mobile application called "StudiCareStress." This intervention is based on cognitive-behavioral and third-wave techniques. It aligns with Lazarus' transactional model of stress by differentiating between problem-focused coping and coping focused on emotion regulation. Cognitive-behavioral problem-solving strategies are applied for problem-focused coping to reduce and eliminate modifiable stressors. Emotion regulation is how individuals monitor, evaluate, modify, and manage emotions to achieve relevant needs or goals. It has been shown to influence the reduction of various symptoms of emotional distress. The intervention comprised eight main modules. Completing 1 module took 30 to 90 minutes, and participants were recommended to complete at least one and a maximum of 2 modules per week. Therefore, the intervention was intended to be completed in approximately 5 to 7 weeks. This study revealed significant effects on stress relief (d = 0.69), anxiety (d = 0.76), depression (d = 0.63), and improvements in academic productivity (d = 0.33). ) and academic work performance (d = 0.34) after seven weeks.

Another study in Australia evaluated the "moodgym" program, a program that is delivered over the Internet and is entirely self-administered. This program incorporates cognitive behavioral strategies such as "attentional bias modification" and "information processing." About the modification of attention bias, they are strategies that reduce the tendency of individuals with emotional disorders to pay too much attention to negative information. These strategies enable people to reduce attention to this negative information but, at the same time, actively use positive or neutral information. On the other hand, "information processing" strategies try to reduce the biases that can occur in individuals with emotional disorders such as depression, on the one hand, disconnect from negative content, improve the processes of information interpretation, and reduce memory biases. Participants completed the intervention for six weeks in the study that evaluated this program. Participants were asked to spend 40 minutes weekly on "moodgym", complete the sessions in one sitting, and only log into "moodgym" when prompted. Participants who completed the intervention had continued improvement in depressive symptoms. Furthermore, significantly fewer people in the intervention condition had diagnostic criteria for major depression at follow-up than in the control group.

In a recent review, it was concluded that Internet-based interventions for the mental health of university students can have significant effects on depression, anxiety, and other mental health problems. When reviewing the components of the programs included in this review, it was also possible to conclude that the majority of these interventions, in addition to incorporating training in specific skills, either from cognitive behavioral theory or different aspects of emotional regulation, most of them also incorporate psychoeducational aspects and others related to the development of healthy behaviors such as the use of physical exercise and sleep hygiene.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Undergraduate students from the Universidad de los Andes, from different majors.
•Over 18 years.
•Able to read and speak Spanish.
•Availability of time to participate.

排除标准

•PHQ-9 score ≥ 15
•Active suicidality, defined as suicidal ideation, planning or attempts, or self-harming behavior in the last 12 months. The Columbia Suicidality Scale will be used to exclude students with a score ≥
•Who is undergoing psychiatric treatment for a serious condition, understood as psychotic pathology and/or substance abuse.
•History of hospital admission for psychiatric pathology in the last two years.