Viewing Study NCT06419868



Ignite Creation Date: 2024-05-19 @ 5:34 PM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06419868
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-17
First Post: 2024-04-30

Brief Title: Acceptability and Feasibility of a Universal Preventive Intervention
Sponsor: Universidad de los Andes Chile
Organization: Universidad de los Andes Chile

Study Overview

Official Title: Acceptability and Feasibility of a Universal Preventive Intervention for Depression and Anxiety in University Students
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FDI2024
Brief Summary: 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 60 and 665 have depression between 77 and 655 anxiety disorders and between 122 and 967 present stress In China on the other hand a study reported in 2016 that the prevalence of depression was 238 In Latin America a Brazilian article conducted on medical students shows a prevalence of depression at 306 anxiety disorders at 329 and stress at 499

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 53 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 535 stress symptoms Furthermore 297 presented the three symptoms simultaneously and 51 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 229 and 407 of depressive symptoms between 165 and 388 of anxious symptoms between 165 and 237 of cannabis consumption in the last 12 months between 197 and 297 and alcohol consumption in the previous year between 840 and 926

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 371 to 2784 and that of anxious symptoms decreased slightly from 379 to 3613 A notable decrease was observed in stress going from 546 to 129 On the other hand the prevalence of suicide risk experienced a less pronounced decrease from 20 to 184 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
Detailed Description: 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 ClinicalTrialsgov 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 -125 anxiety d -109 and depression d -106 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 069 anxiety d 076 depression d 063 and improvements in academic productivity d 033 and academic work performance d 034 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

Unfortunately in Chile and Latin America no studies have evaluated preventive interventions using technology in the university population All the results presented come from developed countries but they are guidelines when designing an intervention that could be effective in our context It is also important to mention that whatever the intervention it must on the one hand incorporate the components that have been demonstrated as mediators in the prevention of depression and anxiety On the other hand they should be culturally relevant to promote involvement and adherence to this type of intervention in the university population Whether through an internet platform or mobile applications technology-based interventions are very promising in facilitating students access to this content In particular the Universidad de los Andes has a CANVAS platform that favors students work in their regular academic activities Based on the experience shown in other interventions such as the moodgym intervention it can be expected that if these platforms are culturally attractive to students they can generate better adherence Finally technology allows us to get closer to the common language in which university students are immersed At the same time if these interventions are effective they have a high potential for scaling up to promote better well-being at the population level These underscore the effectiveness of technology-based interventions not only in improving mental health symptoms but also in the accessibility and appeal of these programs to students who might not otherwise seek help

Based on the above review a successful universal mental health prevention program for university students should incorporate strategies that promote emotion regulation a crucial component for well-being and social adaptation Integrating mindfulness techniques and cognitive-behavioral therapy would make it easier for individuals to recognize and adequately manage their emotions Likewise the literature suggests the importance of developing skills for coping with academic stress through effectively assessing stressful situations and implementing strategies focused on problem-solving and emotional regulation skills In addition and according to the review aspects of psychoeducation on stress anxiety and depression problem-solving and development of healthy behaviors such as physical activity and sleep care should also be incorporated

In this study the principal investigator propose to develop and evaluate a brief online intervention that incorporates the mediators of effectiveness demonstrated in other interventions such as training in mindfulness skills emotional regulation coping with academic stress problem-solving and interpersonal effectiveness which will prevent symptoms of depression and anxiety on undergraduate students

2 Objectives 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

21 Primary objectives

1 Develop an online intervention aimed at preventing depression and anxiety strengthening emotional regulation skills mindfulness techniques healthy coping with stress problem-solving psychoeducational skills and healthy behaviors
2 Determine the participants acceptability and satisfaction with the intervention using the Client Satisfaction Questionnaire CSQ-8
3 Determine the feasibility of recruiting study subjects retaining participants attending sessions and collecting quantitative data during the program

22 Secondary objectives

1 Evaluate the effects of the intervention on the participants their depressive and anxious symptoms and their quality of life

3 Design This experimental study has a randomized controlled trial design and a control group

4 Participants The participants will be undergraduate students from the Universidad de los Andes with different majors

5 Intervention There are no proven interventions in university students that have evidence in Chile but the literature review highlights interventions that have worked in countries such as England Germany and Australia which incorporate the following contents and mediators emotion regulation mindfulness techniques coping skills problem-solving psychoeducation of anxiety and depression and development of healthy behaviors In this project the principal investigator will propose the design and creation of a self-applied online intervention that incorporates these components and that should initially have six modules which should be implemented in 4 to 8 weeks Participants will receive access to the CANVAS platform where they will find the sessions content in video audio and text format In addition they will be asked to practice some techniques at home with audiovisual material to guide them Participants will be asked to complete the six sessions sequentially completing each one before advancing to the next Session attendance data will be collected and evaluated

6 Outcomes 61 Primary response measures 611 Acceptability Assessment Acceptability will be evaluated by determining how this intervention program is received by students and the extent to which this intervention relates to the needs of this target population At the end of the program the research team will develop an acceptability and satisfaction questionnaire for the intervention students In addition the Client Satisfaction Questionnaire CSQ-8 instrument will be applied to evaluate satisfaction after implementation

612 Feasibility Assessment

To evaluate the feasibility the principal investigator will consider the following variables

1 Recruitment of participants and sample characteristics
2 Evaluation of data collection and results
3 Evaluation of the acceptability of the intervention and study procedures and response rates
4 Evaluation of resources and the ability to manage and implement the study and intervention
5 Preliminary evaluation of participants responses to the intervention
6 Level of progress of the participants in the sessions

62 Secondary response measures Validated measures for depression anxiety quality of life distress tolerance insomnia emotion regulation mindfulness skills cognitive behavior theory skills and suicide ideation will used at baseline after the intervention and four months after the completion of the intervention

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None