Acceptability and Feasibility of a Universal Preventive Intervention

NCT ID: NCT06419868

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-04-30

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 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.

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 (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.

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.

2.1. 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 participant's 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.

2.2. 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: 6.1. Primary response measures 6.1.1. 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.

6.1.2. 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.

6.2 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.

Conditions

Depression/Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

This is a self-applied online intervention with six modules. It should be implemented over a period of 4 to 8 weeks. Participants will be guided through the program in a structured manner. They will start by accessing the CANVAS online platform, where they will find the content of the sessions in video, audio, and text formats. They will then be directed to practice exercises at home, with audiovisual material to guide them. It's crucial that participants complete the six sessions sequentially, as each session is designed to build upon the previous one, ensuring a comprehensive learning experience and effective learning.

Group Type: EXPERIMENTAL

"Universal preventive intervention for depression and anxiety for university students"

Intervention Type: BEHAVIORAL

This is a self-applied online intervention with six modules. It should be implemented over a period of 4 to 8 weeks. It includes emotion regulation, mindfulness exercises, coping strategies, problem-solving strategies, psychoeducation of anxiety and depression, and the development of healthy behaviors, explained through the following theoretical components: mindfulness and cognitive behavioral therapy.

Participants will be guided through the program in a structured manner. They will start by accessing the CANVAS online platform, where they will find the content of the sessions in video, audio, and text formats. They will then be directed to practice exercises at home, with audiovisual material to guide them. It's crucial that participants complete the six sessions sequentially, as each session is designed to build upon the previous one, ensuring a comprehensive learning experience and effective learning.

Control group

Control group participants will be asked to respond to the baseline, after intervention, and four months after intervention. Once the study period is completed, and if the results show positive changes in the intervention group, they will be offered and asked to access the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"Universal preventive intervention for depression and anxiety for university students"

This is a self-applied online intervention with six modules. It should be implemented over a period of 4 to 8 weeks. It includes emotion regulation, mindfulness exercises, coping strategies, problem-solving strategies, psychoeducation of anxiety and depression, and the development of healthy behaviors, explained through the following theoretical components: mindfulness and cognitive behavioral therapy.

Participants will be guided through the program in a structured manner. They will start by accessing the CANVAS online platform, where they will find the content of the sessions in video, audio, and text formats. They will then be directed to practice exercises at home, with audiovisual material to guide them. It's crucial that participants complete the six sessions sequentially, as each session is designed to build upon the previous one, ensuring a comprehensive learning experience and effective learning.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cuidate

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 ≥ 3.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de los Andes, Chile

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gaete

Tenured Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jorge E Gaete, MD, PhD

Role: CONTACT

jgaete@uandes.cl

+56226181000 ext. 2277

Valentina Romo

Role: CONTACT

vromo@miuandes.cl

+56984038329

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Other Identifiers

FDI UAN23102

Identifier Type: -

Identifier Source: org_study_id