Acceptability and Feasibility of a Universal Preventive Intervention

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.

1. 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.

1. Design: This experimental study has a randomized controlled trial design and a control group.
2. Participants: The participants will be undergraduate students from the Universidad de los Andes with different majors.
3. 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.
4. 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.