Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT07001202
Brief Summary:
Mental health in university students is a growing concern worldwide. In Chile, previous studies have shown high rates of depressive symptoms, anxiety, and suicidal risk in this population. This study seeks to evaluate the acceptability and feasibility of a Cognitive Behavioral Therapy (CBT)-based intervention for the indicated prevention of suicidality in undergraduate students, and also to explore its impact on reducing suicidal ideation. A quasi-experimental before-and-after design will be used with a sample of students from the Universidad de los Andes who present mild to moderate suicidal risk. As this is a pilot study, a sample size calculation is not required, but we expect to recruit 20 subjects, which will allow us to conduct acceptability and feasibility assessments and collect data for a larger-scale study. A follow-up will consist of repeating the initial assessment questionnaire, which will be completed two and four months after the intervention. The methodology includes an initial interview to assess inclusion and exclusion criteria, signing informed consent, and developing a safety plan with the students. Following this, six weekly sessions (three in-person and three with digital components) of 60 minutes each will be held, focusing on emotional regulation, cognitive restructuring, and problem-solving. The intervention will be facilitated by trained psychologists, under the supervision of a trained psychologist or psychiatrist. To assess acceptability, the Client Satisfaction Questionnaire (CSQ-8) will be primarily used.
To assess outcomes, validated instruments will be applied, such as the Columbia Suicide Risk Scale (C-SSRS), the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, the Generalized Anxiety Disorder 7 (GAD-7) for anxiety symptoms, the Short Form-12 Health Survey (SF-12) for quality of life, the Distress Tolerance Scale (DTS) for stress tolerance, the Community Assessment of Psychic Experiences-Positive (CAPE-P15) for psychotic symptoms, the Difficulties in Emotion Regulation Scale (DERS-E) for emotional regulation, the Social Problem-Solving Inventory-Revised (SPSI-R) for problem-solving, and the Cognitive-behavioural Therapy Skills Questionnaire (CBTSQ) for cognitive-behavioral skills. Reduction in suicidal ideation, satisfaction with the intervention, and program adherence will be measured.
The study hopes that the prevention program, along with the proposed assessments and procedures, will be appropriate and feasible in a university setting. This will allow progress toward a larger randomized controlled trial. Furthermore, it is expected that students in the intervention group will experience a reduction in suicidal ideation.
Detailed Description:
Mental health among university students has become, in recent years, a common and serious issue within higher education institutions worldwide, and Chile is no exception.
A systematic review and meta-analysis published in 2022 found a global prevalence of depressive symptoms among university students of 33.6% and anxiety symptoms of 39%. In Latin America, a study conducted in Brazil (2017) among medical students showed a prevalence of depression of 30.6%, anxiety disorders of 32.9%, and stress of 49.9%.
In Chile, there are few studies addressing the prevalence of mental health disorders among university students. In the "First National University Mental Health Survey," conducted in 2018 among 600 students from the Catholic University of Temuco, the University of Concepción, and the University of Tarapacá, 46% of students showed depressive symptoms, 46% anxiety symptoms, and 53.5% stress symptoms. Additionally, 29.7% presented all three symptoms simultaneously, and 5.1% of students had suicidal thoughts.
Data from the first Mental Health Survey at Universidad de los Andes, conducted in 2020 with 5,037 undergraduate students, showed a prevalence of depressive symptoms of 37.1% and anxiety symptoms of 37.9%. The prevalence of suicide risk was 20.0%. In the second survey at this institution in 2022, with 1,682 students participating, the prevalence of depression was 27.84%, anxiety 36.12%, and stress 2.91%. Suicidal ideation risk was found to be 18.7%.
The prevalence of suicidal ideation is alarming. However, it aligns with information from the World Health Organization (WHO), which states that suicide is the second leading cause of death among youth aged 15 to 29 worldwide.
Recent literature regarding suicide among university students is concerning. In the updated study of the Ten Great Schools, published by the National Academies of Sciences, Engineering, and Medicine, researchers found a suicide mortality rate of 5.6 per 100,000 students between 2009 and 2018.
A meta-analysis including 634,662 university students found high proportions of students experiencing suicidal thoughts, plans, and behaviors. The pooled lifetime prevalence estimates of suicidal ideation, plans, and attempts were 22.3%, 6.1%, and 3.2%, respectively. For the past 12-month prevalence, these figures were 10.6%, 3.0%, and 1.2%, respectively.
A cross-sectional study conducted in 2023 with 12,245 university students in Brazil found a prevalence of suicidal ideation of 5.9%. Variables most associated with suicidal ideation included a history of psychopathology, sexual abuse, dissatisfaction with course choice, and low academic performance.
The above was presented as background for suicide risk, but suicidal behavior has also been shown to have significant consequences in university students' lives. Suicide attempts are the most significant risk factor for completed suicide. Suicidal ideation is also strongly associated with a greater risk of future suicide. Moreover, experiencing mental health problems is associated with poor academic performance and increased dropout rates, with a 210% increase in the number of students who dropped out of their studies due to mental health problems in the past four years.
A meta-analytic synthesis published in 2021 evaluated risk factors related to suicide among university students. Adverse childhood experiences, underlying mental health problems, and financial difficulties predicted a higher risk of suicidal ideation and behavior. Regarding sexual minorities, the American College Health Association (ACHA) reported that 5.4% of transgender and gender non-conforming university students had attempted suicide in the past year, compared to 2.9% of cisgender men and 1.9% of cisgender women.
Considering all of the above, mental health disorders among university students remain a public health issue that should be addressed preventively through the implementation of evidence-based programs.
Following a public health model, suicide prevention strategies can be implemented at three levels: universal, selective, and indicated. Universal interventions target the general population. Selective interventions focus on subpopulations at higher risk, which can be identified based on sociodemographic characteristics, geographic distribution, or prevalence of mental disorders and substance use. Finally, indicated interventions are aimed at individuals known to be vulnerable to suicide or who have previously attempted suicide. In the university population, indicated prevention targets students showing warning signs or identified with potential suicide risk. A comprehensive suicide prevention program typically employs a combination of universal, selective, and indicated interventions.
In the United Kingdom, there is a national suicide prevention strategy for university students called the Suicide Safer University Strategy. It is based on pre-training members of the university community to enable them to carry out prevention and intervention with students. As training programs, they recommend interactive one- or two-day workshops such as the Applied Suicide Intervention Skills Training (ASIST). In the United States, there is a student suicide prevention guide developed by the Suicide Prevention Center of New York State. The indicated prevention model focuses on assessment and triage using semi-structured interviews, risk level determination using instruments such as the Columbia scale, collaborative safety planning such as the Stanley-Brown Safety Plan, notifying the primary support network, and timely referral to community health providers.
In 2019, Chile published its first set of recommendations for suicide prevention in educational institutions, which consists of six pillars: creating and maintaining a protective climate, preventing mental health problems and disorders, educating and raising awareness about suicide, detecting students at risk, acting protocols in case of an attempt or suicide, and postvention actions, as well as coordination and access to the health network.
On the other hand, a successful mental health prevention program for university students should include strategies that promote emotion regulation, a crucial component of well-being and social adaptation. One of the psychological theories that has most contributed to the development of preventive and therapeutic interventions in emotion management is cognitive-behavioral theory. Likewise, the literature highlights the importance of developing skills to cope with academic stress, such as effective appraisal of stressful situations and the use of problem-solving strategies.
A systematic review of suicide prevention in schools and universities included 35 studies, with a total of 24,270 participants. Of those 35 studies, 15 correspond to indicated prevention, and only 6 interventions are for indicated prevention in university populations, with the rest conducted in school populations.
Among the included studies, Fitzpatrick et al. (2005) conducted a randomized controlled trial using a brief audiovisual intervention focused on problem-solving and coping strategies. They found a decrease in suicidal ideation and depression in the intervention group, although the difference was not significant compared to the control group (26% vs. 22% improvement; p \> .10).
In a randomized controlled trial by Lin et al. (2019), a group of Taiwanese university students diagnosed with borderline personality disorder participated in a group cognitive-behavioral therapy (CBT) intervention aimed at reducing depression and suicide attempts. Another group participated in a skills training intervention based on dialectical behavior therapy (DBT). For the CBT group, a significant reduction in suicidal ideation was observed at 4, 8, 20, and 32 weeks of follow-up, with a large effect size (d = 5.24). For the DBT skills training group, a significant reduction in suicide attempts was found at 4, 8, 20, and 32 weeks of follow-up, with a small effect size (d = 0.32).
Instruments used to measure suicidal ideation and behavior included validated scales such as the Columbia Suicide Severity Rating Scale, the Beck Scale for Suicidal Ideation, and the Suicidal Behaviors Questionnaire-Revised (SBQ-R).
Study:
NCT07001202
Study Brief:
Protocol Section:
NCT07001202