Acceptability and Feasibility of a Preventive Indicated Intervention for Suicidality in University Students: Reframe-IT+U
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Client Satisfaction Questionnaire (CSQ-8)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age 18 or older.
- •Undergraduate students at Universidad de los Andes.
- •Able to read and speak Spanish.
- •Mild to moderate suicide risk in the past month, defined as having answered "Yes" to items 1, 2, 3, and/or 4 on the Columbia Suicide Severity Rating Scale (C-SSRS).
排除标准
- •Severe suicide risk, defined as having answered "Yes" to item 5 (past month) or item 6 (past 3 months) on the Columbia Suicide Severity Rating Scale (C-SSRS).
- •Presence of a severe, untreated psychiatric condition during the past year or history of psychiatric hospitalization in the last two years.
- •Determination by the University Wellness Team that the participant is not in a suitable condition to participate due to a severe psychiatric condition or need for hospitalization.
- •High severity of psychotic symptoms (score equal to or greater than 2 on any of items 13, 14, and/or 15 of the Community Assessment of Psychic Experiences - Positive Scale (CAPE, P15)).
研究组 & 干预措施
Reframe-IT+U
The Reframe-IT+U program is an individualized preventive intervention based on cognitive behavioral therapy, with a problem-solving and help-seeking approach, delivered within the University with psychologists and supervision. The program consists of six weekly sessions of 60-90 minutes each.
干预措施: Indicated Prevention for suicidality (Behavioral)
结局指标
主要结局
Client Satisfaction Questionnaire (CSQ-8)
时间窗: End of intervention at 6 weeks
It is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which rates each of the 9 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria from "0" (Never) to "3" (Almost Every Day). In Chile, it has been validated among people aged 20 years and over, with a sensitivity of 92% and a specificity of 89%, compared to the Hamilton Depression Scale. In addition, it has construct validity and concurrent predictive validity with the The International Classification of Diseases, 10th Revision (CIE-10) criteria for depression. The interpretation is made by adding the total of the first nine questions: 0-4 points, without depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.
Feasibility Assessment: Number of participants recruited
时间窗: through study completion, an average of 1 year
Initially, inclusion and exclusion criteria will be defined to ensure that participants are representatives of the target group. A tracking system will be implemented to monitor the number of people recruited.
Feasibility Assessment: Recruitment time for completion
时间窗: through study completion, an average of 1 year
A tracking system will be implemented to monitor the time needed to complete the recruitment process.
Feasibility Assessment: Evaluation of data collection and results.
时间窗: through study completion, an average of 1 year
Clear protocols will be established for data collection and analysis, ensuring accuracy and consistency. Statistical analyzes will be used to check the validity and reliability of the results.
Feasibility Assessment: Level of progress of the participants in the sessions.
时间窗: through study completion, an average of 1 yea
The completion and the time needed for completion of each module of the intervention will be registered.
次要结局
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Through study completion, an average of 1 year)
- Patient Health Questionnaire-9 (PHQ-9)(Through study completion, an average of 1 year)
- Generalized Anxiety Disorder (GAD-7)(Through study completion, an average of 1 year)
- Distress Tolerance Scale (DTS)(Through study completion, an average of 1 year)
- The Cognitive-behavioral Therapy Skills Questionnaire (CBTSQ)(Through study completion, an average of 1 year)
- Community Assessment of Psychotic Experiences Scale (CAPE-P15)(Through study completion, an average of 1 year)
- Brief Problem Solving Inventory (SPSI-R)(Through study completion, an average of 1 year)
- Difficulties in Emotion Regulation Scale - Spanish Version (DERS-E)(Through study completion, an average of 1 year)
- 12-item Short-Form Health Survey(Through study completion, an average of 1 year)
研究者
Jorge Gaete
Full Professor
Universidad de los Andes, Chile
