Acceptability and Feasibility of a Universal Preventive Intervention

NCT06419868 | Not Yet Recruiting

• 1 other identifier: FDI UAN23102
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression/Anxiety

Keywords

Depression; Anxiety; Undergraduates; Universal prevention

Outcome Measures

Primary Outcomes (7)

• 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. The research team will develop an acceptability and satisfaction questionnaire and apply it to the intervention students.

  through study completion, an average of 1 year

• Feasibility Assessment: Number of participants recruited

  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.

  through study completion, an average of 1 year

• Feasibility Assessment: Recruitment time for completion

  A tracking system will be implemented to monitor the time needed to complete the recruitment process.

  through study completion, an average of 1 year

• Feasibility Assessment: Evaluation of data collection and results.

  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.

  through study completion, an average of 1 year

• Feasibility Assessment: Evaluation of the acceptability of the intervention

  Surveys will be used to collect opinions and perceptions of participants about the intervention and the methods used.

  through study completion, an average of 1 year

• Feasibility Assessment: Level of progress of the participants in the sessions.

  The completion and the time needed for completion of each module of the intervention will be registered.

  through study completion, an average of 1 year

• Client Satisfaction Questionnaire (CSQ-8)

  It is an 8-item instrument validated in English and translated and validated into Spanish that measures general satisfaction with health services received in various populations. The answers are Likert-type with four options each. In addition, there is space to write down comments and suggestions. This instrument will be slightly adapted to questions oriented to the study context. The Customer Satisfaction Questionnaire has an internal consistency ranging between α=0.83 and α=0.93. Each item on the CSQ-8 is rated on a 4-point scale, generally ranging from 1 (low satisfaction) to 4 (high satisfaction). Therefore, the minimum possible score on the CSQ-8 is 8 (1 point on each of the 8 items), and the maximum score is 32 (4 points on each item). A higher score on the CSQ-8 indicates greater client satisfaction with the services received, which is considered a better outcome. In this context, a higher score is better, as it reflects a better customer perception of the service.

  through study completion, an average of 1 year

Secondary Outcomes (11)

• 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

• PROMIS Global Health v1.2.: Patient-Reported Outcomes Measurement Information System (PROMIS)

  through study completion, an average of 1 year

• Distress Tolerance Scale (DTS)

  through study completion, an average of 1 year

• Insomnia Severity Index (ISI)

  through study completion, an average of 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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.

Interventions

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

Also known as: Cuidate

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Jorge E Gaete, MD, PhD

CONTACT

+56226181000; jgaete@uandes.cl

Valentina Romo

CONTACT

+56984038329; vromo@miuandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Professor

Model Details: This is an experimental study, with a randomized controlled trial design, with a control group.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 17, 2024
• Study Start: July 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study and until five years after the end of the study.
• Access Criteria: Any researchers who ask the principal investigator fot secondary analysis, data anonymized.