Acceptability and Feasibility of Reframe-IT+U for Suicidality in University Students.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de los Andes, Chile
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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)).
Trial design
Design model
Single group
Treatments tested in this trial
Indicated Prevention for suicidality
BehavioralThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Reframe-IT+UExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Client Satisfaction Questionnaire (CSQ-8)
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.
Time frame
End of intervention at 6 weeks2
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.
Time frame
through study completion, an average of 1 year3
Feasibility Assessment: Recruitment time for completion
A tracking system will be implemented to monitor the time needed to complete the recruitment process.
Time frame
through study completion, an average of 1 year4
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Columbia-Suicide Severity Rating Scale (C-SSRS)
The first 5 items explore the presence of suicidal ideation, intention, and planning and are assessed over the past month. The sixth item explores suicidal behavior either as preparation, initiation of a suicide attempt, or a suicide attempt itself in the last three months. Each item is answered Yes or No. It has been validated in an English-speaking population (range of internal reliability goes from α=0.73 to α=0.93) and a Spanish-speaking population (α=0.53). The total score range is from 0 to 6 points. According to the answers provided To the different items, the categories of severity of suicidal ideation are established: If the answer is "Yes" to item 1 and/or item 2 and "No" to all the other items, a slight risk is indicated. If the answer is "Yes" to item 2 and answer "Yes" only to item 3, it suggests that the risk is moderate. If the answer si "Yes" to item 2 and the answer is "Yes" to any of items 4, 5, and 6, it indicates that the risk is severe.
Time frame
Through study completion, an average of 1 year2
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame
Through study completion, an average of 1 year3
Generalized Anxiety Disorder (GAD-7)
GAD-7 was originally designed primarily as a screening and severity measure for generalized anxiety disorder, this instrument also has good performance characteristics for other common anxiety disorders: panic disorder, social anxiety disorder, and post-traumatic stress disorder. This consists of 7 questions. The score is calculated by assigning scores from 0 to 3 to response categories from "Never" to "Almost Every Day." It has been validated in Spanish, where a cut-off score of 10 showed adequate values of sensitivity (86.8%) and specificity (93.4%). The scale was significantly correlated with Hamilton Anxiety scal (HAM-A) (0.852, p \< 0.001), Hospital Anxiety and Depression Scale (HADS ) (anxiety domain, 0.903, p \< 0.001), and World Health Organization Disability Scale (WHO-DAS II) (0.696, p \< 0.001). The GAD-7 total score for the seven items ranges from 0 to 21
Time frame
Through study completion, an average of 1 year4
Distress Tolerance Scale (DTS)
This instrument allows us to evaluate how people experience and endure distressing psychological states. The scale is constructed of 15 items, divided into four subscales that measure four factors: Tolerance (items 1, 3, and 5), understood as the perceived ability to handle strong emotions; Relief (items 2, 4, and 15), considered as "how relieved a person feels when they experience a strong emotion"; Evaluation (items 6, 7, 9, 10, 11 and 12), understood as the person's perceived ability to accept their strong emotions; and, Regulation (items 8, 13 and 14), understood as the effort that a person makes to manage their intense emotions openly. DTS is a scale designed to be self-administered that is answered using a type format.
Time frame
Through study completion, an average of 1 yearLocations
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Source ClinicalTrials.gov
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