Counselling Intervention for College Students Experienced Psychological Distress

Psychological Distress Clinical Trial

— TRESPASS  

Official title:

The Role of Mentalization, Emotional Regulation and Loneliness in College Students' Psychological Distress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333444
• Other study ID #: n. 08, 09/03/2021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Alda Troncone, PhD
• Phone: +39800252420
• Email: alda.troncone[@]unicampania.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.

The main question it aims to answer are:

• is the psychological counselling intervention useful in improving psychological distress and academic motivation

• which psychological variables predict the intervention outcome

Description:

The participants will be university students who completed psychological counselling intervention delivered by UCS (University of Campania, Italy). They will be asked to completed an internet-based survey, administered anonymously through Google Forms. The survey consist of two sections. The first section includes questions about sociodemographic characteristics (e.g., gender and age), enrollment year, type of university course attended, academic standing (i.e., whether all exams within the prescribed period had been passed), and previous or current contact with psychological or psychiatric mental health services (university or non-university). The second section comprises four scales that assessed the variables of interest.

To measure psychological distress and problems, the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) will be used. Feelings of loneliness will be assessed using the University of California-Los Angeles Loneliness Scale version 3 (UCLA-LS3). Emotion regulation will be assessed using the Difficulty in Emotion Regulation Scale (DERS). Students intentions to continue or to drop out of the academic course will be measured with self-reported questions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• being university students who asked psychological help to university counselling service and completed the intervention

Exclusion Criteria:

• do not speak Italian

Related Conditions & MeSH terms

• Psychological Distress
• Psychological Intervention
• University Students

Intervention

Behavioral:
• four weekly psychological counselling intervention
four weekly psychological counselling intervention delivered by university students asking help to university counselling service in Southern Italy

Locations

Country	Name	City	State
Italy	University of Campania	Caserta

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Auerbach RP, Alonso J, Axinn WG, Cuijpers P, Ebert DD, Green JG, Hwang I, Kessler RC, Liu H, Mortier P, Nock MK, Pinder-Amaker S, Sampson NA, Aguilar-Gaxiola S, Al-Hamzawi A, Andrade LH, Benjet C, Caldas-de-Almeida JM, Demyttenaere K, Florescu S, de Girolamo G, Gureje O, Haro JM, Karam EG, Kiejna A, Kovess-Masfety V, Lee S, McGrath JJ, O'Neill S, Pennell BE, Scott K, Ten Have M, Torres Y, Zaslavsky AM, Zarkov Z, Bruffaerts R. Mental disorders among college students in the World Health Organization World Mental Health Surveys. Psychol Med. 2016 Oct;46(14):2955-2970. doi: 10.1017/S0033291716001665. Epub 2016 Aug 3. Erratum In: Psychol Med. 2017 Nov;47(15):2737. — View Citation

Batra K, Sharma M, Batra R, Singh TP, Schvaneveldt N. Assessing the Psychological Impact of COVID-19 among College Students: An Evidence of 15 Countries. Healthcare (Basel). 2021 Feb 17;9(2):222. doi: 10.3390/healthcare9020222. — View Citation

Beiter R, Nash R, McCrady M, Rhoades D, Linscomb M, Clarahan M, Sammut S. The prevalence and correlates of depression, anxiety, and stress in a sample of college students. J Affect Disord. 2015 Mar 1;173:90-6. doi: 10.1016/j.jad.2014.10.054. Epub 2014 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychological distress	To measure psychological distress and problems, the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) (Barkham et al., 1998; Evans et al., 2000). The CORE-OM is a 34-item self-report measure that evaluates the level of psychological distress will be used. The measure covers four domains: subjective well-being (4 items), problems/symptoms (depression: 4 items, anxiety: 4 items, physical problems: 2 items, trauma: 2 items); life/social functioning (close relationships: 4 items, social relationships: 4 items, general functioning: 4 items), and risk to self and others (6 items). Higher scores indicate higher levels of distress. To distinguish between clinical and non-clinical cut-off values, the four dimensions (scales for both males and females) indicated in the original validation and the Italian version (Evans et al., 2002; Palmieri et al., 2009) will be considered.	before and after the treatment, up to 7 weeks
Primary	Academic motivation	The Academic Motivation Scale (AMS) is a 20-item self-report questionnaire designed to evaluate the regulation of motivation based on the self-determination theory. Academic motivation is conceptualized according to the degree of autonomy on which the individual behavior is based, expressed through a continuum of increasing self-determination, from not self-determined (amotivation pole) to self-determined (autonomous regulation pole) behavior, from being externally motivated to becoming internally and autonomously driven to perform certain behaviors. The items are rated on a five-point Likert scale (0 = does not correspond at all to 7 = corresponds exactly) and distributed in five subscales--amotivation, external regulation, introjected regulation, identified regulation, and intrinsic motivation. Scores frange from 0 to 140. High score subscale indicates higher endorsement of that motivation type.	before and after the psychological intervention, up to 7 weeks
Secondary	Emotion regulation ability	The Difficulty in Emotion Regulation Scale (DERS) is a 36-item multi-dimensional self-report measure of emotion dysregulation and emotion self-regulation strategies. The total scores range from 36 to 180, with higher scores indicating more difficulty in the emotion regulation component measured	before and after the treatment, up to 7 weeks
Secondary	perceived loneliness	The University of California-Los Angeles (UCLA) Loneliness Scale version 3 (LS3) is a 20-item self-report measure of an individual's subjective feelings of loneliness. Higher scores indicate greater loneliness. A total score = 47 will be considered indicative of higher-than-normal levels of loneliness.	before and after the intervention, up to 7 weeks
Secondary	drop-out intention	Students' intentions to continue or to drop out of the academic course will be measured with self-reported questions. For the present study, the Italian version, which consists of 4 items asking students how often they have thought about not continuing their university degree courses, will be adopted. Scores frange from 4 to 20. Higher scores indicate a greater intention to drop out.	before and after the intervention, up to 7 weeks

External Links

•   American College Health Association, 2020
•   American College Health Association, 2023