Counselling Intervention for College Students Experienced Psychological Distress (TRESPASS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Psychological Distress; Psychological Intervention; University Students
• Intervention / Treatment: Behavioral: four weekly psychological counselling intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alda Troncone, PhD; Phone Number: +39800252420 +39800252420; Email: alda.troncone@unicampania.it
• Study Contact Backup: Name: Gaia Caldarelli, PhD student; Phone Number: +39800252420 +39800252420; Email: gaia.caldarelli@unicampania.it

Study Locations

• Italy
  • Caserta, Italy, 81100
    • Recruiting
    • University of Campania
    • Contact: ALDA TRONCONE; Email: alda.troncone@unicampania.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• do not speak Italian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychological intervention; four weekly psychological counselling 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mental health; university students; university counselling service; academic motivation
• Other Study ID Numbers: n. 08, 09/03/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: only, if requested

Study Data/Documents

1. Informed Consent Form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No