University StudentsTRESPASSNCT06333444
Counselling Intervention for College Students Experienced Psychological Distress
A study testing four weekly psychological counselling intervention in people with University Students and Psychological Intervention, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- University Students, Psychological Intervention, Psychological Distress
- What is being tested?
- four weekly psychological counselling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being university students who asked psychological help to university counselling service and completed the intervention
Who cannot join
- do not speak Italian
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Campania
Caserta, 81100
ALDA TRONCONE, alda.troncone@unicampania.it
About this study
Official title: 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
Read the 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.
- Being tested
- four weekly psychological counselling intervention
- Keywords
- university students, university counselling service, mental health, academic motivation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
four weekly psychological counselling interventionBehavioural
four weekly psychological counselling intervention delivered by university students asking help to university counselling service in Southern Italy
| Study group | Role | What they receive |
|---|---|---|
| Psychological intervention | Experimental | four weekly psychological counselling intervention Receives: Behavioral: four weekly psychological counselling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: before and after the psychological intervention, up to 7 weeks
Secondary outcomes (3)
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
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.
Measured: 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.
Measured: before and after the intervention, up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for University StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Four weekly psychological counselling intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alda Troncone, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333444
- Sponsor's protocol ID
- n. 08, 09/03/2021
- Acronym
- TRESPASS
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only, if requested
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.
PubMed 25462401Batra 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.
PubMed 33671363Auerbach 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.
PubMed 27484622
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mentalization, Emotional Regulation and Loneliness in College Students' Psychological Distress
- ClinicalTrials.gov ID
- NCT06333444
- Acronym / sponsor ID
- TRESPASS / n. 08, 09/03/2021
- Keywords
- university students, university counselling service, mental health, academic motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Four weekly psychological counselling intervention
| Arm | Type | Receives |
|---|---|---|
| Psychological intervention | Experimental | Behavioral: four weekly psychological counselling interventionfour weekly psychological counselling intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- being university students who asked psychological help to university counselling service and completed the intervention
Key exclusion criteria (1 listed)
- do not speak Italian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| four weekly psychological counselling interventionfour weekly psychological counselling intervention delivered by university students asking help to university counselling service in Southern Italy | Behavioural | Psychological intervention |
Primary outcome
psychological distress
Time frame: before and after the treatment, up to 7 weeks
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.
Academic motivation
Time frame: before and after the psychological intervention, up to 7 weeks
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.
3 secondary outcomes
Emotion regulation ability
Time frame: before and after the treatment, up to 7 weeks
perceived loneliness
Time frame: before and after the intervention, up to 7 weeks
drop-out intention
Time frame: before and after the intervention, up to 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 25462401Beiter 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.
- Background: PubMed 33671363Batra 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.
- Background: PubMed 27484622Auerbach 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.
- Individual participant dataSharing planned: Undecided. only, if requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing four weekly psychological counselling intervention in people with University Students and Psychological Intervention, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alda Troncone, PhD (+39800252420 ext. +39800252420, alda.troncone@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological distress (time frame: before and after the treatment, up to 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333444, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.