NCT06333444

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 19, 2024

Last Update Submit

March 26, 2024

Conditions

Keywords

university studentsuniversity counselling servicemental healthacademic motivation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Emotion regulation ability

    before and after the treatment, up to 7 weeks

  • perceived loneliness

    before and after the intervention, up to 7 weeks

  • drop-out intention

    before and after the intervention, up to 7 weeks

Study Arms (1)

Psychological intervention

EXPERIMENTAL

four weekly psychological counselling intervention

Behavioral: four weekly psychological counselling intervention

Interventions

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

Psychological intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • do not speak Italian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campania

Caserta, 81100, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25462401BACKGROUND
  • 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.

    PMID: 33671363BACKGROUND
  • 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.

    PMID: 27484622BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Gaia Caldarelli, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Four weekly psychological counselling intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 27, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations